To determine if, on the WHO analgesic ladder, passing directly from step 1 to step 3 is more effective than the traditional three-step strategy for treating chronic cancer pain; to evaluate the tolerability and therapeutic index of both strategies

Over 24 months, patients were monitored at home by telephone or a home health nurse. The study design included two arms: in one, patients moved from step 1 to step 3 (with treatment with strong opioids); in the other, patients moved from step 1, to step 2 (with treatment with weak opioids), to step 3.

• The sample was composed of 54 patients.
• Patients were age 18 and older.
• The sample was composed of patients with multiple visceral or bone metastases or locally advanced disease.

Italy

Randomized controlled trial

• Numeric Rating Scale (NRS), 0–10, to measure pain
• Five-step scale, 0–4, to measure other symptoms
• Five-step scale, 0–4, to measure degree of patient satisfaction
• Use of coanalgesics, adjuvants, and other treatments (as established by a yes/no answer)

• Going from step 1 to step 3 resulted in a statistically significant advantage over the traditional progression. Authors did not report the P value.
• Authors noted that all patients needed prophylactic treatment of constipation.

Preliminary data suggest that a direct move to the third step is feasible and could reduce some pain scores. The two-step strategy this study supports requires careful management of side effects.

The study had a small sample size.

To review the prospective randomized clinical trials (RCTs) that evaluate the use of progestins in cancer anorexia-cachexia syndrome compared with placebo in patients with hormone-independent tumors

Databases searched were MEDLINE, CANCERLIT, Embase, and CINAHL, in addition to hand searching of reference lists.

Of the 38 studies identified, 15 RCTs, published between July 1990 and June 1999, met inclusion criteria. The studies selected used various drug dosages, durations of treatment, eligibility criteria, population types, study designs, methods of assessment, methods of reporting results, and outcomes.

The review reported on 2,102 patients, compiled from six studies of 557 patients that received neither chemotherapy nor radiation, and nine studies of 1,545 patients that received some form of concomitant therapy.

Among the several outcomes analyzed, effect on body weight was assessed in all studies, and only two studies did not evaluate the effect on appetite. The most frequent method of assessing appetite was the visual analog scale.

There was a significant advantage for the use of high-dose progestins regarding improved appetite and body weight gain to support the safety and feasibility of treatment with oral progestins.

Most of the studies were short in duration, lasting from 1 to 12 weeks.

Important issues, such as dosage, duration of treatment, best time to start treatment, and eventual impact on overall improved quality of life, have yet to be defined.

To examine the effect of Nordic walking on upper-extremity strength and lymphedema

Participants were randomly assigned to the walking group or the control group, who did not participate in any rehabilitation program. The program consisted of two hour-long sessions each week for eight weeks. Sessions involved a 10-minute warm up and 40 minutes of Nordic walking at 85% of maximum heart rate, followed by 10 minutes of stretching and relaxation exercises.

• The study sample was all female with a mean age of 62.8 years.
• Patients had undergone radical mastectomy (79%) or breast-conserving surgery (21%). Mean time since surgical treatment was 7.6 years.
• Most patients had received adjuvant therapy, chemotherapy, radiation therapy, or hormonal therapy.
• No axillary dissection was reported.
• Only 34% of patients had lymphedema.

The study took place in an outpatient setting in Poland.

• Patients were undergoing long-term follow-up care.
• The study has clinical applicability for late effects and survivorship.

The study used a randomized controlled trial design.

• An isokinetic dynamometer was used to test muscle strength.
• Lymphedema volume was evaluated by measuring circumferences of both upper extremities with use of a tape measure at five levels.

A variety of changes in muscle strength were observed. No differences were found between groups in arm volume results.

The study did not provide any evidence that Nordic walking improved lymphedema.

• The sample size was small, with fewer than 100 patients.
• The authors did not indicate if exercise was done alone or in groups. 
• Only a third of patients had lymphedema.
• High variability existed in the sample of time since surgery, which would be expected to influence observance of lymphedema. 
• No other lymphedema risk factors were reported, and use of other prevention or treatment strategies were not discussed.
• The study was not blinded.

The study had several methodologic weaknesses and did not provide strong evidence either for or against the effects of Nordic walking on lymphedema after breast cancer treatment.

To establish the efficacy of using autologous stem cells (ASC) for the treatment of lymphedema associated with axillary lymph node dissection, define the possible complications, and compare outcomes with compression sleeve therapy

Twenty patients were randomly assigned to the ASC group or the control group. The ASC group received subcutaneously administered granulocyte-colony-stimulating factor (300 mg per day) for three days prior to the procedure. On procedure day, 100 ml bone marrow was harvested from east posterior iliac crest while the patient was under conscious sedation. The product was centrifuged and, under laminar flow hood, plasma was removed and transferred to sterile test tube. Cells were isolated, and CD34 cells were counted using a flow cytometer. A specimen for microbe and 0.5–1 ml of cell suspension containing 20% albumin and normal saline was administered by intramuscular injection at 30–50 sites of the affected limb, depth of 1 cm, with 25 g needle. Injection range included around the axillary and affected chest wall and part of the upper arm during the first four weeks. Use was discontinued for the following four weeks and then used again for another four weeks. Patients were not allowed to use any other modality of treatment for lymphedema, including manual lymph drainage, exercise drug therapy, or skin products. The control group was given a four-hour practice session on correct use of compression sleeve of 15–20 mmHg.

• The study sample (N = 20) was comprised of female patients with unilateral lymphedema secondary to mastectomy and axillary node dissection.
• Mean age of participants was 50–56 years.
• All patients had not had active cancer in the past five years.
• Patients were excluded from the study if they were older than 75 years, had hypercoagulable states, cardiovascular disease, or bilateral mastectomies.

The study took place at the University Hospital of the School of Medicine of the Universidad Autonoma de Nuevo Leon in Mexico.

The study has clinical applicability for late effects and survivorship.

The pilot study randomly assigned 10 women to either the ASC group or control group.

• Patient's weight was recorded.
• Limb volume measurements were taken of bilateral upper extremities in four areas, calculating mean by summation.
• Arm volume was determined by trunked cone principle were obtained weekly for 12 weeks.
• Patients were evaluated for pain, sensory loss, and arm mobility.

After 12 weeks, the ASC group had decreased pain, improved sensitivity, and improved mobility as compared to the control group. Volume reductions were similar between the two groups, with the control group being more user dependent.

The study does not provide sufficient evidence to determine potential efficacy of stem cell transplant to manage lymphedema.

• The study had a small sample size, with less than 30 participants.
• Sample characteristics present a risk of bias.
• Measurement validity and reliability is questionable.
• The findings are not generalizable.
• The intervention is expensive, impractical, or requires training.

It is important to be aware of studies being conducted. The study has limited practical value in the United States today, but as ASC becomes a more accepted and standard of care, awareness of the decreases in pain and increased sensitivity and mobility may be of benefit.

To compare the effectiveness of gentian violet (GV) and non-adherent absorbent dressing in the healing of moist desquamation

The study group were patients with moist desquamation after irradiation. Wounds were cleansed with 0.9% saline at each visit after completion of the assessment by the nurse. Then a nonadherent dressing was applied and secured with tape. Patients applied the dressing on days they were not seen by the nurse. The control group were patients taught to make homemade salted water, who rinsed the wound and then applied GV. Wound culture was taken at the entry of the study and as needed based on signs of infection.

• The study sample (N = 142) was comprised of male (87%) and female (13%) patients with head and neck cancers who were assigned to the study group (n = 73) or the control group (n = 69).
• Mean age was 54.09 years (SD = 13.9 years) in the study group and 53.07 years (SD = 11.31 years) in the control group.

The study took place at Prince of Wales Hospital at the Chinese University of Hong Kong.

The study used a randomized controlled trial open label design.

• Wound healing, healing time, and presence of infection were assessed through erythema, increased drainage, purulent drainage, increase tenderness, and fever and leukocytosis,
• Wound pain was measured on a 0–5 scale.
• Affect of mood changes, restriction of neck movement, social isolation, sleep problems, and disturbance in body image were also reported.

No significant differences were found between groups regarding wound healing, healing time, impact of mood changes, social isolation, sleep problems, disturbance in body image, or restriction of neck movement. Initial wound size was greater than 10 cm². Higher dose of radiation and overall stage were an independent determinant of prolonged time to wound healing. The dressing was not a factor. 

The study did not support the use of hydrogel dressings in the care of patients with moist desquamation.

• Patient compliance in self-care was not assessed.
• Large range in dose administration of the radiation therapy, which would be expected to influence results.

To examine effectiveness of hydrocolloid dressing in the management of moist desquamation after radiation therapy is complete

Patients with moist desquamation were randomly assigned to one of two arms: hydrocolloid dressing (experimental group) or gentian violet (GV) (control group). Chemotherapy was used in stratifying patients for subgroup analysis.

• The study sample (N = 39) was comprised of male (n = 22) and female (n = 17) patients with neck, chest, axilla, or perineal area cancer.
• Mean age was 52.06 years for the hydrogel group (SD = 11.56 years) and 51.07 years for the GV group (SD = 10.41 years).
• Of patients in the sample, 30% also received chemotherapy.

The study took place at a hospital authority of Hong Kong.

The study used a randomized controlled trial design.

• Sites were documented initially and monitored using a tracing method for moist desquamation wounds.
• Healing time was indicated in days before skin integrity returned (re-epithelialization with absence of moist desquamation and burning).
• The wound area was traced on alternating days.
• Incidence of infection assessed erythema and edema, increased drainage, change in drainage, increase tenderness, fever, or leukocytosis.
• Pain was evaluated using a frequency scale of 1–3 intensity with Wong Baker faces.

• Chemotherapy showed worse effect on wound healing that was statistically significant (f = 4.4, p < 0.01)
• Wound size in assessments was smaller in the GV arm and trend of healing seen from second visit onward.
• Pain level was higher in hydrocolloid group.
• There was no statistically significant difference in wound healing time between groups.
• Wound size decreased quicker in the GV group.
• Patients had a higher satisfaction with hydrocolloid dressing for appearance and comfort.

GV was more effective in healing of moist desquamation but hydrocolloid was more comforting and pleasing.

• The study had a small sample size, with less than 50 participants.
• The experimental group had a larger percentage with use of chemotherapy in addition to radiation, and some patients with comorbid conditions that could have affected healing
• Assessment of the GV group relied on self-report.

STUDY PURPOSE: To evaluate what is known about mechanisms of scramble therapy and investigate preliminary evidence regarding efficacy

TYPE OF STUDY: General review/semi-systematic review

• FINAL NUMBER STUDIES INCLUDED = 20
• TOTAL PATIENTS INCLUDED IN REVIEW = 1,200
• SAMPLE RANGE ACROSS STUDIES: 3–226 patients
• KEY SAMPLE CHARACTERISTICS: Four reports involved patients with chemotherapy-induced peripheral neuropathy; seven studies included patients with cancer

PHASE OF CARE: Not specified or not applicable

Most reports showed positive results for pain reduction for various pain syndromes. One double-blind, randomized trial showed no difference between controls and those receiving scrambler therapy for chemotherapy-related peripheral neuropathy.

Scramble therapy may have benefit for management of chronic pain and symptoms of peripheral neuropathy; however, current evidence is limited and weak.

• Limited number of studies included
• No quality evaluation
• Mostly low quality/high risk of bias studies
• Low sample sizes

Scrambler therapy, a neuromodulator approach to pain relief, may have some benefit in the management of chronic pain and peripheral neuropathy; however, current evidence is limited, and study designs have high risk of bias. Given the promising findings with scrambler therapy, additional well-designed research is warranted.

He-Ne wavelength 632.8 nm and output of 10 mW was administered for three minutes five days a week until completion of radiation.
Control group received  oral analgesics, anesthetics, 0.9% saline, and ovidine wash.

Physician was blinded to the type of treatment.
 

Patients with cancer of the oral cavity stages 2–4 receiving radiation 66 Gy in 33 fractions over six weeks

Computer randomization; 25 patients receiving laser treatment, 25 patients in the control group
 
Mean age of study group was 54 years (+/– 1 year); mean age of the control group was 53 years (+/–1 year).
 
Ratio of men to women was 2:1.
 

WHO mucosiis

VAS for pain

Recorded weekly
 

At the end of week 6 of RT, pain rank in the study group significantly decreased (p < 0.001) as compared to the control group (13 versus 38).

Mean pain score in the study group was 2.6 (+/– 0.64); the control group score was 6.68 (+/– 1.44) (p < 0.001).

At the end of radiation,  mucositis grade in the study group was 1.72 (+/–  0.67); the grade was 3.32 (+/–0.09) in the control group  (p < 0.001).

18 patients in the study group had grade 1, and 7 had grade 2 mucositis;
14 patients in the control group had grade 3, and 11 had grade 4.
 

Small sample size, but findings were significant at the end of radiation.

Did not report data during treatment
 

To evaluate the use of natural honey for treatment of radiation mucositis

Patients were randomly assigned to the honey treatment or control group. Patients in the intervention group were instructed to take 20 ml of honey 15 minutes before radiation therapy, 15 minutes after radiation therapy, and at bedtime. On days when they had no radiation treatment, they were to take the same amount of honey 3 times per day. Patients were evaluated at baseline, weekly during treatment, and at 3 and 6 weeks after completion of radiation therapy.

• The study reported on 55 patients with head and neck cancer.
• The mean age of patients was 47.5 years with a range of 35–65 years.
• The sample was 78% male and 22% female.

The study was conducted at a single outpatient site in India.

Patients were undergoing the active antitumor treatment phase of care.

This was a randomized controlled trial.

• The World Health Organization (WHO) mucositis scale was used.
• Body weight was recorded.

The authors reported that honey delayed the onset of severe mucositis in about 80% of the intervention group, while 63% of the control group developed severe mucositis.  Grade 3 mucositis developed in 11 patients in the control group and 5 patients in the study group. No statistical analysis was done.

This study suggests that honey may help to delay the onset of mucositis in patients with head and neck cancer during radiation therapy; however, multiple limitations in this report make it impossible to draw firm conclusions.

• The sample size was small with fewer than 100 patients.
• A risk of bias exists because of the lack of blinding and an appropriate attentional control condition.
• Although the authors reported that patients were receiving chemotherapy and radiation therapy, no information was provided regarding the chemotherapy agents used, any treatment delays, or radiation dose at which mucositis developed. 
• No statistical analysis was done.

 Findings as reported from this study are inconclusive regarding any effect of honey on the development of mucositis.

To evaluate the effectiveness of autologous fat grafting to control pain in patients with persistent postmastectomy pain syndrome (PMPS)

Patients who received lumpectomies and radiation therapy and had severe scar retraction, radiodystrophy, and chronic pain met the definition of PMPS and were considered for the study. Patients who had fat grafting underwent liposuction of the subumbilical area, and the obtained fat was processed and purified. The fat was then injected into the scar area. Study data were obtained at baseline and at one year after the procedure. Patients who had the fat graft procedure were compared to patients who did not receive the procedure.

• N = 92  
• MEAN AGE = 52.5 years (range = 33–68 years)
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Patients with breast cancer and PMPS; none had chemotherapy, local recurrence, or previous breast surgery other than the initial lumpectomy

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

• PHASE OF CARE: Active antitumor treatment

Prospective trial

• Visual Analog Scale (VAS) for pain

Among those who had the fat graft procedure, there was a mean reduction of 3.1 points for pain compared to a mean reduction of 0.9 points in the comparison group (p ≤ 0.005).

Autologous fat grafting may have reduced PMPS.

• Small sample (< 100)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Measurement/methods not well described
• Other limitations/explanation: It was not clear if the VAS measurement was of worst pain, average pain, etc., or over what time period it was considered.

Persistent pain as a consequence of surgical treatment for breast cancer is a clinical problem for which the general treatment is pain medication. Nurses need to be aware of this syndrome and educate patients about alternative approaches that may be available for management. Additional well-designed research regarding the efficacy of fat grafting for this population is needed.