Researchers studied the long-term efficacy of stellate ganglion block (SGB) treatment in reducing hot flashes (HF) and improving sleep disturbances in breast cancer survivors.  

Female breast cancer survivors who were experiencing HF and sleep disturbances were enrolled to undergo SGB treatment. A pilot study was conducted on nine patients before the main study enrolled 25 patients for the SGB treatment. In the pilot study, patient assessments occurred at baseline (one week before SGB) and four weeks after treatment. In the main study, patients were assessed at baseline and at weeks 1, 4, 12, and 24 after treatment.

• The pilot study enrolled nine women, and the main study enrolled 25.
• Median age was 53 years (range 34–69).
• Patients were included if they
  • Were women
  • Had nonrecurrent, early stage, postmenopausal breast cancer diagnosed more than five years prior
  • Had a Karnofsky Performance Scale score (KPS) greater than 80%
  • Had severe treatment-resistant HF.
• Patients were excluded if they had a change of antihormonal therapy for breast cancer within eight weeks of the first SGB, blood clotting disorders, use of anticoagulatants (other than low-dose aspirin), any acute infections, cardiac disorders, and an American Society of Anesthesiologists (ASA) classification score greater than three, as determined by an anesthetist.
• Previous use of systemic therapy for climacteric symptoms was recorded, but simultaneous use of these agents was not allowed.

• Single site   
• Outpatient
• University Hospital, Leuven, Belgium

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

This was a prospective, single-arm, nonrandomized trial.

The Climacteric Symptom Form, HF diary, and Pittsburgh Sleep Quality Index (PSQI) were used to assess the efficacy of SGB on HF and sleep quality. 

This study was divided into two parts:  a pilot study of nine patients and the main study of 25 patients. All patients completed the treatment intervention (SGB) and the assessment to week 24.

• Pilot study:  Five of nine patients had a unilateral SCB; the remaining four had the block bilaterally. Three patients reported no change in HF or sleep quality. Six reported improvement in either the severity of their HF or in sleep quality. All patients required a bilateral SGB to maintain the improvement. 
• Main study: This study showed a decrease in the HF score of 64% (95% confidence interval [CI] [49, 74]) at week 1 and 47% at week 24 (95% CI [27, 62]). The odds ratio for improved sleep quality at week 24 compared with baseline was 4.26 (95% CI [1.86, 9.77]). Thus, SGB seemed to maintain its positive effect on sleep quality over time.

SGB appears to be effective in reducing the number of HF and improving sleep quality in women with early stage breast cancer who are experiencing HF and are resistant to other therapies. The HF gradually returned over time, whereas the improvement in the sleep quality was maintained over 24 weeks. The study demonstrated excellent patient compliance and noted very few side effects other than treatment-induced Horner’s syndrome (ptosis, miosis, anhidrosis, and enophthalmos) that lasted less than six hours.

• The study lacked an appropriate control group.
• The study had a small sample size. The article contains both the data from the pilot study of nine patients and the main study of 25 patients.
• Terminology used in this article was difficult to interpret, and statistical applications for results were confusing.
• There was no consistency to performing a unilateral versus bilateral SGB or to the timing of the second SBG.

The treatment was reported to be safe and very well tolerated, and the side effects were minimal. Further investigation is warranted to identify feasibility in community practices as well as further identification of the appropriate patient population for this intervention.

To test the analgesic effect of CAM2028 with benzydamine compared with CAM2028 without benzydamine (the FDA-approved prescription formula of episil) over an eight-hour period. During treatment with CAM2028, phospholipid and triglceride lipid components self-assemble with a volume of water (saliva) to form a bioadhesive and protective liquid crystalline lining of the oral mucosa. Additional objective of the study was to assess the safety and tolerability of a single-dose of the combined formulation.

1. All patients were receiving radical or postoperative radiotherapy to a significant part of clinically visible oral and/or pharyngeal mucosa at two or more anatomic sites.
2. Trial began during weeks 3 to 4 of radiotherapy and took place over a maximum duration of 12 days.
3. Treatment randomly was assigned after a radiotherapy treatment period of seven days.
4. Patients must have received at least one third of the planned total dosage of radiation.
5. At screening, participants were required to exhibit symptomatic oral mucositis (WHO grade 2 or above). 
6. Likert score of at least 6 was required at screening and before each treatment.
7. Patients were treated with randomized study medication on treatment days 1 and 3 and returned for a final follow-up evaluation on day 5.
8. At the first treatment visit, each patient was randomly allocated to one of two sequences: CAM2028-benzydamine on day 1 followed by CAM20208-control on day 3 or CAM2028-control followed by CAM2028-benzydamine.
9. Patients were assigned a random number and received trial medication sent from the study coordinating center with the corresponding number.
10. List of random numbers was generated at the coordinating center using the permuted bloc method.
11. Treatment allocation was concealed from the investigators, staff at the trial sites, trial monitors, data analysts, managers, and the patients.
12. Patients were given the trial medication after undergoing radiotherapy.
13. One milliliter of the medication was applied to the oral mucosa using a syringe, and patients were instructed to swirl the medication around in the mouth for approximately 15 seconds and then spit. Procedure was repeated after five minutes.
14. On each treatment day, oromucosal pain was assessed by the patient using the Likert scale, done before dosing and at 5 and 30 minutes, and one, two, three, six, and eight hours post dose.

• N = 38 participated (All completed the trial, and no patients discontinued.)
• MEDIAN AGE = 52 years (range = 2–72 years)
• MALES: 84.2%, FEMALES: 15.8%
• KEY DISEASE CHARACTERISTICS: Newly diagnosed head and neck cancer

• SITE: Five oncology centers
• LOCATION: Bulgaria

• PHASE OF CARE: Treatment
• APPLICATIONS: Mucositis

Crossover, double-blind, placebo-controlled, single-dose, randomized, proof of concept trial

• World Health Organization (WHO) 5 grade toxicity scale for oral mucositis
• Likert scale of 0 to 10 for pain

All patients completed the trial. With both treatments, patients experienced a mean 40% decrease in pain intensity at six hours. Both treatments resulted in significant pain relief within five minutes of application that was evident during the entire eight-hour assessment period. At no time did mean pain ratings or pain intensity difference differ statistically between the two treatments. The mean AUC of pain intensity over time did not differ between the two treatments. All of the analyses of pain intensity outcomes showed a statistically significant clinical center effect, with one center reporting larger pain intensity difference values than others. No reason was offered for this difference.

The similar treatment effects of CAM2028 with or without benzydamine suggest that benzydamine did not contribute additionally to the reduction of oral mucositis pain compared with the unmedicated CAM2028 control. CAM2028 resulted in immediate and significant pain relief with a duration that was maintained for up to eight hours.

• Small sample (< 100), split between five centers, and no mention of how many at each center
• No mention of how the outcome assessor was trained to do the assessments of the mucositis, or who did the assessment
• Women were over-represented in the group receiving placebo first.
• One center reported larger pain intensity difference than the others. No reason was offered for this difference.

• Results differences between centers needed further evaluation.
• No patients received chemotherapy in this study, so only applicable to radiotherapy treatment.
• No mention of whether radiation techniques were different between the centers.
• Study does not tell us who monitored the application of the medications.
• CAM2028 may not be a suitable vehicle with which to combine benzydamine.
• Other formulations for extended delivery of benzydamine need to be investigated and studied.

PHASE OF CARE: Multiple phases of care
 
APPLICATIONS: Elder care

The studies included 11 quantitative and one qualitative study. Their findings showed positive effects on sleep in two studies, one of which was a single-arm, nonrandomized study. Positive effects were shown on anxiety in three studies, one of which was single-arm. Four studies showed positive effects on depression, one of which was single-arm. Five studies did not show acupuncture to have any effects. It was noted that acupuncture methodology was inconsistently reported. There also was a lack of data such as standard deviations and change scores.

This review showed mixed results for the effects of acupuncture on sleep, depression, and anxiety. The current evidence has several study design and reporting limitations.

• There was inconsistent reporting of methods and statistical results.
• There was no quality evaluation of individual studies.
• No information was provided regarding whether baseline anxiety or depression scores were clinically significant.
• In many trials, the practitioner delivering the intervention was not reported.

There is no strong evidence to support the use of acupuncture for the treatment of anxiety, depression, or sleep disturbances.

To determine if decision-making support (called decision navigation) was feasible, acceptable, and effective among patients newly diagnosed with prostate cancer with the aim of evaluating confidence in making treatment decisions, certainty in decisions made, and changes in mood and adjustment

Decision navigation involved two primary components, a list of questions to support the question and answer process and audio recordings and summaries to improve information recall.

• N = 113  
• MEAN AGE = 67.2 years (control), 65.4 years (intervention
• MALES: 100%   
• KEY DISEASE CHARACTERISTICS: Inclusion criteria were early-stage, newly diagnosed primary prostate cancer, pending cancer management decision, and referral to a urology specialist for consultation.
• OTHER KEY SAMPLE CHARACTERISTICS: All participants were Caucasian males. There were no significant differences between the control and intervention group.

• SITE: Single site    
• SETTING TYPE: Outpatient    
• LOCATION: Western General Hospital in Edinburgh, Scotland

• PHASE OF CARE: Diagnostic
• APPLICATIONS: Elder care  

Randomized, controlled trial

1. Baseline demographics survey for age, education, employment, living arrangements, and ethnicity
2. Decisional Self-Efficacy (DSE) is an 11-item scale that measures confidence in decisions. It was administered at baseline, after the consultation planning appointment, after the consultation, and after six months. 
3. Decisional Conflict Scale (DCS) is a measure of certainty about decisions. It was administered after the consultation and after six months. 
4. Decision regret (RS) was measured at six months.
5. Mental Adjustment to Cancer Scale (MAC) has subscales that measure fighting spirit or hopelessness-helplessness, anxiety, and fatalism. It was administered at baseline and six months after consultation. 
6. Hospital Anxiety and Depression Scale (HADS) was administered at baseline and six months after the consultation. 
7. Decision Preparation Measure (DPM), a five-item rating scale, was administered after the consultation planning appointment and after six months to evaluate the use of the intervention and to confirm final treatment choice. 

The intervention was not shown to have an impact on anxiety or depression symptom scores.

• Risk of bias (no blinding)
• Findings not generalizable
• Intervention expensive, impractical, or training needs
• Subject withdrawals ≥ 10%  
• Other limitations/explanation: Although the sample size was 113 participants, only 53 were in the control group and 62 were in the intervention group (less than 100 in each group), limiting this study's generalizability. There are training needs regarding the specific and individualized list of questions provided in anticipation of the consultation. It is possible that the physicians could become accustomed to the questions on the list, therefore increasing the amount of information given to the patient without interaction? Ninety-nine patients refused to participate in the study, and 10 patients withdrew.

Dedicated decision support for patients preparing for treatment consultation involves patients, increases confidence in asking questions during the consultation, and increases certainty about decisions made. Research to evaluate the effectiveness and cost reduction potential of DN for people with other cancer diagnoses is important. Although decision support interventions are essential to assist patients in decision making, these approaches alone may not be sufficient to manage symptoms of depression and anxiety.

To examine the effects of exercise with proprioceptive neuromuscular facilitation (PNF) on depression and anxiety in women with postmastectomy lymphedema

Subjects performed the exercises for 30 minutes, three times weekly, for 16 weeks. Subjects were divided into three groups, a PNF plus super lizer group (which received light radiation as well), a PNF plus manual lymphatic drainage (MLD) group, and a PNF alone group. All groups received the same exercises. Study measures were obtained every four weeks.

• N = 52  
• MEAN AGE 52.5 years
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Patients were selected from those who showed lymphedema following mastectomy.

• SITE: Single-site    
• LOCATION: Republic of Korea

Three-group trial with a repeated-measures design

• Beck Depression Inventory (BDI)
• Beck Anxiety Inventory (BAI)

Although there was a group-by-time interaction effect on the results, depression scores declined significantly in all groups with no significant difference between the groups after 16 weeks. Anxiety scores also declined in all groups with no differences between them. At the end of the study, scores were lowest in the PNF plus MLD group. Scores declined more in this group over time.

The findings of this study are inconclusive regarding the impact of PNF exercise on depression and anxiety in women with lymphedema following a mastectomy.

• Small sample (< 100)
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment) 
• Measurement validity/reliability questionable
• Other limitations/explanation: Repeated-measures design has inherent testing potential as a threat to validity

Exercise and MLD have previously been shown to be of benefit for women with lymphedema, and exercise has been shown to be beneficial in terms of reducing anxiety and depression in patients with cancer. It is not clear whether the specific PNF technique in exercise has any greater benefit. This study had several design limitations.

To describe the underlying mechanisms, clinical presentation, severity grading (according to National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], version 4.0), and strategies to prevent and manage epidermal growth factor receptor inhibitor (EGFRI)-associated skin side effects, emphasizing evidence-based practice.

The type of patients addressed was adults receiving an EGFRI, including monoclonal antibodies (e.g., cetuximab, panitumumab) and tyrosine kinase inhibitors (e.g., erlotinib, gefitinib, lapatinib).

In this expert opinion article, a panel of German dermatologists met in June 2009 in Frankfurt am Main, Germany, to generate mutual recommendations on the management of cutaneous side effects of EGFRIs. Those recommendations were passed after an internal revision in July 2010. The authors stated the basis of the recommendations was the physicians’ long-term personal experiences with affected patients.

Databases searched were not reported.

Search keywords were EGFR, cutaneous side effects, and papulopustular exanthema.

Studies were included in the review if they were published up to April 2010.

Exclusion criteria were not reported.

Patients were undergoing the active treatment phase of care.

General and Preventive Measures for All Patients Receiving EGFRI Therapy:

• Give patient education regarding various cutaneous side effects, usual time points for manifestation, and positive correlation between early occurring papulopustular exanthems and therapy success and general measures. 
• The following advice was recommended for preventive skin care procedures for all patients receiving therapy with EGFRIs:
  • Avoid frequent hand washing; daily, long showers; or frequent, long baths.
  • Use mild bath or shower oils or syndets (no soap).
  • Use moisturizers or urea-containing skin care products (e.g., ointment, cream) without fragrances or other skin irritants (no lotion or gel).
  • Avoid sun-tanning parlors, and consistently use sun protection products (light exposure factor > 20) or clothing protection from ultraviolet radiation.
  • Avoid skin contact with irritants such as solvents, disinfectants, and polishes.
  • Avoid activities that mechanically stress the skin (e.g., garden work, carrying heavy objects, hot hair drying).
  • For adequate treatment of preexisting skin diseases, refer to a dermatologist.

Medicinal Prophylaxis of EGFRI Cutaneous Lesions:

• A few studies on medicinal prophylaxis of papulopustular exanthema have been performed, and their results do not allow for reliable recommendations.
• Prophylactic treatments included oral tetracycline, minocycline, and doxycycline; topical pimecrolimus; skin moisturizer; and topical sunscreen, glucocorticosteroids, and vitamin K3.

Therapy of the Papulopustular Exanthems on the Face and Trunk:

• Initiate combined therapy with a topical metronidazole or nadifloxacin-containing ointment and a systemic tetracycline (doxycycline: 50 or 100 mg BID;  minocycline: 50 mg BID; tetracycline: 2–4 x 250 mg daily).
• Treatment of rash with wound gel containing collagen or lidocaine and topical vitamin K3 is being studied.

Advanced Diagnostics and Therapy for Rash (Usually With a Dermatologist):

• Obtain microbial diagnostics in papulopustular exanthema.
• If Demodex mites are detected in the lesions, employ topical metronidazole, a short course of an azelaic acid cream, or a cream containing permethrin.
• If Pityrosporum yeasts are identified, ciclopirox olamine, clotrimazole, or ketoconazole is recommended.
• In bacterial superinfection, depending on the antibiogram (usually identification of Staphylococcus aureus), topical therapy with an antiseptic agent (e.g., octenidine) and targeted systemic antibiotic therapy are recommended.
• For eczematous skin lesions with scaling and pruritus on the trunk, mild-to-moderate potency topical glucocorticosteroids (e.g., hydrocortisone butyrate, methylprednisolone aceponate) are recommended.
• When clinical features of seborrheic dermatitis or perioral dermatitis are present in the face, pimecrolimus or tacrolimus and a topical antifungal agent (e.g., ciclopirox) may be used.

Therapy of Papulopustular Exanthems on the Scalp:

• Early treatment with a systemic antibiotic usually offers effective protection from the development of a severe papulopustular rash on the scalp.
• In patients who develop a superinfection despite administration of a systemic antibiotic, microbiological diagnostics should be performed and therapy based on the antibiogram should be changed to an antibiotic effective against S. aureus (e.g., flucloxacillin).
• Antimicrobial shampoos may be used.

Treatment Recommendations: Dry Skin and Pruritus:

• Use of emollients (e.g., urea-containing products), perhaps with the addition of an antiseptic (e.g., triclosan) can be used for dry, sensitive skin.  
• If marked inflammation exists, a short course of glucocorticosteroid ointment is recommended.
• If severe inflammation exists, a short course of glucocorticosteroid ointment and an antiseptic is recommended.
• Topical products containing polidocanol and oral antihistamines can be used on a supplemental basis for dry skin and pruritus.
• If inflamed skin fissures exist, obtain a referral to a dermatologist.

Treatment Recommendations: Paronychia:

• In early stages of paronychia, treatment with a topical antifungal agent (e.g., ciclopirox olamine) and a topical antibiotic (fusidic acid) is recommended.
• In the event of damage to the cuticle, a nail lacquer containing ciclopirox should be applied every two days.
• Combination of a topical glucocorticosteroid and a disinfectant can be considered.
• Systemic therapy can include one of the oral tetracyclines, or an oral cephalosporin or quinolone.
• In advanced or persistent inflammation, the patient should be referred to a dermatologist for further treatment.
• For severe inflammation, microbiological tests and targeted antibiotic therapy are recommended.
• Excessive granulation tissue should be removed surgically or with silver nitrate.
   

Effective management of frequent cutaneous side effects is important for tumor therapy. The present recommendations developed by a German expert panel are based on a three-step concept.

• Patient education and general preventive measures
• Measures that should be initiated as early as possible by the primary treating physician at the first sign of skin lesions
• Advanced diagnostics and therapy by a specialized dermatologist

Although the article had 36 references, several interventions (especially in rash—advanced diagnostics and therapy, rash—therapy on scalp, measures for dry skin and pruritus, and therapy of paronychias) do not have a specific reference.

Adequate management of cutaneous side effects is necessary for optimal therapeutic benefit and enhanced quality of life. Because of their visibility, cutaneous side effects are experienced by many patients as a psychological burden that can impair quality of life and often endangers compliance with therapy, or leads to a dose reduction or discontinuation. This article provided nurses with practical recommendations for the prevention and management of cutaneous side effects of EGFRIs.  

The purpose of the article is to assess the influence of colony-stimulating factors (CSFs) on the prevention and treatment of infectious complications in patients with acute myelogenous leukemia (AML).

The Cochrane Central Register of Controlled Trials, MEDLINE (January 1966 to July 2010), and LILACS (through December 2009) databases were searched, as were ongoing trials and conference proceedings from January 2002 to June 2010 from the European Group for Bone and Marrow Transplantation, the Annual Meeting of the European Hematology Association, the Annual Meeting of the Society for Hematology and Stem Cells, and the Center for International Blood and Marrow Transplant Research (CIBMTR).

Articles included in this review were randomized, controlled trials that compared the addition of CSFs during and following chemotherapy to chemotherapy alone in patients with AML and included age, type of AML (morphology criteria according to the FAB classification), leukemia type (de novo AML, secondary AML, refractory AML, relapsed AML), white blood cell count, platelet count, and treatment stage (induction, consolidation, relapse).

Articles were excluded if they were reporting on trials evaluating the role of CSFs administered for the purpose of stem cell collection and/or priming (e.g., before and/or only for the duration of chemotherapy).

1,421 total references were retrieved.

Following a review of each study by two reviewers, statistical analyses were conducted including relative risk with a 95% confidence interval (CI) for dichotomous data and hazard ratios for time-to-event outcome. Cochrane handbook criteria were used to assess study quality.

• 19 studies were included in the final review.
• The total sample size of the combined studies was 5,256.
• The sample size across studies ranged from 53–803.
• The patient population was diagnosed with AML (per World Health Organization 2008 classification), were at any stage of treatment following chemotherapy, and were of all ages.
• The ages varied per study with one pediatric study including patients younger than 16 years old (Nakajima) and another (Lehrnbecher) aged 0–18. Four studies contained patients aged 15–60, six contained patients older than age 55, and eight had patients older than age 15.
• Chemotherapy regimens also varied and included numerous agents used as induction, consolidation, or salvage therapy, or conditioning regimens for HCT.
• All patients in the intervention arms of the studies evaluated received CSF (G-CSF or GM-CSF), IV or subcutaneous, started with or following chemotherapy.
• Those receiving CSF as part of the HCT cell collection or conditioning were excluded.
   

Active treatment

No statistically significant differences were found between patients who received CSF with chemotherapy compared to those who did not. This included no differences in 30 day all-cause mortality (RR = 0.97; 95% CI [0.8, 1.18]) and end of follow-up (RR = 1.01; 95% CI [0.98, 1.05]), overall survival (HR = 1.00; 95% CI [0.93, 1.08]), complete remission (RR = 1.03; 95% CI [0.99, 1.07]), relapse (RR = 0.97; 95% CI [0.89, 1.05]), disease-free survival (HR = 1.00; 95% CI [0.9, 1.13]), decrease in bacteremias (RR = 0.96; 95% CI [0.82, 1.12]) or invasive fungal infections (RR = 1.4; 95% CI [0.9, 2.19]). There was a slight increase in adverse events requiring discontinuation of CSFs in intervention groups compared to controls (RR = 1.33; 95% CI [1.00, 1.56]). Among 17 studies in which duration of neutropenia was reported, in all but one study the duration of neutropenia was significantly shortened with CSFs. Several studies reported a significant shortening of duration of hospital stay with CSFs, while others showed no difference.

Administration of CSFs is associated with decreased episodes of febrile neutropenia and febrile days; however, it shows no statistically significant benefit of being administered with chemotherapy for improved survival and decreased infection rates. Since hematopoiesis is different in pediatric patients compared to adults (occurring in the bone marrow of long bones and at higher rates in pediatric populations, and in flat bones at slower rates in adults and older adults), benefits may be found in older age groups when using CSF with chemotherapy. Among the studies that had a mean age of patients at 58 years and older (n = 7), six of them showed more favorable outcomes in patients who received CSF.

The composite evaluation of all age groups together.

Implications for practice based on this study are unfavorable to use CSF for decreased infection rates among all age groups. Further evaluation in older age groups may be warranted.

To compare the effects of complete decongestive therapy (CDT) with intermittent pneumatic compression (IPC) and self-lymphatic drainage

Patients were randomized to receive either CDT, consisting of manual lymphatic drainage and compression bandaging, or self-lymphatic drainage and pneumatic compression. Both groups did the same exercises and wore compression garments at the end of therapy. Treatments were done every other day for six weeks. IPC was applied for 45 minutes in each treatment.   Patients did self drainage at home daily for 15 minutes during the study. Study measurements were done at the beginning and end of the six-week study period.

• N  = 30            
• MEDIAN AGE = 55
• AGE RANGE = 31–74
• MALES: 0%, FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: All participants had breast cancer and lymphedema at study entry. All had level 1 or 2 axillary lymph node dissection and had radiotherapy to the regional lymphatics. 
• OTHER KEY SAMPLE CHARACTERISTICS: Participants had no prior treatment for lymphedema.

• SITE: Single site        
• SETTING TYPE: Outpatient     
• LOCATION: Turkey

• PHASE OF CARE: Not available

• Randomized, controlled trial

• Diary of self treatments
• European Organisation for Research and Treatment of Cancer–Ouality of Life Core 30 (EOTRC QLQ-C30)
• American Shoulder and Elbow Association Quality of Life questions regarding effective use of the arm during the day
• Stillwell classification for lymphedema
• Arm circumference measurement

Both groups had significant reduction in arm volumes at one, two and six weeks (p < .001). There were no significant differences between the groups in this change. There were no significant differences between groups in other study measures. Quality of life improved significantly across the study in both groups.

There were no significant differences in lymphedema or associated quality of life between patients receiving CDT or IPC plus self lymphatic drainage. Both approaches were effective in reducing arm lymphedema volumes.

• Small sample (< 100) 
• Baseline sample/group differences of import
• Risk of bias (no blinding)
• Key sample group differences that could influence results
• Other limitations/explanation: More patients in the CDT group had total mastectomy. No information is provided as to whether patients were completely finished with adjuvant treatment.

Findings show that both approaches studied were effective in reducing lymphedema and improving QOL over a six-week period. The study is limited by the small sample size and short period of time for follow-up.

The purpose of the study was to evaluate the feasibility and efficacy of G-CSF secondary prophylaxis in patients with solid tumors undergoing chemotherapy.

Patients in the study required IV antibiotics filgrastim 300 mg per day subcutaneously starting 24–30 hours after the last chemotherapy dose in a subsequent cycle. A total of 8–9 alternate day doses were given. If no other dose limiting toxicity was seen, patients received full chemotherapy dosing with filgrastim support for following treatment cycles. Duration of hospital stay, days on antibiotic therapy, incidence of fever, time to resolve fever, dose reductions or delays, neutrophil recovery time, and incidence of adverse events were recorded. Results compared to findings in the same patients during the previous chemotherapy cycle.

• The total sample size was 50.
• Participants had a median age of 47, with a range of 22–75.
• The most common cancer types were lymphoma and breast cancer.
• Fifty-eight percent were receiving adriamycin-containing regimens.
   

Single-site location in India

Active antitumor treatment

Prospective, single group, observational study

No specific measure definitions were provided.

Neutrophil recovery time, duration of fever, duration of antibiotics and duration of hospitalization, cycle delays, and chemotherapy dose reductions declined with each course of chemotherapy. The decrease in all measures was significant across four treatment cycles (p < 0.01).

Study findings provide some support the use of colony-stimulating factor as secondary prophylaxis in patients receiving myelosuppressive chemotherapy. A number of study limitations limit the strength of these findings.

• Small sample (less than 100 participants)
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Measurement/methods not described  
• Measurement validity/reliability questionable
• The stated sample size varies in the report from 54 to 50, and authors stated that two patients who developed overwhelming febrile neutropenia during the study were eliminated from analysis, demonstrating no intent to treat analysis.
• No definition of neutropenia for determination of recovery time is provided.

This study provides limited evidence supporting the use of colony-stimulating factors as secondary prophylaxis in patients receiving chemotherapy. CSF was given every other day in this trial, adding to the body of evidence in which the frequency of administration varies. Secondary prophylaxis can play an important role in sustaining the treatment dosages of chemotherapy cycles.

To test whether oral alpha-lipoic acid (ALA) could reduce the severity of peripheral neuropathy in patients receiving platinum-based chemotherapy

Prior to randomization, patients were stratified according to prior exposure to platinum-based therapy dosages. Patients were assigned to receive ALA 600 mg oral sustained-release tablets three times per day. Control patients received a matching placebo. Medications were taken continuously for 24 weeks between two days prior and four days after each dose of platinum.

• N = 70   
• MEAN AGE = 56 years
• MALES: 53%, FEMALES: 47%
• KEY DISEASE CHARACTERISTICS: Gastrointestinal cancers were most common. Dosage of platinum compounds were in excess of 750 mg/m²​.
• OTHER KEY SAMPLE CHARACTERISTICS: Patients with neuropathy and diabetes mellitus, and those exposed to carboplatin, vincristine, paclitaxel, or docetaxel within the past six months were excluded.

• SITE: Multi-site   
• SETTING TYPE: Outpatient   
• LOCATION: Texas

• PHASE OF CARE: Active antitumor treatment

• Double-blind, placebo-controlled RCT

• FACT/GOG-NTX (version 4) for neuropathic symptoms
• Brief Pain Inventory
• Functional tests—time to button a six-button shirt, 50-foot walk, and coin test

Only 28% in the ALA arm and 30% in the placebo arm completed 24 weeks of the study. Most discontinued the study because of withdrawal of consent and noncompliance. Neuropathy scores increased significantly from baseline in both groups at 24 weeks (p < .001). No differences were observed in study results between groups.  Authors state that attrition was not related to toxicities and that adverse events were comparable between groups.

Findings did not show a beneficial effect of ALA for prevention or reduction of peripheral neuropathy in patients receiving platinum-based chemotherapy.

• Small sample (less than 100)
• Subject withdrawals 10% or greater
• Other limitations/explanation: Extensive attrition, suggesting that the intervention was not acceptable to patients

Findings do not show a benefit of oral ALA for prevention of chemotherapy-induced peripheral neuropathy with platinum-based chemotherapy. Management and prevention of chemotherapy-induced peripheral neuropathy is a challenge that is generally managed by dose reduction or chemotherapy discontinuation, which can reduce effectiveness in treatment of cancer. Few approaches have shown to be effective in preventing or reducing chemotherapy-induced peripheral neuropathy. Ongoing research in this area is needed.