• Participants were assigned randomly to one of three factor-control groups.
• Patients were given a 10-minute foot massage (five minutes per foot) on three consecutive days from 7–8 pm.
• Patients were given slow and firm massage or gentle strokes toward the heart, from the base of the toes up the foot and lower leg to the knee.
• Patients received a short foot massage before study enrollment to reduce the possibility of anticipatory anxiety.

• The study consisted of 87 participants.
• The sample was 60% female and 40% male.
• Patients ranged in age from 18-88 years.
• To be included, patients had to have
  • Been diagnosed with cancer.
  • Been 18 years or older.
  • Reported pain or nausea.
  • Had not received surgery in the last six weeks.
• Primary cancer sites varied, and 32 participants had metastatic disease.

All participants were in the inpatient setting. No further setting description was provided.

• Patients reported symptoms using a 100-mm visual analog scale (VAS) with 0 mm = no nausea, and 100 mm = vomiting or dry retching.
• Heart rate and subjective data were measured at two intervals: before massage and 10–20 minutes after completion of massage.
• On control nights, participants stayed quietly in bed and did a quiet activity with the same measurements.

Evidence suggested that massage reduces feelings of nausea. No significant difference was found between the control session pretest mean nausea score and post-test mean nausea score. In contrast, the mean nausea scores for the massage sessions decreased.

• In session 1, t = 3.117, p = 0.0012, and the mean difference was 6.4 mm.
• In session 2, t = 3.178, p = 0.0011, and the mean difference was 4.9 mm.

• The study did not control for medications, although they were recorded.
• Findings were not correlated with diagnosis, type of cancer, metastases, or treatment schedules.
• The long-term effects of massage are unknown.
• Pain and relaxation were measured as well as nausea and vomiting.

L-carnitine is essential for glucose and lipid turnover and has a role in maintaining energy metabolism.

A high daily fractionated dose ​L-carnitine 2-g solution was given twice daily (BID) for seven days. Ifosfamide and cisplatin cause increased renal excretion and alter the usual enzyme pathways, potentially causing asthenia with impaired energy metabolism.

The study included 50 nonanemic adults with stage IV solid tumors receiving combination chemotherapy, including ifosfamide or cisplatin, with palliative treatment intent.

Not described

The study used a prospective, nonrandomized, single-arm trial, open-label, pre-/posttest design.

Functional Assessment of Cancer Therapy-Fatigue (FACT-F), 13 items with ratings from zero to four

All 50 patients were evaluable; 20 patients had fatigue at the first cycle and 30 had fatigue at the second cycle. L-carnitine levels were greater than 30 μm in 100% of the patients, and it was well tolerated. Fatigue was ameliorated in 90% (n = 45) with L-carnitine (p < 0.001). Of the nonresponders, three patients were stable and two got worse.

• The study had a small sample size.
• The study used a nonrandomized design.
• No comparison group was included.
• L-carnitine depletion may not be the primary cause of fatigue experienced by these patients.
• L-carnitine could be resupplied through diet, which was not monitored.
• Urinary loss of L-carnitine may be asymptomatic.

Cost of supplements and monitoring levels of L-carnitine is unknown.

To assess the effect of providing systematic full access to the medical record on patients’ anxiety, quality of life, and satisfaction

Participants were randomly assigned to either requested access to the medical record or systematic full access groups. In the requested access group, information and the medical record were delivered to the patient at the physician’s or patient’s request. In the systematic access group, patients were given a briefcase that they were to bring to each visit. The briefcase was filled with administrative data as well as reports of surgery, pathology, laboratory, radiology, and hospitalizations and nursing narrative notes. Documents were provided to the patient as well as on CDs, including radiology images. Documents were updated at each visit, and in between visits materials were mailed to the patient. A coordinator provided updated information for the patient to put in the briefcase and explained the material to the patient in a standardized way. Medical and nursing staff also provided information and answered patient questions. Patients completed questionnaires for the study data collection at the beginning of the study and at the end of their first chemotherapy cycle.

• The study reported on a sample of 295 patients.
• Mean patient age was 54.6 ± 12.1.
• The sample was 86.8% female and 31.2% male.
• Newly diagnosed breast cancer, colon cancer, and Hodgkin and non-Hodgkin lymphoma were the most common diagnoses.
• All patients were beginning adjuvant chemotherapy.
• Of the sample, 70.6% were married or cohabiting, 50.2% had secondary or higher level education, and 61.7% were currently employed.

• Multisite
• Outpatient setting
• Cancer center in France

Patients were undergoing the active treatment phase of care.

The study was a randomized controlled trial with repeated measures.

• Spielberger State-Trait Anxiety Inventory
• European Organization for Research and Treatment of Cancer Quality of Life Questionnaire
• Four-point Likert-type scale for satisfaction

Mean anxiety score at baseline was 40.7 in all patients (scores of 20–80 generally indicate a higher level of anxiety). There were no differences at baseline between groups and no change over time in the systematic full access group. There was a significant reduction in anxiety at the end of treatment in the requested access group (p = 0.009), but no differences between study groups. There were no differences between groups in quality-of-life findings. A higher percentage of patients in the full access group were completely satisfied with treatment explanations than in the requested access group; however, the difference between groups was not significant. Full access was not a source of anxiety for 68.8% of patients, and 82.2% said they understood the information.

Provision of full information in an organized medical record provided to patients did not increase patient anxiety, was practical to implement, and may have a positive effect on patient satisfaction with information.

• There was no subgroup analysis of state anxiety findings by anxiety trait findings. 
• The satisfaction measure was a single measure with no established validity or reliability.

This study outlines a practical way to provide full medical record information to patients in a way that was acceptable to them. Findings show that provision of full information did not increase patient anxiety and was associated with a tendency for patients to have more satisfaction with information provision. This may be a useful approach to engage patients in their care. Most of these patients were fairly well-educated, so it is not clear whether these results can be generalized to less educated patients.

To review the effectiveness and safety outcomes of patients selected to receive surgical procedure for lymphedema (LE) after a program of complete decongestive therapy (CDT)

LE therapy consisted of manual lymph drainage, compression bandaging and garments, and vascularized lymph node transfer (VLNT), which was used for upper extremity LE by removing lymph nodes from the groin and transferring them to the affected axilla or along with a deep inferior epigastric perforator (DIEP) flap. Lymphaticovenous anastomosis (LVA) was preferred for lower extremity LE, which was completed by connecting lymphatics to nearby microscopic veins. Both VLNT and LVA are for LE with primarily fluid component. Suction-assisted protein lipectomy (SAPL) is used to treat the solid type of LE and requires continued compression after procedure.

• N = 26
• MEAN AGE = 53 years
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Women with upper extremity LE secondary to breast cancer, congenital lower extremity LE, or lower extremity LE secondary to gynecologic cancer treatment

• SITE: Single-site    
• SETTING TYPE: Inpatient    
• LOCATION: University of California, Los Angeles, United States

• PHASE OF CARE: Transition phase after active treatment
• APPLICATIONS: Elder care, palliative care

Retrospective chart review

• Circumferential limb volume
• Excel database
• Paired T-tests for pre-/postoperative comparisons
• Volume reduction for SAPL at 4 and 12 months after surgery
• Change in compression garment use and lymphedema therapy necessary for VLNT and LVA
• Change in the incidence of cellulitis in all cases

The retrospective chart review of 26 selected patients from one surgeon identifying phases of LE, earlier with fluid component swelling, using VLNT, LVA, or SAPL showed positive results in regard to volume reduction, decreased infection episodes, and decreased garment/CDT requirements.

• Small sample (< 30)
• Baseline sample/group differences of import
• Risk of bias (no control group)
• Selective outcomes reporting
• Key sample group differences that could influence results
• Intervention expensive, impractical, or training needs

Carnitine is a cofactor required for cell energy production that serves as the primary fuel source for heart and skeletal muscles. Cancer-related anorexia/cachexia syndrome (CACS) and oxidative stress (OS) are two prominent features in patients with advanced cancer; therefore, L-carnitine supplementation was tested in patients with advanced cancer. Based on the current knowledge of carnitine use, patients took three doses (2 g) of L-carnitine orally each day for four weeks. Patient outcomes were evaluated at baseline (T0), week two (T1), and week four (T2).

• Twelve patients with locally advanced or metastatic disease were included.
• Mean age was 60 years (range 42–73).
• The majority of patients were women (n = 10) with mixed tumor sites (most common being gynecological cancer), and most were receiving concomitant chemotherapy (n = 10). 
• Patients were excluded if they had an Eastern Cooperative Oncology Group (ECOG) performance status of greater than 2, had insulin-dependent diabetes mellitus, or were pregnant.

Patients were undergoing the active treatment phase of care.

The study was an open-label, nonrandomized trial. 

Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF)

The L-carnitine intervention resulted in improved fatigue outcomes. The observed decline in MFSI-SF fatigue scores was statistically significance at both T1 (p < 0.05) and T2 (p < 0.001) in comparison to the baseline scores. Mean MFSI-SF scores at T0, T1, and T2 were 25.40 (standard deviation [SD] = 13.91), 16.93 (SD = 11.92), and 12.05 (SD = 12.56), respectively. Evaluation of subscales showed a statistically significant difference from T0 to T1 for the General subscale (p < 0.05) and the Physical subscale (p < 0.05).

• The study had a small sample size. 
• The study lacked a neutral comparison group.

To assess the safety and evaluate the efficacy of ​a fixed-dose combination of netupitant and palonosetron (NEPA) over multiple cycles of highly emetogenic chemotherapy (HEC) and moderately emetogenic chemotherapy (MEC)

Oral NEPA (​netupitant [NETU] 300 mg + palonosetron [PALO] 0.50 mg) + dexamethasone (DEX) versus oral aprepitant (APR) (125 mg Day 1; 80 mg Days 2–3) + oral PALO 0.50 mg Day 1 + DEX (for HEC, DEX Days 1–4; for MEC, DEX Day 1 only)

• N = 412  
• AVERAGE AGE = 58 years 
• MALES: 50%, FEMALES: 50%
• KEY DISEASE CHARACTERISTICS: Eligible patients were ≥ 18 years, diagnosed with a malignant tumor, naïve to chemotherapy, and scheduled to receive repeated, consecutive courses of chemotherapy (HEC/MEC). A single intravenous (IV) dose of one or more of the intervention versus control agents was administered on Day 1. Single-day chemotherapy was necessary for inclusion. ECOG ≤ 2.
• OTHER KEY SAMPLE CHARACTERISTICS: Non-AC chemotherapy, no previous NK1RA use, no CYP3A4 inducer use within four weeks, no bone marrow transplant or stem cell rescue therapy, no known hypersensitivity of or contradiction to 5-HT3RA or dexamethasone.

• SITE: Multi-site    
• SETTING TYPE: Outpatient    
• LOCATION: Multinational including Bulgaria, Czech Republic, Germany, Hungary, India, Poland, Russia, Serbia, Ukraine, and the United States

• PHASE OF CARE: Active antitumor treatment

Phase 3 multinational, double-blind, double-dummy, parallel group study design

• Safety: Treatment-emergent adverse events (TEAEs), labs, physical exams, vital signs, ECGs, cardiac troponin I (cTnl), and left ventricular ejection fraction (LVEF)
• Efficacy: Diary (Days 1–6) recorded the onset and duration of emetic episodes and nausea severity (Visual Analog Score [VAS] 0–100). They also recorded the achievement of complete response (CR, no emesis, no rescue medication) or no significant nausea (VAS score of < 25 mm) during the acute (0–24 hour), delayed (25–120 hour), and overall (0–120 hour) phases after the start of chemotherapy.

• Baseline sample/group differences of import
• Subject withdrawals ≥ 10%  
• Other limitations/explanation: Patients participated in up to six cycles (98% completed one cycle, 75% completed four cycles, and 40% completed six cycles). 

To test the effect of prophylactic 3M Cavilon no-sting barrier film (no-sting) on the rates of moist desquamation compared with sorbolene cream (10% glycerin).

The chest wall was divided into medial and lateral halves, with one half treated with no-sting and the other with sorbolene. No-sting was applied by the nursing staff. Administration began at the start of radiation therapy until two weeks after completion. When a moist desquamation occured, the skin care changed to hydrocolloid dressing.

• The study sample (N = 61) was comprised of female patients with breast cancer.
• Mean age was 58 years, with a range of 30–88 years.
• Thirty-seven patients received chemotherapy, 13 concurrently and 24 sequentially.
• Radiation therapy used a 6 MV photon beam at a dosage of 50 Gy applied tangentially in 25 fractions.

The study took place across multiple sites in Sydney, Australia.

The study used a quasi-experimental design with patients as their own control.

• Patients were assessed from week 1–12.
• The Radiation Therapy Oncology Group and European Organisation for Research and Treatment of Cancer skin scoring assessment was done weekly.
• A five-point Likert scale was used to measure pain and pruritus for each area of the skin.

• Skin dosimetry data in the nonbolus area confirmed that no difference was present in the buildup effect (or lack thereof) between sorbolene and no-sting in those areas outside the skin covered with the bolus material.
• For skin reaction score (p = 0.005) and pruritus (p = 0.011) the no-sting scores were less.
• No evidence was found of a statistically significant trend in the relationship to pain scores or analgesia requirements.
• Nine patients required analgesics for skin reaction in the sorbolene group and eight patients in the no-sting.
• The cost and nursing time was relatively the same per patient, but the peak skin reactions occurred several weeks after radiation therapy was completed.
• Two patients in the no-sting group had treatment delays because of pruritus.

No-sting may be beneficial in the mitigation of skin toxicity with radiation therapy.

• The study did not provide a control group without alternative treatment for comparison.
• In longitudinal follow-up at six weeks data analysis, they included cases for which it was stated that no data was available. It was not clear how these were handled.
• Initial cost of the product showed that no-sting was more expensive.
• There was no subgroup analysis based on concurrent chemotherapy.
• The sample size was small given the variability in patient treatment regimens.

A previous unblinded study demonstrated that an alcohol-free barrier film containing an acrylate terpolymer (ATP) was effective in reducing skin reactions compared with a 10% glycerine (sorbolene) cream. The different appearances of these products precluded a blinded comparison. To test the ATP principle in a double-blind manner required use of an alternative cream formulation, a moisturizing durable barrier cream (MDBC). This study tested the hypothesis that an ATP alcohol-free barrier film reduces the degree of radiation skin reaction compared with the 10% glycerine cream most commonly used for this purpose in women receiving postmastectomy radiation therapy in Australia.

The chest wall was divided into medial and lateral compartments, and patients were randomized to receive MDBC applied daily to the medial or lateral side and sorbolene to the other side. Patients were instructed to apply the separate creams daily at the start of radiation to each half of the area on the chest wall receiving radiation therapy and to continue until two weeks after radiation completion. Weekly observations, photographs, and symptom scores (pain and pruritus) were collected until week 12, or resolution of skin reactions if earlier. Skin dose was confirmed by centrally calibrated thermoluminescent dosimeters (TLDs).

• N = 318
• AGE = 26–89 years
• MALES: 0%, FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Patients receiving radiation of at least 45 Gy in 25 fractions after total mastectomy
• OTHER KEY SAMPLE CHARACTERISTICS: Aged 18 years or older, Eastern Cooperative Oncology Group performance status 0–2, ability to consent, ability to attend weekly for up to six weeks after treatment completion. Ineligibility: previous radiation therapy to chest wall, clinically evident cutaneous involvement by malignancy, pregnancy, known allergy to skin  care products

• SITE: Multi-site  
• SETTING TYPE: Not specified  
• LOCATION: 12 radiation treatment centers in Australia

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Elder care 

• Paired, double-blind, randomized comparison

• TLD measurements were performed twice during radiation with two TLDs per skin compartment. TLDs were centrally calibrated.
• Patient outcomes were scored weekly using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 scores.
• Photographic audit of skin scores confirmed the pattern of reactions scored by clinicians.

The MDBC did not reduce peak skin reaction compared to sorbolene. It is possible that this is related to the difference in formulation of the cream compared with film formulation.

• There was no clear consistency on how the cream should be used. Even though it was recommended for daily use, some patients did use it twice a day.

This study emphasizes the requirement for well-designed, appropriately powered, and controlled studies for skin care products. This study also potentially emphasizes that skin care products can vary in effectiveness based on formulation.

Researchers conducted a survey to elicit information that would aid in the evaluation of the potential connection between flying and lymphedema. The study reported on 287 women with relapse-free breast cancer with known pathology/treatment and prospectively measured arm circumferences. Patient and treatment factors were age, type of surgery, number of nodes sampled and number positive, and radiotherapy technique.

Subjects were surveyed by phone and mail regarding flight history, precautions taken, and incidences of arm swelling subsequent to flying.

To compare the effects of compression bandaging and physical exercises versus the same management augmented by an additional 30 minutes of manual lymph drainage

Sixty women post mastectomy were randomly assigned to either a compression bandage group or a manual lymph drainage group. Fifty-one women then completed two weeks of intensive therapy and six months of maintenance therapy (26 weeks total).

• N = 51   
• MEAN AGE = CB-G group: 62 years (SD = 12.2), CDT-G group: 61.2 years (SD = 9.2)
• FEMALES: 100%
• CURRENT TREATMENT: Not applicable
• KEY DISEASE CHARACTERISTICS: Breast cancer–related lymphedema

• SITE: Single   
• SETTING TYPE: Outpatient    
• LOCATION: Krakow, Poland

• PHASE OF CARE: Late effects and survivorship
• APPLICATIONS: Palliative care 

• Randomized, noninferiority, prospective study

Summed truncated cone method was used to measures limb segment volume. Limb relative volume change (RVC) was measured using the formula treatment (SLafter treatmentNLbefore)/(NLafter SLbefore), where SL is swollen limb volume and NL is normal limb volume. Edema-related quality of life was measured using the Lymphedema Questionnaire.

In both groups, a significant reduction in SL volume, LE volume, and RVC occurred after each day of the first week of therapy. Within the two-week intensive phase, a significant decrease in SL and LE volumes occured (p < 0.001). A rebound effect occurred in the CB-G group within the first month, but after six months, the SL and LE volumes in both groups were not statistically significant. Six months after finishing intensive therapy, no significant difference in lymph volumes existed between the two groups (p = 0.3).

Patients with postmastectomy LE may have a similar benefit of CDT without MLD on limb edema reduction. Compression bandaging combined with physical exercise may be considered a basic treatment option in limb LE. 

• Small sample (< 100)
• Selective outcomes reporting
• Measurement validity/reliability questionable
• Findings not generalizable
• Subject withdrawals ≥ 10%

The results of this study may help guide overall treatment in women post mastectomy with breast cancer–related lymphedema. However, the effect of manual lymph drainage remains unexplored because immediate lymph fluid draining images and long-term lymphatic changes were not investigated.