To compare the safety and efficacy of polyethylene glycol (PEG) versus placebo over a six-month treatment period in patients with chronic constipation.

PEG 3350 (Miralax^®) laxative 17 g or placebo was administered daily for six months. Patients were randomly assigned in a 2:1 ratio to PEG or placebo. This was a subjects mixed study. Medication was administered in 8 oz of juice or another beverage. Bisacodyl 10 mg (5 mg tablets) was used as rescue medication for severe discomfort related to constipation. Fiber was prohibited. Other nonconstipating medications were allowed.

• The study reported on a sample of 204 patients in the treatment group and 100 patients in the placebo group.
• Mean patient age was 53 years (range 20 to 92).
• The older adult subgroup comprised patients aged 65 years or older (n = 75).
• The sample comprised 258 women (85%).
• The sample was 84% Caucasian, 13% African American, and 3% Hispanic or Latino.
• Average duration of constipation was 23 years.
• Patients were included in the study if they had a three-month history of fewer than three bowel movements (BMs) per week when not taking laxatives and one or more remaining Rome symptom criteria. Patients also had an average of three or fewer satisfactory BMs per week during the 14-day observational period after eligibility criteria were met.
• Patients were excluded if they had loose stools, sufficient criteria for irritable bowel syndrome, and currently were being or previously had been treated with PEG.

50 centers in the United States

This was a double-blind, placebo-controlled, parallel, randomized controlled trial.

• During the 14-day observational period and qualification period, baseline constipation status was confirmed.
• During the treatment period, data were collected through an interactive voice response system daily to record BM experiences. Patients answered daily and weekly questions (e.g., number of BMs, straining, lumpy or hard stools, evacuation complete, satisfaction, cramping) on a Likert-type scale from 0 (none) to 4 (extreme).
• Amount of gas was rated on a Likert-type scale from 0 (no gas) to 4 (extreme gas).

• Of 609 patients screened, 300 did not meet criteria or failed the 14-day observational period. Of the remaining patients, 306 enrolled and were randomized, and 2 were excluded. A total of 175 patients completed the study.
• Primary analysis was based on intention to treat (ITT).
• Efficacy of the primary variable, treatment success, was defined as relief of modified Rome criteria for constipation for 50% or more of a patient's treatment weeks. The PEG group achieved significant benefit (p < 0.001) versus placebo in 11 of 12 primary and secondary measures.
• The total sample had a 41% difference in treatment response (52% in the PEG group versus 11% in the placebo group, p < 0.001).
• The older adult group had a 46% difference favoring PEG.
• The treatment group had more total BMs per week.
• Total compliance with study medication was higher than 86%.
• Patient withdrawal was equivalent for each reason category, except lack of efficacy; twice as many patients in the placebo group withdrew secondary to lack of efficacy.

PEG is safe and effective in management of constipation in adults and older adults for up to six months.

The study focused on chronic constipation and lacked focus on cancer or opioid-induced constipation.

To compare the safety and efficacy of polyethylene glycol (PEG) 3350 (Miralax^®) versus placebo for treatment of constipation in patients with chronic constipation.

PEG 3350 laxative 17 g or placebo was administered daily for 28 days. Use of nonconstipating medications was allowed, but the use of fiber or other laxatives was not permitted. Patients received a 4 L jug containing Crystal Light^® with or without study medication. The mixture was reconstituted by unblinded study personnel; investigators remained blinded. A daily bowel diary was used to share bowel movement (BM) experiences and answer questions related to study efficacy and safety criteria. Laboratory evaluation was repeated at study conclusion.

• The study reported on a sample of 100 patients (50 in the treatment group and 50 in the placebo group) enrolled and randomized within each site by computer; 93 completed the study.
• Mean patient age was 58 years (range 31 to 84).
• The older subgroup (aged 65 years or older) comprised 28 patients.
• The sample comprised 74 women (74%).
• The sample was 84% Caucasian and 16% African American.
• Mean duration of constipation was 18 years.
• Constipating medications included analgesics, anticholinergics, antidepressants, chemotherapy agents, anticonvulsants, antihistamines, and resins.
• Patients were included in the study if they had constipation as defined by Rome II criteria and were taking medication with a 3% or higher incidence of constipation.
• Patients were excluded if they had an allergy or sensitivity to study medication; had prior gastrointestinal (GI) surgery; had known or suspected GI obstruction, ileus, heart failure, renal failure, ascites, or another known chronic bowel or cardiopulmonary condition; were pregnant or lactating; had loose stool; met criteria for irritable bowel syndrome; and currently were taking or previously had taken PEG.

Four centers in the United States

This was a double-blind, placebo-controlled, parallel, randomized controlled trial.

• Relief of Rome II criteria for constipation during the last seven days of treatment period
• Total number of BMs
• Number of patient-reported satisfactory BMs
• Symptoms of gas, cramping, straining at stool, stool consistency, and bloating using a 10-cm visual analog scale

• Patient withdrawal was equivalent for each reason category except lack of efficacy. Three patients withdrew in the placebo group; none withdrew in the treatment group.
• Seventeen patients in the PEG group and 15 patients in the placebo group had analgesics associated with constipating medications. The primary responder for treatment success had a 39% difference in favor of PEG (78% in the PEG group versus 39% in the placebo group, p > 0.001). The older adult subgroup had similar results, but findings were not statistically significant because of the small sample size.
• Baseline constipation (fewer than three BMs per week) was evident in 58% (n = 29) of patients in the PEG group versus 46% (n = 23) of patients in the placebo group.
• Of 609 patients screened, 300 did not meet criteria or failed the 14-day observational period.
• Average BM per week in the final week was 8.1 in the PEG group versus 5.4 in the placebo group (p < 0.001).
• Two of three BMs were rated complete or satisfactory for both treatments.
• Treatment difference for straining and stool consistency was statistically significantly in favor of PEG (p < 0.001).
• No difference existed in gas, bloating, or cramps.

PEG is safe and effective in treating constipation in patients taking constipating medications.

• The study lacked an observational period prior to treatment initiation to confirm constipation status.
• Some patients in the study experienced constipation prior to receiving constipating medication. Medication-induced constipation may respond differently.
• Although the sample included patients with both opioid-induced constipation and chemotherapy-induced constipation, such patients were not included in sufficient numbers to provide dependable data. Additional study is needed.

To extend the safety data of polyethylene glycol used for chronic treatment of chronic constipation.

Polyethylene glycol laxative was administered as a single daily dose of 17 g for 12 months.

• The study reported on a sample of 311 patients with chronic constipation.
• 117 patients were aged 65 years and older.
• 184 patients completed all 12 months of treatment.
• Study participants who met defined criteria for chronic constipation were enrolled.

• Multicenter
• 50 centers in the United States

This was a randomized, open-label, single-treatment study.

• Patients returned to their study centers after 2, 4, 6, 9, and 12 months of treatment; blood and urine samples were collected, and adverse events were reviewed.
• At each visit, patients were queried for Rome constipation criteria and they rated their overall improvement using a global efficacy scale.

• No clinically significant changes were found in hematology or blood chemistry, particularly electrolytes, for the study population as a whole or the older adult group.
• With respect to the global efficacy assessment, depending on the month of observation, 80% to 88% of enrolled patients and 84% to 94% of older adults were treated successfully. Similar results were obtained from secondary efficacy measures that assessed individual Rome constipation criteria at each visit.
• The response to treatment was durable over time.
• Over the one-year course of study representing 218 patient-years at the labeled dose, medication-associated adverse effects were gastrointestinal complaints of diarrhea, loose stool, flatulence, and nausea. The effects were generally mild or moderate in severity.

Polyethylene glycol laxative is safe and effective for treating constipation in adult and older adult patients for periods up to 12 months, with no evidence of tachyphylaxis.

• None were identified in the discussion of the results.
• This study was not related to cancer or to opioid-induced constipation.

To assess the impact of early versus delayed (three months after patient diagnosis) initiation of palliative care for patients with advanced cancer on rural informal caregivers’ quality of life, burden (objective, demand, and stress), and depression

Caregivers were assigned to a palliative care intervention immediately following random assignment to groups (early or delayed) or three months after assignment. The telephone-based intervention, informed by authors’ earlier work sensitive to rural access issues, involved conversations between trained advanced practice palliative care nurse coaches and caregivers. Each coach provided three evidence-based content sessions delivered weekly in a scripted format. Each patient received a different coach than the family caregiver to support the open sharing of feelings about the caregiving experience. Coaches contacted their assigned caregivers on the telephone at least monthly to respond to emerging issues until patient death. Coaches encouraged caregivers to participate in patient palliative care consultations if acceptable to patient and called a caregivers when their family members died. All nurse coaches met weekly with study's primary investigator to support study integrity. To identify group differences on desired outcome measures, all caregivers completed three questionnaires at baseline and every six weeks until week 24.

• N = 122  
• MEAN AGE = 60 years
• MALES: 21.3%, FEMALES: 78.7%
• KEY DISEASE CHARACTERISTICS: Patients' predominant diagnosis was advanced gastrointestinal or lung cancer  
• OTHER KEY SAMPLE CHARACTERISTICS: 93% white; 80% completed high school or college; more than half employed; 29% retired; 62% professed Catholic or Protestant religious beliefs; 75% were the spouse or partner of a patient with cancer 

• SITE: Multi-site  
• SETTING TYPE: Outpatient    
• LOCATION: New Hampshire and Vermont

• PHASE OF CARE: End-of-life care
• APPLICATIONS: Palliative care 

Randomized, controlled trials with a wait-control design

• Caregiver Quality of Life Scale: Cancer (CQOL-C0)
• Center for Epidemiologic Studies Depression (CESD) Scale
• Montgomery Borgatta Caregiver Burden (MBCB) Scale
• High reliability and validity assessment indices provided by authors

More than 30% of participants did not complete all the follow-up assessments although the authors used appropriate statistics to confirm there was no significant relationship of attrition and measured characteristics of caregivers. The early intervention group showed a decline in depression scores from baseline compared to the delayed group (d –0.32, p = 0.02). There were no differences between the groups in quality of life or burden scores. Among the caregivers of patients who died, results for depression (p = 0.02) and stress burden (p = 0.01) were better in the early intervention group. All measures showed decline somewhat in both groups.

Study data support that well-educated, white, female caregivers experience improved quality of life, less depression, and less burden with early involvement in palliative care programs distinct from similar patient programs. More studies of minority populations, male caregivers, and low literacy populations receiving similar programs could increase the generalizability of the current study's findings.

• Findings not generalizable
• Subject withdrawals ≥ 10%
• Other limitations/explanation: No inclusion criteria for caregivers except those caring for patients who met certain criteria (potential selection bias); sample mainly white with high school or more education levels living in close geographical distance to affect generalizability of results; 32% of caregivers did not complete all assessments (authors do not note rationale, seems patients became more ill and needed caregiver assistance); caregiver exclusion criteria did not clarify if a caregiver was excluded if he or she had cancer, a diagnosis of depression, or health issues that affected quality of life or perceived burden

Nursing knowledge and the clinical competency of support provision for early palliative care programs to family caregivers and patients challenged by end-of-life issues is important. The American Nurses Association Code for Nurses supports the ethical responsibility of nurses to ensure that both groups receive evidence-based programs tailored to patients and caregiver groups to meet current healthcare goals for person-centered care.

• To determine the clinical efficacy of Mepilex Lite dressings in reducing radiation-induced erythema in women with breast cancer receiving radiation therapy treatments 
• To determine the effect of Mepilex Lite dressings on dose build-up and on surface skin temperature
• To determine the dose distribution over the breast
   

When erythema was visible (generally 10–14 days after first fraction), each affected skin area was randomly divided into two similar halves: one was treated using Mepilex Lite dressings, the other with standard aqueous cream. Mepilex Lite dressings are absorbent, self-adhering dressings consisting of a thin flexible sheet of absorbent hydrophilic polyurethane foam bonded to a water vapour-permeable polyurethane film backing layer. The contact surface of the dressing is coated with a soft silicone adhesive layer without any added chemicals, providing a moist wound-healing environment. Dressings were positioned by a research radiation therapist on half of the area where erythema was present, with the location marked by semi-permanent marker so patients could accurately reposition dressings after showering. The other half continued to be treated with aqueous cream. Allocation of dressings and controls was random based on order of entry into the trial. Skin areas were designated as superior/medial or inferior/lateral. Radiation-Induced Skin Reaction Assessment Scale (RISRAS) scores were determined three times a week (Monday, Wednesday, and Friday) from the moment erythema was visible until completion of radiation treatment. Two more assessments were completed one week after completion of treatment and at the final check-up (usually four weeks after completion of treatment). Because anecdotal evidence suggested the dressings may have a cooling effect, skin temperature of the 10 patients was measured three times a week during every skin assessment. The study endpoint was development of dry desquamation as departmental protocol is to cover any area of dry desquamation with Mepilex Lite dressings, thus removing control side of clinical trial.
 

• The study sample (N = 24) was comprised of female patients receiving radiation therapy treatment for breast cancer.
• Mean age was 58 years, with a range of 43–79 years.
• A total of 34 areas of erythema were treated (eight women had two separate areas for analysis and one woman had three separate areas for analysis).
• Patients were excluded from the study if they had radical mastectomy, fractionation regimes other than 50 Gy per 25 fractions, prone treatment position, impaired mobility, or fungating tumor.
• One woman was Maori/Lebanese and all others were Caucasian.
• Surface areas analyzed ranged from 50–150 cm².
• Chemotherapy was given prior to radiation treatment for six women (5- ACT, 1- FEC). 
• Five women smoked at time of study and seven women had previously smoked. 
• All trial participants received 50/25 fractions; in addition, four women received boosts to their axilla and upper-outer breast quadrant and one woman received a boost to the superior anterior breast and upper-inner breast quadrant.

The study took place at a single site in New Zealand.

Patients were undergoing the active treatment and transition phase. The study has clinical applicability to late effects and survivorship care.
 

The study used a quasi-experimental, unblinded design. The study was labeled by investigators as a systematic inpatient randomized controlled clinical trial.

• Extent of erythema was measured using a modified RISRAS scale. The scale consists of a research component (visible extent of skin reaction) and a patient component (level of pain, itchiness, burning and effect on day-to-day life). Because the trial end point was dry desquamation, only extent of erythema (0–4) was included in the research component.
• Tissue maximum ratio measurements were taken at various depths when a Mepilex Lite dressing was applied to the surface to calculate its bolus effect. Measurements were taken with a white water phantom chamber in combination with PTW Unidos E electrometer.  Readings were made with and without the Mepilex Lite dressing on the surface of the phantom over the chamber.  The maximum value was determined for each energy level.
• Surface skin temperature was measured using an infrared thermographic scanner to detect subtle skin temperature variations scores across the control and Mepilex areas. Skin temperature was measured for the first 10 patients three times a week during every skin assessment.
• Thermoluminescent dosimeters (TLDs) were used to calculate the actual dose received by the skin in different areas of the breast, comparing dose that had been received with the dose that the planning system intended giving. They were also used as a reference point for the level of skin reaction experienced by the patient. TLDs were placed in seven areas on the breast as outlined per protocol.

• Mepilex Lite dressings had a very small bolus effect. The difference in dose between Mepilex and control under two different beams was shown to decrease with depth, demonstrating a 0.5 mm difference in dose build-up.
• Mepilex Lite dressings decreased the extent of radiation-induced erythema. The average increase in combined, researcher and patient RISRAS scores for the 34 areas of skin analyzed showed the dressings significantly decreased the extent of the radiation-induced erythema (p < 0.001). Most of the patients (71%) preferred the dressings over the cream and commented that the dressings were soothing, providing pain relief and relief from friction.
• Mepilex Lite dressings did not affect surface skin temperature. The average difference between the surface skin temperature of the dressed and undressed areas was statistically insignificant in the first 10 patients (p = 0.77). Temperature measurements were not completed in the remainder of patients.
• Breast regions at risk from radiation-induced side effects were measured by TLDs. The inframammary fold received the highest dose regardless of breast size, which was highly statistically significant (p < 0.00001). Most patients (67%) developed moist desquamation in their inframmary fold. 
• Twenty-four percent of skin areas treated with aqueous cream broke down to reach dry desquamation. These patients were stopped from further participation in the trial as departmental protocol was to apply Mepilex Lite dressings to dry desquamation. Fifteen percent of skin areas dressed with Mepilex Lite developed dry desquamation. Dry desquamation led to moist desquamation in all instances, suggesting that the dressings may decrease the number of skin areas reaching moist desquamation. Moist desquamation was not part of the trial outcomes.
   

Mepilex Lite dressings decreased the severity of radiation-induced erythema in patients with breast cancer treated with radiation therapy. The majority of patients preferred the dressings over the cream and thought they increased comfort levels, decreased the amount of pain experienced, and allowed patients to wear normal clothing. Mepilex Lite dressings did not affect surface skin temperature and did not cause a significant dose build-up.  
 

• The study had a small sample size, with less than 30 patients.
• The study took place at a single site.
• The study had a potential risk for bias because of randomization of skin areas based on date of entry to the trial (computer-generated randomization numbers should be considered in future trials) and lack of blinding.
• Most insurances do not cover dressings for non-draining skin issues. The expense of application of Mepilex Lite dressings at the time of erythema would be cost prohibitive to many patients undergoing radiation treatment.
• The end point of this trial was dry desquamation. RISRAS measurements were stopped when the end point was reached, possibly obscuring the effects of Mepilex Lite dressings as skin toxicity progresses to moist desquamation.
   

What are insurance implications for patients who would potentially benefit from Mepilex Lite? Further studies with larger sample sizes, multiple centers, and other treatment areas known to demonstrate increased skin toxicity are needed.

To evaluate the effect of dietary supplements in reducing skin toxicity due to radiotherapy in patients with breast cancer

Patients were treated with either dietary supplements or use of topical prophylactic hyaluronic acid and a topical steroid therapy in case of occurrence of radiodermatitis. Patients who were treated with dietary supplements were perscribed resveratrol, lycopene, vitamin C, and anthocyanins at a does of 2 tablets per day. Patients were not randomly assigned.

• The study sample (N = 71) was comprised of female patients.
• Age ranged from 30–80 years.
• Some patients were receiving adjuvant chemotherapy as well

The study took place in an outpatient setting.

Patients were undergoing active antitumor treatment.

 The study used a retrospective observational design.

Patients were assessed using the Radiation Therapy Oncology Group and European Organisation for Research and Treatment of Cancer skin toxicity scale.

In patients evaluated at various radiation therapy doses, odds ratios and relative risk of development of grade 0–1 and 2–3 skin toxicity were calculated.  All ratios were less than 1.0, which cannot be evaluated. No statistically significant differences were reported, and no analysis of significance was provided.

The study does not provide or report sufficient evidence to draw any conclusions.

• The study had a small sample size, with less than 100 participants.
• The study had a risk of bias due to no control group, blinding, or random assignment.
• Measurement and methods were not described.
• Measurement validity and reliability are questionable.

The study does not provide evaluative evidence for use of dietary supplements to prevent radiodermatitis.

To compare differences in the number of platelet transfusions received and episodes of hemorrhagic bleeding, based upon a prophylactic transfusion trigger of either less than 10 x 10⁹ per L or less than 30 x 10⁹ per L, in patients undergoing allogeneic hematopoietic progenitor stem cell transplants

Patients were randomized (after stratification) to receive prophylactic platelet transfusions at either less than 10 x 10⁹ or less than 30 x 10⁹ per L. The number of transfusions received, the types of bleeding episodes, and the number of red blood cell transfusions were recorded 7 days pre- to 30 days post-transplantation. The results of the morning lab draws identified the need for transfusion based upon the trigger group (T 10 or T 30). In addition, patients were assessed daily (if inpatient) and twice weekly (if outpatient) by nurses blinded to the treatment arm. A special research nurse was used to collect study data. 

• N = 166  
• AGE RANGE = 1–63 years
• MALES: 52%, FEMALES: 48%
• KEY DISEASE CHARACTERISTICS: Patients undergoing transplants for non-malignant, acute, or chronic leukemia, or other solid tumor malignancy. Exclusion criteria included known bleeding disorders or coagulopathy.

• SITE: Single-site    
• SETTING TYPE: Inpatient    
• LOCATION: University Hospital in Sweden

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Pediatrics

Prospective, randomized trial

• World Health Organization (WHO) criteria

There were no significant differences between the groups based upon donor type, origin of hematopoietic progenitor cells, age, or conditioning regime used. There was a significantly lower number of transfusions received in the T 10 group (median 4 versus 10, p < 0.001) without a significant difference in the episodes of bleeding between groups.

The evidence suggests that the trigger for prophylactic platelet transfusions in patients undergoing allogeneic hematopoietic progenitor stem cell transplants may be safely decreased from 30 x 10⁹ to 10 x 10⁹ per L.

Note that the logistic regression multivariate analysis of factors associated with platelet transfusions before day 30 and before day 60 demonstrate wide confidence intervals (95% CI, 3.08–18.7 and 95% CI 1.82–9.67, respectively).

Nurses will care for patients at risk of life threatening bleeding and need to be aware of indications for platelet transfusion. A lower threshold for prophylactic transfusion may conserve the blood supply.

To determine if chewing gum is efficacious in the prevention and treatment of oral mucositis in children receiving chemotherapy regimens

• Permission from institution
• Written informed consent obtained from parents of each child
• Interview with parent and child to elicit demographic information
• The study group consisted of children chewing nonsugary gum for 10 days three times daily for 20 minutes (abstaining from drinking water one hour before chewing gum).
• Both study groups used Tantum^® mouthwash for standard oral care and continued usual tooth brushing.
• Children’s oral assessments were performed on day s1, 5, and 10 using the World Health Organization (WHO) Oral Mucositis Index (OMI). An Eilers’ Oral Assessment Guide with pH measurements was taken.
• All assessments were performed by the same researcher.

• N = 60  
• AGE RANGE = 6–18 years
• MALES: 48.33%, FEMALES: 51.7%
• KEY DISEASE CHARACTERISTICS: Acute myeloid leukemia, acute lymphoblastic leukemia, Hodgkin lymphoma, and Wilms tumor
• OTHER KEY SAMPLE CHARACTERISTICS: Duration of hospitalization by day, number receiving chemotherapy, and duration of disease by year

• SITE: Single site
• SETTING TYPE: Inpatient pediatric oncology clinic at a university hospital
• LOCATION: Istanbul

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Pediatrics

Quasi-experimental study with a control group

• World Health Organization (WHO) Oral Mucositis Index (OMI)
• Eilers’ Oral Assessment Guide (EOAG)
• Intraoral pH assessment measured by researchers within one minute after chewing using pH colormatic strips placed under the tongue for two minutes (values ranged from 4–9)

• Acute lymphoblastic leukemia was the most common diagnosis.
• No statistical difference between demographic data in both control and study groups related to age, gender, or educational states was found.
• At end of the study, significant difference (p < 0.5) in mucositis severity between the two groups existed.
• At the start of study, the average pH value was 5.8 (SD = 0.6) for the study group and 5.9 (SD = 0.3) for the control group. At end of study (day 10), the average pH value was 6.4 (SD = 0.2) in the study group and 6 (SD = 0.3) in the control group. This was statistically significant (p < 0.5).

Chewing gum was an effective option for preventing and treating oral mucositis in pediatric patients with acute lymphoblastic leukemia, acute myeloid leukemia, Hodgkin lymphoma, and Wilms tumors.

• Small sample (< 100)
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Unintended interventions or applicable interventions not described that would influence results
• Findings not generalizable
• Other limitations/explanation: Unintended interventions such as avoiding certain foods or using ice chips at home were not described. Not all children had the same mucositis severity in this study. The type of gum was not described and its ingredients were not described.

• This study indicated a potential treatment and prevention intervention for pediatric patients with cancer.
• Its findings point to areas for additional nursing research.
• The intervention was low-cost, accessible, and easy to administer.

The experimental group underwent complete decongestive therapy that included lymph drainage using the Foldi method, multilayer compression bandage, elevation, remedial exercises, and skin care. The control group underwent standard physical therapy that included compression bandages, elevation, head-neck and shoulder exercises, and skin care. Both groups had a home program of bandaging, skin care, and walking. Therapy was three times per week for four weeks.

• The study sample (N = 53) was comprised of patients with lymphedema post-breast cancer treatment.
• Patients were randomly assigned and blinded to the intervention in the experimental group (n = 27) or the control group (n = 26).
• Average duration of lymphedema at the time of treatment was three years.
• Patients were experiencing mild-to-moderate lymphedema; mild lymphedema (n = 21) was defined as a 2 cm circumference difference and moderate (n = 32) a difference of 2–5 cm.
• Patients were excluded from the study if they had
  • Obvious psychiatric illness
  • Severe pain in the axillary region
  • Severe cardiac disease
  • Uncontrolled hypertension
  • Malignancy.
• The average mean volume was 580 ml.
• Patients were assessed for type of breast cancer procedures, but this was not used for characterizing the sample.
• Of patients in the sample, 24.4% had lumpectomies, 64.2% had modified radical mastectomies, and 11.3% had radical mastectomies.
• Nine patients had a history of cellulitis, and 44 had no infection.
• All patients had axillary dissection with a range of 2–35 nodes removed.

The study used a prospective trial design.

• Range of motion, circumference measurement, and volumetric measurement were assessed before and after treatment.
• Circumference measurements were taken using a standard one inch, retractable, fiberglass tape measure.
• Measurements were taken from 10, 15, and 20 cm above and below the olecranon process, at wrist, and at metacorpophalangial joints.
• Measurements always were taken twice.
• The same procedure was used for the unaffected arm of each participant.
• The arm was placed in water-filled container and displaced water was measured.
• Shoulder mobility was measured using goniometry.
• Function was measured as the active mobility with extension-flexion, abduction-adduction, and external rotation.

Mean percentage reduction in edema was 55.7% in the experiential group and 36% in control group (p < 0.05). Only 45% had limitation of range of motion to start. Reduction in shoulder mobility was 48.1% in the experiential group and 42.3% in control group before treatment. Shoulder flexion and abduction movements in both groups were increased after treatment (p < 0.05). No significant difference was found in shoulder external rotation in both groups (p > 0.05). No difference was found between groups in shoulder mobility.

Patients were similarly classified using circumferential and volumetric measurements; therefore, either of the methods can be used.

• The sample size was small, with less than 100 patients.
• Patients had extensive disease of more than three years duration.
• The tissue was not described.
• Lymphedema was not staged.

The study included an experimental group and a control group. The experimental group received complete decongestive therapy (CDT) that included lymph drainage (Foldi method), multilayer compression bandage, elevation, remedial exercises, and skin care. The control group received standard physical therapy that included compression bandages, elevation, head and neck and shoulder exercises, and skin care. Both groups had a home program of bandaging, skin care, and walking. Therapy was three times per week for four weeks.

• The study sample (N = 53) included 27 experimental group patients and 26 control group patients who were randomly assigned and blinded to the intervention.
• All patients had mild (n = 32) or moderate (n = 21) lymphedema post-breast cancer treatment (2 cm circumference difference was defined as mild lymphedema, and 2–5 cm circumference difference was defined as moderate).
• Average duration of lymphedema at the time of treatment was three years; all patients had experienced lymphedema for more than one year. 
• Patients measuring 2–5 cm were excluded from the study based on obvious psychiatric illness, severe pain in axillary region, severe cardiac disease, uncontrolled hypertension, or malignancy.
• The average mean volume was 580 ml. 
• Patients were assessed for type of breast cancer procedures, but the sample was not characterized by them.
• Of the 53 patients who were post-breast cancer treatment, 24.4% had lumpectomies, 64.2% modified radical mastectomies, and 11.3% radical mastectomies. In addition, 13.2% received chemotherapy and 49.1% hormonal therapy. 
• All patients had axillary dissection with a range of 2–35 nodes removed and a mean of 24.2.

The study took place at a school of physical therapy.

A prospective trial design was used.

• Range of motion, circumference measurement, and volumetric measurement were assessed before and after treatment.
• Circumference was measured using a standard one-inch, retractable, fiberglass tape measure.
• Measurements were taken from 10, 15, and 20 cm above and below the olecranon process, at wrist, and at metacorpophalangial joints.
• Measurements always were taken twice.
• The same procedure was used for the unaffected arm of each participant.
• To measure volume, the arm was placed in a water-filled container and displaced water was measured.
• Goniometry was used to determine shoulder mobility. 
• Function was measured as the active mobility with extension-flexion, abduction-adduction, and external rotation.

• Mean percentage reduction in edema was 55.7% in the experimental group and 36% in the control group (p < 0.05).
• Only 45% of patients had limited of range of motion to start. Reduction in shoulder mobility was 48.1% in the experimental group and 42.3% in control group before treatment.
• Shoulder flexion, abduction movements in both groups were increased after treatment (p < 0.05).
• No significant difference was found in shoulder external rotation in both groups (p > 0.05).
• No difference between groups in shoulder mobility was found.
• Similar patient classification was found using circumferential and volumetric measurements.

Either of the methods can be used.

• Patients had extensive disease of more than three years' duration.
• No description of the tissue (pitting fibrotic) was provided.
• Lymphedema was not staged.
• The sample size was small.