To identify the baseline prevalence of lymphedema in the PAL cohort according to three standard diagnostic methods commonly used in clinical practice and/or research, and to compare the effect of the weight-lifting intervention on lymphedema outcomes using these same three diagnostic methods.

The study evaluated the women’s lymphedema status at baseline and 12 months using four independent standardized methods: volumetric, sum of arm circumferences, bioimpedance spectroscopy, and validated self-report survey.  In the PAL trial women were randomized to progressive weight lifting or usual care.

• The study sample was comprised of 295 female patients who were randomly allocated to the weight-lifting (n = 148) or control (n = 147) group.
• Mean age for the weight-lifting group was 55 years and mean age for the control group was 57 years.
• Patients were included in the study if they had
  • A history of unilateral nonmetastatic breast cancer
  • A body mass index of less than or equal to kg/m²
  • At least one excised lymph node
  • No recurrence of breast cancer and no clinical signs or symptoms of breast cancer
  • Stable lymphedema, defined as greater than or equal to 10% inter-limb discrepancy in volume or circumference at point of greatest visible difference
  • Swelling or obstruction of the anatomic architecture on close inspection
  • Pitting edema
  • Prior diagnosis of lymphedema, having had any prior intensive lymphedema therapy on the affected arm
  • Self-reported clinical diagnosis of lymphedema that was later confirmed by study measurements or by qualified clinician.
• Patients were defined as having lymphedema or not according to the Physical Activity Lymphedema (PAL) Trial definition.
• Patients were excluded from the study if they had
  • Unstable lymphedema defined as needing intensive lymphedema therapy within three months before entry into study
  • 10% change in volume or circumference of affected arm that had lasted at least seven days within three months before entry into study
  • Lymphedema-related infection that required use of antibiotics within three months before entry into study
  • Required a change in activities of daily living in response to exacerbation of lymphedema within three months before entry into study.

The study took place across multiple settings in Pennsylvania.

The study has clinical applicability for late effects and survivorship.

The study used a secondary analysis of a randomized controlled trial design.

• Arm volume was measured using the water displacement method.
• Arm circumference was measured.
• Bioimpedance spectroscopy was used.
• Patients provided a self-reported that was validated.
• Statistical analysis included Chi square test and Fisher’s exact test to compare categorical variables, continuous variables compared with Student’s t test, and Wilcoxin rank sum test.

There were no clinical or statistical differences in personal and treatment characteristics between the weight-lifting and control group. The authors identified that irrespective of the lymphedema diagnostic criteria used, weight lifting did not initiate nor exacerbate lymphedema. The PAL Trial’s definition for lymphedema identified 48% of the 295 participants as having lymphedema. When specific diagnostic criteria were independently applied to the cohort, lymphedema was clinically evident between 22% (sum of circumferences) and 52% (Norman survey). When all four criteria were applied, only 19% were considered to have lymphedema.

It is important to consider that the variations in lymphedema cohort and intervention studies may be reflected by these different diagnostic methods. It is important to consider the strengths and limitations of each criteria in light of the cohort being assessed. The results of the study may change the previous recommendations of restricting repetitive exercise; this study highlights that women should be encouraged and not restricted to participate in programs. Results also suggest large differences in reported lymphedema incidence based on the definitions used.

Unintended interventions or applicable interventions were not described and would influence results.

Findings suggest that progressive weight lifting does not exacerbate lymphedema. Still, we should caution that women in the PAL Trial were supervised and closely monitored for changes in signs or symptoms of lymphedema. The study was not powered to evaluate whether weight lifting could prevent lymphedema.

To investigate the effect of participating in a supervised, mixed-type exercise program on lymphedema status among women with lymphedema after breast cancer

All measures were assessed before the intervention, immediately after the intervention, and at 12-week follow-up and were conducted by the same assessor who was blinded to participant group allocation. Participants were randomly allocated to the intervention group or the control group after being assessed before the intervention. The intervention involved a 12-week, mixed-type exercise program, including aerobic and resistance exercise.

• The study sample (N = 32) was comprised of female patients with breast cancer.
• Mean age of the sample was 59 years.
• Patients were objectively measured by Perometer with greater than 200 ml differences.
• Another 106 women who provided patient and treatment information were unable to participate because of the intervention requirements.

The study took place in an outpatient setting in Queensland.

The study used a randomized controlled trial design.

• Lymphedema was assessed via bioimpedance spectroscopy and perometry.
• Qualitative comments regarding the program and the lymphedema status provided by the women during exercise sessions were recorded.

There were no significant differences in lymphedema status at baseline or changes between testing phases observed between the intervention and control groups.

Women with lymphedema can safely participate in this type of education.

• The study had a small sample size (N < 100).
• Intervention requirements caused many patients (N = 106) to be ineligible.
• Generalizability for all the women treated for breast cancer should be cautioned.
• The study reported on short-term follow-up only.

Nurses should be aware that, at minimum, exercise does not exacerbate secondary lymphedema. Women with secondary lymphedema should be encouraged to be physically active, optimizing their physical and psychosocial recovery.

To evaluate two modes of delivery of an exercise intervention:  provided either face-to-face or via the telephone.

Women were randomized to one of three groups:  face-to-face exercise, telephone exercise intervention, or usual care.  For those in the exercise interventions, the intervention involved 16 sessions, starting weekly and tapering to monthly contact after four months.  The exercise prescription was provided in sessions to progress to exercising 45 minutes at least four days per week, incorporating both aerobic and strength-based exercise.  Assessments were performed at baseline and six weeks, six months, and 12 months postsurgery.

• One hundred ninety-four participants were included.           
• Median age was 52 years (range 29–70).
• One hundred percent of patients were female.
• All patients had breast cancer; 69% were getting chemotherapy during the trial, 71% were receiving radiation therapy, and 64% began hormone therapy.

• Single site       
• Outpatient        
• Australia

Patients were undegoing the active antitumor treatment phase of care. 

This was a single-blind, randomized, controlled, longitudinal study.

• Functional Assessment of Cancer Therapy (FACT) – Breast
• Functional Assessement of Chronic Illness Therapy – Fatigue (FACIT)
• Disabilities of the Arm, Shoulder, and Hand Questionnaire
• Greene Climacteric Scale
• Neuropathic pain scale
• Three-minute step test (fitness measure)

Upper body function and adverse effects, such as menopausal symptoms, pain, anxiety, and depression, improved over time for all patients, with no differences between groups. The adherence rate was 88% in the face-to-face exercise group and 81% in the telephonic intervention group.  Patients in both exercise intervention groups showed greater improvement in fatigue symptoms over time (p = 0.032). At the end of the study, fatigue scores improved by 4.9 points in the face-to-face intervention and by 6.8 points in the telephonic group.  In the usual care group, fatigue initially got worse; however, scores improved by 4.6 points by 12 months. Sixty-six percent of those in the usual care group also participated in at least 180 minutes of physical activity per week and had an increased level of activity from baseline.  Quality of life improved significantly more in the intervention groups over time (p = 0.03)

Findings suggested that delivery of an exercise prescription and instruction via the telephone can be an effective method of delivering an exercise intervention for women with breast cancer.  Results of this study support those of others demonstrating improvement in symptoms in all patients over time, but significantly greater improvement in fatigue with exercise interventions.

• The study had risks of bias due to no blinding and no appropriate attentional control condition.
• Unintended interventions or applicable interventions not described would influence the results.
• Findings were not generalizable.
• Patients were not blinded, and it was noted that control group patients also increased their activity, which could have confounded the results.  Although adherence to the exercise intervention was measured, mainly educational and motivational in nature, actual performance of exercise was not clearly measured.

Findings suggested that providing an exercise prescription might be an effective way to engage patients in exercise, which can reduce symptoms of fatigue.  This study demonstrated that providing an exercise program intervention via telephone contact can be as effective as engaging patients in a face-to-face intervention. This suggests that telephonic contact to teach and motivate patients to exercise may be an effective and practical way to deliver an intervention.

Databases searched were PubMed, EMBASE, and Cochrane Collaboration.

Search keywords were intrathecal pump for pain, intrathecal infusion, spinal infusion, intrathecal drug delivery system, spinal pump, and intrathecal therapy.

Studies were included in the review if they

• Involved long-term use of intrathecal infusion implants for chronic pain.
• Provided a minimum of three-months follow up.
• Reported on patients with no previous spinal surgery.
• Used any study design.

Studies were excluded if they

• Lacked clear delivery system documentation or used mixed delivery systems.
• Were case reports, technical reports, surveys, or pump evaluations.

The initial search yielded 812 references; 59 of these were reviewed. A final sample of 20 studies was included. Of these, one randomized trial and four observational studies involved cancer pain. Study quality was evaluated using Agency for Healthcare Research and Quality (AHRQ) criteria for observational studies and Cochrane criteria for randomized controlled trials (RCTs).

For cancer-related pain, the final sample of five studies involved 482 patients with refractory pain and end-stage disease. Samples ranged from 35–202. Five systematic reviews also were included in the review; however, none of these specifically addressed cancer-related pain.

Overall, moderate quality level evidence was found with cancer-related pain. Three out of five of the studies showed 30% or greater pain relief at three months, and four out of five studies showed 50% or greater pain relief at three months. All studies showed improvement in both nociceptive and neuropathic pain control. Studies showed reduced complications with opioids. Complications occurred related to devices, the surgical implant procedure, or other procedure-related aspects in three studies. In one study, miscalculation of pump refill dates resulted in severe pain among five patients.

Long-term efficacy and safety of the intrathecal approach in terminal cancer is justified, and data supports the use of chronic intrathecal morphine for treatment of intractable malignant pain. Problems and complications can occur. Device-related complications and the need for surgical revision appear to have occurred at higher rates in earlier studies compared to more recent studies, which reflects ongoing improvements in techniques and education. Initial assessments of cost effectiveness suggest that cost savings are achieved after two years in comparison to systemic therapy in noncancer pain.

Patient selection and experience with implanted devices are important considerations in decision making for use of intrathecal pain management. Patient and caregiver self-care education is key to the safety and efficacy of this approach.

To evaluate the clinical effect of a newly developed lozenge containing polaprezinc for the prevention of oral mucositis in patients who received conditioning high-dose chemotherapy for hematopoietic stem cell transplantation (HSCT) compared to a polaprezinc (zinc-L-carnosine) suspension in a sodium alginate solution that has been shown to be effective in the prevention of oral mucositis in patients who received radiotherapy or high-dose chemotherapy

Patients were pretreated with either polaprezinc suspension during January 2013 and December 2014 or polaprezinc lozenge during January 2015 and December 2016 for the prevention of oral mucositis. The control group consisted of patients who received high-dose chemotherapy without any premedication during March 2006 and February 2011. The incidence and severity of oral mucositis and its associated symptoms, such as oral pain, were reviewed from medical records and compared among the three groups. The severity of adverse events was graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 3.0.

• N = 66
• AGE RANGE = 19–70 years
• MALES: Not given  
• FEMALES: Not given 
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: Acute myeloid leukemia, acute lymphoblastic leukemia, acute promyelocytic leukemia, myelodysplastic, natural killer/T-cell lymphoma, diffuse large B-cell lymphoma, mantle cell lymphoma, follicular lymphoma, Hodgkin lymphoma

• SITE: Single site   
• SETTING TYPE: Inpatient    
• LOCATION: Japan

PHASE OF CARE: Active antitumor treatment

Retrospective cohort comparison

CTCAE, version 3.0

The results showed grade 2 and grade 3 oral mucositis in the no-premedication control group. The polaprezinc suspension group and the polaprezinc lozenge group showed less incidence of grade 2 mucositis, and the overall average grade of oral mucositis was 0.6 for the suspension group and lozenge group. No statistical difference existed in the average grade or incidence rate of oral mucositis between the suspension group and lozenge group.

The newly developed lozenge containing polaprezinc for the prevention of oral mucositis was shown to be highly effective in the prevention of moderate to severe oral mucositis in patients receiving high-dose chemotherapy for HSCT. There was some question about the efficacy of the lozenge preparation when compared to the suspension.

• Small sample (< 100)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Key sample group differences that could influence results 
• Measurement/methods not well described
• Intervention expensive, impractical, or training needs

Gender was not clearly identified, and the method of evaluating the grade of mucositis was not clearly described. The lozenge is not a readily available product, developed and compounded for this study. The product has promise if the study is replicated as randomized, controlled trial.

To evaluate the effect of implementation of institutional guidelines (12 mg dexamethasone alone) for low-emetic risk chemotherapy with docetaxel and to estimate the cost savings for all low-emetic risk chemotherapies in a year

All patients with breast cancer received either four courses of FEC therapy  (500 mg/m² 5-fluorouracil, 100 mg/m² epirubicin, and 500 mg/m² cyclophosphamide) or EC therapy (100 mg/m² epirubicin and 600 mg/m² cyclophosphamide, every 21 days) followed by adjuvant docetaxel therapy (70–75 mg/m²) every 21 days for four cycles.

Before implementation of the institutional antiemetic guidelines, group one (41 patients, 151 courses) received 4 mg ondansetron plus 8 mg IV dexamethasone 30 minutes before treatment with docetaxel.

After implementation of the guidelines, group two (56 patients, 205 courses) received 12 mg dexamethasone only. In both groups, 4 mg oral dexamethasone was given twice a day on days 2 and 3 of docetaxel therapy for prevention of docetaxel-related fluid retention.

Effectiveness and adverse effects were compared between groups. With patients who received dexamethasone and ondansetron, investigators evaluated incidence of nausea, vomiting, and adverse reactions with docetaxel retrospectively in the medical records. 

Additionally, a cost minimization analysis was performed to assess the economic impact of implementing institutional antiemetic guidelines. The cost comparison looked at 4 mg ondansetron + 8 mg dexamethasone + 100 ml normal saline versus 12 mg dexamethasone + 100 ml normal saline plus the time to prepare the antiemetic guidelines, attending committee, and change order sets.

• The study reported on 97 patients (41 in group one and 56 in group two).
• The mean age in group one was 50.2 years (SD = 11.6 groups). The mean age in group two was 50.8 years (SD = 8.9 years).
• The percentage of males and females was not indicated.
• All patients were diagnosed with breast cancer.
• No significant characteristic differences were observed between the groups before or after implementation of the institutional guidelines.

This study was conducted at a single site, the National Hospital Organization Kyushu Cancer Center (NKCC) in Fukuoka, Japan.

All patients were in active treatment. This study has applications for late effects and treatment.

This was a retrospective cohort study.

The Common Terminology Criteria for Adverse Events, version 3.0, was used to grade adverse drug reactions.

• Overall, 97 patients were observed during 356 treatments either before or after implementation of the institutional guidelines (ondansetron + 8 mg dexamethasone versus 12 mg dexamethasone alone).
• Nausea (19.5% in group one versus 16.1% in group two) and vomiting (2.4% in group one versus 0% in group two) occurred in both groups; however, no significant differences in the incidence of emesis were found between the two groups.
• Although anticipated to be higher in the dexamethasone group, no differences were found between the groups in incidence of constipation (34.1% in group one versus 30.4% in group two) or insomnia (17.1% in group one versus 17.9% in group two).
• The cost of ondansetron + 8 mg dexamethasone ($68) decreased to $7.50 with 12 mg dexamethasone.
• Considerable savings occurred between the two groups when ondansetron was eliminated from the low risk antiemetic guidelines.

Dexamethasone alone (12 mg) appeared to be as effective in preventing nausea and vomiting as ondansetron and dexamethasone (8 mg) in low-risk emetic chemotherapy with docetaxel, and it was more cost effective.

• This was not a prospective, randomized, or blinded study
• Outcomes were only evaluated with adjuvant docetaxel therapy for patients with breast cancer and not with other low-emetic risk drugs.
• Adverse reactions caused from the antiemetics were evaluated from medical records.
• Whether 12 mg of dexamethasone is optimal could not be determined from the study.

The use of 12 mg dexamethasone alone for low-risk ematogenic antineoplastic therapies such as docetaxel is recommended in the literature, has shown reasonable effectiveness for preventing nausea and vomiting, and is economically advantageous.

To investigate whether polaprezinc is effective in preventing oral mucositis (OM) in patients receiving high-dose chemotherapy and radiation followed by hematopoietic stem cell transplantation (HSCT)

The treatment group received polaprezinc alginate (P-AG) solution rinses four times per day for one month after transplantation. The control group received an azulene oral rinse four times per day for one month after transplantation.

• N = 36 (25 treatment, and 11 control)   
• AGE RANGE = 15–66 years
• MALES: 40% (treatment); 64% (control); 47% (overall), FEMALES: 60% (treatment); 36% (control); 53% (overall)
• KEY DISEASE CHARACTERISTICS: Hematologic malignancies

• SITE: Single site    
• SETTING TYPE: Multiple settings    
• LOCATION: Medium-sized university hospital in Japan

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Pediatrics and elder care  

Retrospective study

• National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)
• The amount of analgesia used was recorded.  
• Parametric and nonparametric statistics (T test, chi-square, Mann-Whitney, and P value of < 0.05 for significance)

P-AG decreased the incidence of grade 2 or greater OM. The average grade of OM was lower in the P-AG group. There was a decrease in the amount of moderate to severe pain.

P-AG might be effective in lowering the incidence and severity of OM in patients receiving high-dose chemotherapy and radiation followed by HSCT.

• Small sample (< 30)
• Small sample (< 100)
• Baseline sample/group differences of import
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Findings not generalizable

P-AG may help in the prevention of OM, but additional study is warranted before a practice change is recommended.

To investigate the effect of a deep breathing intervention, incorporated within conventional nursing care, on tension-anxiety and fatigue experienced by Japanese women with gynecologic cancer undergoing adjuvant chemotherapy for the first time.

To reduce tension-anxiety and fatigue through deep breathing that incorporated elements of exercise.

The deep breathing intervention was initiated for patients in the intervention group. Each patient received 15 minutes of guidance from the researcher using a DVD and pamphlets. The intervention was performed with nursing assistance pre- and postchemotherapy, with the latter given on the second, fourth, and sixth days. The control group received treatment with the usual chemotherapy and nursing care.

• The study was comprised of 23 women.
• Mean age was 53.6 years (standard deviation [SD] = 9.4 years) in the intervention group and 61.7 years (SD = 9.8 years) in the control group.
• All patients were diagnosed with gynecologic cancers, including uterine (54.5%), ovarian, cervical, and peritoneal carcinomatosis. Cancer stage ranged from I (54.5%) to III.
• Patients were included in the study if they had a recent diagnosis, were postoperative and receiving their first administration of adjuvant chemotherapy, were literate in Japanese, and were willing to participate.
• Patients were excluded if they were younger than 20 years and had received recent psychological treatment (including medication and psychotherapy) and/or recent asthma treatment.

• Single site
• Inpatient
• Osaka, Japan

• Patients were undergoing the active treatment phase of care.
• The study has clinical applicability for late effects and survivorship.

The study used a randomized, controlled trial design.

• Profile of Mood States (POMS)–Short Form (Japanese version):  tension-anxiety and fatigue subscales assessed pre- and posttherapy
• Cancer Fatigue Scale (CFS), subscales of subjective fatigue:  physical, affective, and cognitive assessed pre- and posttherapy

There were no statistically significant differences between groups in terms of age, diagnosis, or cancer clinical stage or treatment type (p > 0.05). Prechemotherapy data showed no significant differences between the intervention and control groups in the previously mentioned measurement tools. The postchemotherapy tension-anxiety scores were lower in the intervention group (p = 0.01). Both groups showed significant reductions in tension-anxiety scores (both p = 0.00). The postchemotherapy physical and total fatigue scores of the intervention group were significantly lower than those of the control group (physical, p = 0.04; total, p = 0.04).

The study demonstrated that the tension-anxiety and fatigue scores of patients undergoing chemotherapy for gynecologic cancers were lowered when the nurses assisted them with deep breathing for a short period in addition to providing conventional nursing care provided pre- and postchemotherapy. The prominent features of the study were that it used a program that combined three deep breathing techniques and was of short duration (10 minutes).

• The study had a small sample size, with less than 30 patients.
• The nurse-to-patient ratio for teaching was 1:1.
• The study was limited to patients with gynecologic cancer and had a limited time period evaluated for fatigue (fatigue can worsen as chemotherapy continues). 
• The study needs to be reproducible in different facilities and with a larger sample size. 
• The study lacked an attentional control.

These are very simple exercises that can be taught to patients and be performed even while they are receiving chemotherapy. In addition to usual nursing care, nurses can contribute to reducing patients’ tension-anxiety and fatigue by assisting them in performing deep breathing.

To determine the efficacy of sennoside-based regimens on the proportion of total days with at least one bowel movement (BM) per day.

During phase I, the first 30 consecutive eligible patients admitted to the ward received docusate plus sennosides (DS) for management of constipation. Dosing was as follows.

• Opioid-naive patients received docusate sodium 200 mg BID.
• For those on opioids or had no BM in 48 hours, the starting dose or next dose was docusate 200 mg BID plus sennosides 17.2 mg every bedtime.
• If patients had no BM in the next 48 hours, they received docusate sodium 200 mg TID plus sennosides 17.2 mg BID.
• If patients had no BM in the next 24 hours, they received docusate sodium 200 mg TID plus sennosides 17.2 mg TID.
• If patients still had no BM after 24 hours, they received docusate sodium 200 mg TID plus sennosides 25.8 mg TID. 

During phase II, the next 30 eligible patients with constipation received sennosides only. Dosing was as follows.

• Patients received sennosides 17.2 mg every bedtime.
• For those on opioids or had no BM in 48 hours, the starting dose or next dose was sennosides 17.2 mg BID.
• If patients had no BM in the next 24 hours, they received sennosides 17.2 mg TID.
• Finally, if patients had no BM after 24 hours, they received sennosides 25.8 mg TID.

Rescue laxatives included lactulose, a suppository, or enema as needed. Only 12 days of bowel protocol were abstracted from the medical record.

• The study reported on a sample of 60 patients.
• Mean patient age was 59.1 years (SD = 14.8, range 24–87) in the DS group and 62.9 years (SD =13.9, range 25–85) in the sennosides group.
• The sample comprised 45 women and 15 men.
• Fourteen patients in the sennosides group had genitourinary cancer, and seven patients in the DS group had breast cancer. 
• Eighty percent of patients were on opioids and 72% were admitted for symptom control.

• Single site
• Inpatient
• Vancouver Center of British Columbia Cancer Agency in Canada

• Patients were undergoing the active treatment phase of care.
• The study has clinical applicability to end-of-life and palliative care.

This was a nonrandomized, nonblinded, sequential cohort study.

Nursing chart review

• The mean study observation period was eight days (range 5–12 days).
• Eighty percent of patients in the sennosides group had a BM on at least 40% of days compared with 60% of the DS group (p = 0.09). However, if patients not taking opioids were excluded, the sennosides group had better results (76% versus 50% of days) than the DS group (not significant).
• Fifty-seven percent of patients in the DS group required additional interventions (lactulose, suppositories, or enemas) compared to 40% in the sennosides group.
• Twenty-seven percent of patients in the sennosides group reported diarrhea compared to 13% in the DS group.

Sennosides only produced more BMs than DS.

• The study had a small sample size (fewer than 100).
• The design was not randomized.
• More patients with genitourinary cancer were recruited in the sennosides group than the DS group, and 90% of patients in the DS group were receiving opioids; therefore, an even comparison in diagnosis was not reflected.
• The dosage of sennosides was higher overall in the sennosides group than the DS group, which could have influenced the results as well.
• Conclusions were based on a chart review, which was performed to look at side effects, versus interview. Data may have been lost if patients were not asked or side effects were not recorded.

Adding a stool softener such as docusate does not necessarily produce superior results than those seen with a laxative alone. However, additional randomized, double-blind studies should be conducted before conclusions and evidence into practice are drawn. The usefulness of this study is questionable because of its design and execution issues.

To determine if honey swished, held, and swallowed reduced the severity of radiation-induced oral mucositis (ROM)

Honey and placebo gel were provided in 5 mL packets to be taken after salt/bicarbonate oral rinses four times a day after meals and after radiotherapy or approximately the same time on non-treatment days. Participants were to pour the product into their mouth, circulate it for 30 seconds, and swallow. Subjects were instructed not to eat, drink, or rinse their mouth for 30 minutes following swallowing the honey or placebo. Treatment started on the first day of radiation and continued for seven days following the last radiation treatment. Visits to the oral oncology/dentistry department were scheduled weekly until mucositis was resolved. During each visit, an oral examination was done for mucositis severity rating, a brief questionnaire was conducted, and weight was obtained. Unused treatment medication was collected at the last visit to measure compliance.

• N = 81  
• MEAN AGE: Honey arm: 56.8 years, placebo arm: 59.5 years
• MALES: Honey arm: 81%, placebo arm: 84%; FEMALES: Honey arm: 19%, placebo arm: 16%
• KEY DISEASE CHARACTERISTICS: Head and neck cancer—hypopharynx, larynx, nasopharynx, oral cavity, oropharynx
• OTHER KEY SAMPLE CHARACTERISTICS: Radiation therapy of ≥ 50 Gy; 62% had concurrent chemotherapy; Caucasian

• SITE: Multi-site 
• SETTING TYPE: Outpatient 
• LOCATION: Vancouver and Sudbury, Canada

• PHASE OF CARE: Active antitumor treatment

• Double-blind, randomized, placebo-controlled, investigator-initiated

• Sialometry and mucositis severity scales from the Radiation Therapy Oncology Group (RTOG)
• World Health Organization (WHO) Oral Mucositis Scale

There were no differences found between the treatment and placebo arms for any of the three outcome assessment scales of mucositis for quality of life, symptom scores, or sialometry. Both the honey (35%) and placebo (43%) groups had lower than expected rates of ≥ grade 3 mucositis.

The honey, when used as directed in this study, did not significantly decrease the severity of ROM. The treatment and placebo groups were well matched, and the blinding was effective. The dropout rate was high (honey: 57%, placebo: 52%, those receiving concurrent chemotherapy: 59%). Most of the dropouts were related to nausea. Patients receiving radiation only had a dropout rate of 48%. Only 48 patients had complete weekly mucositis assessments.

• Small sample (< 100)
• Subject withdrawals ≥ 10%
• Other limitations/explanation: The initial plan for the study was to enroll 180 subjects. The study was terminated at planned interim analysis when 106 patients had been recruited.

There have been varied outcomes in studies of honey for the treatment of mucositis. Differences in methodology could explain at least part of the variability. In this study, the subjects tolerated the honey poorly because of nausea and gagging, and a couple patients experienced a burning sensation. The authors referenced a study from New Zealand in which a honey mouthwash was used because undiluted honey caused extreme nausea, vomiting, and stinging sensations. Potential reasons for the lack of efficacy seen could be that the mucositis tools may not have had adequate sensitivity to reveal any clinical difference between or the osmotic effect of the honey and placebo. Also, Christian areas like Canada, New Zealand, and Great Britain, where honey does not have any special significance, may differ from Muslim areas that have the Koran’s references to honey’s healing powers.