The intervention was a self-administered stress management training (SSMT) program for patients treated with radiation therapy. The usual care only (UCO) intervention included the usual psychosocial care typically provided at the institution where patients were receiving treatment. Participants in the SSMT program met individually with a nurse for approximately five minutes to receive instructional materials and explanations. The instructional materials consisted of a 15-minute prerecorded videotape, a 12-page booklet, and a 35-minute prerecorded audiotape titled “Active Relaxation,” which taught paced breathing, active relaxation, and positive thinking with guided imagery instructions. Data were collected at baseline and weeks 1, 2, and 3.

• The study reported on a sample of 310 patients prior to starting treatment with radiation.
• The UCO group had 156 patients, and the SSMT group had 154 patients.

Multiple centers in South Florida

A randomized controlled trial design was used.

• Mental Component Summary score of the Medical Outcomes Study–short form (SF-36)
• Center for Epidemiologic Studies–Depression Scale (CES-D)
• State-Trait Anxiety Inventory (STAI)–state anxiety
• Statistical analyses repeated measures using SAS PROC MIXED based on unstructured covariance matrix model assumption
• The models used for analysis included the baseline measures as covariates: the effects of treatment alone, time alone, the interaction of treatment with time, the quadratic effect of time, and the quadratic effect of treatment and time.

SSMT is effective only in those patients receiving radiotherapy with initially higher levels of psychological distress at baseline.

Special training needs include the creation of the SSMT tool (instructional materials, video tables, and audiotapes).

Intervention requires screening for psychological distress.

To update the 1999 American Society of Clinical Oncology (ASCO) guideline for antiemetics in oncology 

The update committee reviewed studies identified through a literature search.

Databases searched were MEDLINE, the National Library of Medicine, and the Cochrane Collaboration Library (1998-Feb. 2006).

Studies were included if they were phase II and III randomized, controlled trials.

The search identified the following studies.

• Systematic reviews and meta-analysis on neurokinin 1 (NK1) receptor antagonists in the prevention of chemotherapy-induced nausea and vomiting (CINV) related to high-dose chemotherapy
• A meta-analysis of randomized trials assessing the efficacy of dexamethasone in controlling CINV
• Three systematic reviews and meta-analyses of 5-hydroxytryptamine 3 (5-HT₃) receptor antagonists

Additional materials provided to the committee were

• Two additional systematic reviews available prepublication from the Cancer Care Ontario Program in Evidence-Based Care
• Consensus statements and guidelines from Multinational Association of Supportive Care in Cancer (MASCC).

• The combination of 5-HT₃ receptor antagonist, dexamethasone, and aprepitant is recommended before highly emetogenic chemotherapy (HEC). This combination is recommended for patients receiving an anthracycline and cychlophosphamide. At equivalent doses for the prevention of acute emesis, 5-HT₃ receptor antagonists have equivalent safety and efficacy. 
• For patients receiving HEC, antiemetic agents of lower therapeutic index are not an appropriate first choice. Agents with lower therapeutic index should be used in patients who are unable to take to a 5-HT₃ receptor antagonist, dexamethasone, and aprepitant because of allergy or side effects or for whom these agents have been ineffective.
• For patients receiving moderately emetogenic chemotherapy (MEC), a combination of a 5-HT₃ receptor antagonist and dexamethasone is recommended.
• In patients receiving cisplatin and all other agents of high emetic risk, the combination of aprepitant and dexamethasone is recommended for the prevention of delayed emesis.
• The combination of a 5-HT₃ receptor antagonist and dexamethasone is no longer a recommendation for the prevention of delayed emesis after HEC.
• The recommendation to lower the dose of dexamethasone when administered as an antiemetic with aprepitant does not apply to corticosteroids for anticancer therapy.

To compare, in clinical practice, the effect and safety of a new matrix fentanyl patch (Fentanyl Improved Transdermal [FIT]) patch) to oral and other transdermal opioid treatment

Patients were randomly assigned to either FIT patch or standard opioid treatment via oral or transdermal route. Morphine was the only rescue medication allowed. Patients could receive radiotherapy and chemotherapy as well as nonpharmacologic and pharmacologic pain management therapies. Patients randomized to FIT therapy switched from existing regimens to FIT therapy by means of standard conversion ratios. Patients had an initial screening visit and four additional visits. Each evening each patient assessed his or her pain and recorded the pain rating in a diary. Adverse events were monitored in follow-up visits through the 30-day trial period and for one week longer. Patients assessed adverse events on a four-point scale and recorded the rating.

• The sample of patients who completed the trial was composed of 170 patients.
• In the FIT group, mean patient age was 63.1 years (SD = 11.04 years). In the control arm, mean patient age was 61.3 years (SD = 11.66 years).
• Of all patients, 40% were female and 60% were male.
• Overall, 11% of patients randomized were opioid naive.
• Authors did not report cancer diagnoses. All patients had a baseline Karnofsky performance score of 50 or higher.

• Multisite
• Outpatient
• Seven European countries

Randomized open-label parallel-group design

• Numeric rating scale (0–10), to measure pain intensity
• Four-point scale to rate adverse events, including constipation, nausea, sleep disturbance, and daytime drowsiness

• There was no significant difference between groups regarding pain intensity ratings.
• Subgroup analysis revealed no differences based on concomitant chemotherapy or radiotherapy or on subgroup analysis based on nocioceptive versus neuropathic pain.
• Between groups, there were no significant differences in the prevalence or severity of adverse effects.
• Authors observed no new or unexpected adverse drug reactions.

Results showed no differences, in terms of pain management or adverse effects, between the new transdermal patch and standard transdermal or oral opioid treatment. Findings suggest that the new type of patch is safe and, in terms of efficacy, similar to standard treatments.

• The study has a risk of bias due to no appropriate control group.
• Authors provided no analysis of other medications or approaches used for pain management. (These were not controlled in the study.) Authors did not report analysis of morphine use for breakthrough pain.
• Patients' diaries were the source of adverse events and pain intensity scores. Note, however, that authors stated that patients' records regarding rescue medication, for example, could not have been accurate. If patients' records were inaccurate, the study should have provided objective or observer scoring.

Transdermal fentanyl, delivered by means of conventional patch or FIT patch, is an effective means of controlling cancer pain.

To assess the efficacy and long-term tolerability of infranasal fentanyl spray (INFS)

In an initial titration phase, the effective dose of INFS was determined for each patient. An effective dose was defined as one that was successful in treating three of four episodes of breakthrough pain. If pain relief was insufficient, an additional dose was administered in the alternate nostril. Titration was repeated if the patients’ background opioid dosage was adjusted during the trial. During the efficacy phase patients received, in randomized double-blind sequence, the titrated effective dose of INFS or placebo for administration at home. Patients were randomized to treatment sequences for eight episodes of breakthrough pain. Patients used a diary to record pain intensity at 0, 10, 20, 40, and 60 minutes after administration. Pain ratings were according to a numeric rating scale. Patients were monitored during the 10-month open-label extension phase. Patients received 30-day supplies of INFS, in appropriate doses, during monthly clinic visits. Weekly telephone contact provided data about adverse events, concurrent medications, and INFS efficacy.

• In all,120 patients were enrolled and achieved an effective dose; 113 were randomized and 111 were included in the intent-to-treat analysis.
• Mean patient age was 60.6 years. Age range was 35–79 years.
• Of all patients, 49.5% were female and 50.5% were male.
• The study included patients with multiple cancer sites. Most frequent diagnoses were breast, lung, colon-rectal, and female genital cancer. All patients in whom race was reported were white. Of all patients, 54% received fentanyl for background pain and 43% received morphine sulfate. The other subjects received other opioids.

• Multisite
• Outpatient
• Anesthesiology departments, palliative care units, and oncology clinics in Austria, Denmark, France, Germany, and Poland

Double-blind randomized, double-dummy two-way crossover study

• 11-point numeric rating scale (0–10) of pain intensity
• Five-point scale (0 = poor, 5 = excellent) that provided patient's general impression of treatment efficacy
   

• INFS was associated with pain intensity decreases that were significantly greater than those associated with placebo (p < 0.001).
• Compared with placebo, INFS pain reduction improved with increases in dose related to time after administration (p < 0.0001). Rating of general impression of efficacy at 60 minutes after use was significantly higher (p < 0.001) with INFS than with placebo.
• During the efficacy phase, 22 patients experienced adverse events. Most common effects were nausea and vertigo.

INFS titrated to an effective dose demonstrated some effectiveness in relieving breakthrough pain in this group of patients. Long-term tolerability could not be clearly determined because of the small number of patients who completed the extension phase of the study. Most patients appeared to tolerate IFNS well.

• Approximately one-third of patients who entered the extension phase of the trial withdrew consent. Reasons for withdrawal were not cited, and findings did not include withdrawals as adverse events. Lacking details about withdrawals, the actual prevalence and types of adverse events associated with long-term INFS use are unknown.
• Authors considered a small numeric reduction in pain scores—from baseline to 10 minutes, a difference of 0.5 or a change greater than 2—to mean that the treatment was clinically effective. Whether a patient would consider such levels of change indicative of effective treatment is unknown.

Findings suggest that INFS may be a useful adjunctive approach to deal with the breakthrough pain of patients with cancer who have chronic opioid-managed pain. INFS may be more useful as a short-term, rather than a long-term approach; the matter of long-term efficacy and tolerability requires further study.

To determine whether tapentadol prolonged-release (PR) is effective and tolerable for managing moderate to severe tumor-related pain

Patients whose pain was rated 5 or above on an 11-point scale were randomized (2:1) and titrated to an optimal dose of tapentadol PR (100–250 mg BID) or morphine sulfate CR (40–100 mg BID) over two weeks. Immediate-release morphine sulfate was allowed as needed as a breakthrough medication. During the last three days of titration, patients who achieved an average pain intensity of less than 5 and took less than 20 mg per day of rescue pain medication entered a four-week maintenance period. Patients who received tapentadol were rerandomized (1:1) to either tapentadol BID or a placebo for the maintenance period. Response at the end of titration and response at the end of the maintenance were assessed. Tolerability and side effects were evaluated.

• N = 327
• AGE = 68% < 65 years, 32% ≥ 65 years
• MALES: 53%, FEMALES: 47%
• KEY DISEASE CHARACTERISTICS: The most common neoplasms included were breast and nipple cancers and non-small cell neoplasms of the respiratory tract. Metastases were present in greater than 75% of all patients.   

• SITE: Multi-site    
• SETTING TYPE: Not specified    
• LOCATION: 71 sites in 16 countries

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

Randomized-withdrawal, parallel-group, active- and placebo-controlled, double-blinded study

During the study, pain levels were evaluated with an 11-point Numeric Rating Scale (NRS) twice daily. The proportion of patients classified as responders (patients who completed 28 or more days, had a mean pain intensity score < 5, and had a mean total daily dose of ≤ 20 mg rescue medication during the maintenance period) was evaluated as a primary endpoint during the titration and maintenance periods. Mean pain intensity at the start of the maintenance period was calculated as the mean daily pain intensity scores during the last three days of the titration period. Mean weekly pain intensity during the maintenance period was calculated from the mean daily pain intensity scores during each week of the maintenance period. Adverse events were coded using the Medical Dictionary for Regulatory Activities v15.0. The treatments for emergent adverse events in all groups were collected and compared as were specific gastrointestinal and nervous system effects and general disorders or administration site effects.

Patients receiving tapentadol were twice as likely to respond than the patients who received a placebo. Tapentadol PR was noninferior to morphine CR (p < 0.001). Mean pain intensity scores improved in both the tapentadol PR and morphine CR groups during titration. These reductions were sustained throughout the maintenance period. There were no statistically significant differences between the tapentadol and placebo groups in changes in pain intensity from the start of maintenance to weeks 1–4 (p ≥ 0.0152). A higher percentage of patients in the placebo group (72.1%) took ≥ 20 mg per day of rescue morphine immediate-release compared to the tapentadol (71.4%) or morphine CR (61.5%) groups. During titration, 50% of patients in the tapentadol group and 63.9% of patients in the morphine group reported one or more treatment-emergent adverse effects (TEAEs). A smaller percentage of patients receiving tapentadol PR had any TEAEs (p = 0.0039) than those receiving morphine CR.

Tapentadol PR 100–250 mg BID was effective in the treating tumor-related pain. The analgesic effect of tapentadol PR was not inferior to morphine CR and had better overall and gastrointestinal tolerability than morphine CR. However, more tapentadol users required rescue pain medication than those taking morphine CR.

• Findings not generalizable
• Subject withdrawals ≥ 10%  
• Other limitations/explanation: The comparison of tapentadol PR and morphine CR was limited to two weeks because of the study design.

Tapentadol, one of a new class of centrally acting analgesics, was effective in treating tumor pain and was generally better tolerated than morphine CR. Nurses should be familiar with the common side effects associated with this medication including nausea, vomiting, constipation, dizziness, sleepiness, and fatigue to safely care for patients receiving this drug.

To evaluate the effects of a stepped psychotherapeutic intervention on patients with baseline anxiety

Patients who had completed curative therapy, were referred for follow-up, found to have relevant levels of distress, and consented to participation had a telephone interview at baseline. After the interview, they were randomized to usual care or the stepped program, which included watchful waiting, guided self-help via the Internet or a booklet, face-to-face problem-solving therapy, and psychological interventions and/or medications. Time frames for data collection varied depending upon the duration of the stepped program. General measures were obtained at 3, 6, 9, and 12 months after study entry. Usual care consisted of no psychosocial care in 64% of the group.

• N = 156, 106 at 12-month follow-up   
• MEAN AGE = 62 years (SD = 9.4 years)
• MALES: 60.9%, FEMALES: 39.1%
• CURRENT TREATMENT: Not applicable
• KEY DISEASE CHARACTERISTICS: Patients with head and neck or lung cancer in various stages
• OTHER KEY SAMPLE CHARACTERISTICS: Of the patients, 77.6% had anxiety or a depressive disorder.

• SITE: Single site   
• SETTING TYPE: Multiple settings    
• LOCATION: Netherlands

PHASE OF CARE: Transition phase after active treatment

Single-blind, randomized, controlled trial

• Hospital Anxiety and Depression Scale (HADS)
• European Organization for Research and Treatment of Cancer Core Quality of Life (EORTC QLC-C30)
• EORTC IN-PATSAT32 for inpatient satisfaction with care 
• Composite International Diagnostic Interview (CIDI) for the presence of depression or an anxiety disorder

The course of anxiety (p = 0.046) and depression (p = 0.007) was better for the intervention group than for the controls. When corrected for baseline anxiety and depression, depression was better for the intervention group over time (p < 0.001), but anxiety was not significantly different (p = 0.061). The stepped program had more influence over the course of symptoms among patients with a depression or anxiety disorder compared to those without a psychiatric disorder (p = 0.001). Among those without a psychiatric disorder, no differences in anxiety or depression scores were observed after a six-month measurement.

The stepped psychological intervention approach was shown to be effective to reduce anxiety and depression in the short-term, and had particular effectiveness for individuals with psychiatric disorders.

• Baseline sample/group differences of import
• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)
• Unintended interventions or applicable interventions not described that would influence results
• Subject withdrawals ≥ 10% 
• About 40% were lost to follow-up at six months.
• Patients were not blinded.  
• No information was provided regarding medication use, etc.
• More patients in the intervention group used alcohol.
• Although all patients had clinically relevant anxiety at study entry, the majority of patients in the usual care group had no interventions.
• Patients had completed initial treatment at highly varied time points prior to the study.

Psychiatric and stepped psychological interventions resulted in relatively short-term improvement in anxiety and depression among patients with cancer and anxiety. Interventions were most helpful for individuals with anxiety or depressive disorders over a longer period of time as well.

To determine the effectiveness of a lay-administered tailored education and coaching intervention on cancer pain severity, pain-related impairment, and quality of life  

Patients with baseline “worst pain” of more than 4 on a 0–10 scale or at least moderate functional impairment were randomized to tailored education coaching (TEC) or enhanced usual care (EUC). TEC was delivered by a health educator in a private room one hour prior to the patients' visit with their healthcare provider. The intervention was a brief, patient-centered, tailored education and coaching intervention designed to enhance skills and self-efficacy for communicating with the oncologist while also correcting common misconceptions. The EUC intervention included review of selected aspects of a National Cancer Institute (NCI) booklet on pain control by a health educator. The TEC patients also received the NCI booklet. Patients completed questionnaires before and after the visit and were interviewed by telephone at 2, 5, and 12 weeks. Oncologists and follow-up assessors were blinded to patient group assignments.

• The study reported on 258 patients (126 in the intervention group and 132 in the usual care group).
• Mean patient age was 58 years.
• The intervention group was 77.8% female and 22.2% male. The usual care group was 79.5% female and 20.5% male. 
• Patients had breast and lung cancers and were predominantly white (71%).

• Mutlisite
• Outpatient setting
• Three healthcare systems and one private practice located in the metropolitan Sacramento, CA, area
• Forty-five medical oncologists and three radiation oncologists participated in the study.

Patients were undergoing multiple phases of care.

The study was a randomized controlled trial.

• Pain severity: two component numeric scales     
• Pain impairment: five of thesix items from the Medical Outcomes Study
• Functional status and well-being: physical and mental health components of the SF-12
• Pain misconceptions: 11 five-point Likert scale items based on the Short Barriers Questionnaire
• Self-efficacy for communicating about pain with the cancer doctor: five items in the Perceived Efficacy in Patient-Physician Interactions Scale
• Pain-control self-efficacy: 2 items from the pain management subscale of the Chronic Pain Self-Efficacy Scale
   

The TEC patients had an improvement in pain-related impairment at two weeks (–0.025 points on a five-point scale, 95% confidence interval –0.43 to –0.06, p = 0.01), but it was not sustained at 6 and 12 weeks (p > 0.20). Pain severity was not improved at two weeks (–0.21 points on an 11-point scale, –0.60 to 0.17, p = 0.27). Pain misconceptions in both the intervention and control group decreased significantly between baseline and the two-week follow-up interview (p < 0.001), but there was no significant effect of the intervention on misconceptions at the two-week follow-up (p = 0.8). Communication self-efficacy increased more among the TEC patients than in the control group (p < 0.001).

TEC provides a temporary improvement in pain impairment but not in pain severity.

The TEC intervention was designed to be brief and easy to deliver, but the health educator needed 30–40 hours of training and regular reinforcement (several hours every three to six months) in order to deliver the intervention appropriately. Physicians were not randomized to the study, so they may have learned from the TEC patients and applied it to the EUC patients. Generalizability of findings is limited due to the fact that the study was conducted in a metropolitan area in California, with no blinding.

Because the TEC provided only temporary relief of pain impairment and no improvement of pain severity, it is not recommended for use in cancer-related pain management.

To estimate the effect of patient-centered tailored education and coaching (TEC) on the likelihood of analgesic treatment adjustment during oncology visits; to estimate the influence of treatment adjustment on subsequent cancer pain control

Patients with at least a moderate baseline pain received TEC or control just prior to a scheduled oncology visit. Just after the visit, they reported on whether the physician recommended a new pain medication or a change in the dose of an existing medication. Pain severity and pain-related impairment were measured 2, 6, and 12 weeks later. TEC included assessing knowledge, attitude, and preferences; correcting misconceptions; teaching about pain control and communication with providers; planning communication; and rehearsing communication with physicians. Sessions occurred one hour before initial clinic visits and were conducted on an individual basis. Sessions were recorded on audiotape. Control patients received the Natiional Cancer Institute booklet on pain control. Patients completed questionnaires immediately after a clinic visit.

• The sample was composed of 258 patients.
• Patients' age range was 18–80 years.
• Of all participants, 21.4% were male and 78.6% were female.
• Diagnoses in the sample included lung, breast, prostate, head and neck, esophageal, colorectal, bladder, and gynecologic cancer.
• Patients reported a score of 4 or higher, on a 0–10 scale, when asked to cite worst pain during the past two weeks or pain during the same period that interfered at least moderately with functioning.
• Potentially eligible patients were identified using computer-generated lists. Consenting patients received an enrollment packet by mail and were promised $80 compensation for completing the trial.

Settings included three health systems—academic medical center, health maintenance organization, and Veterans Affairs hospital—and one private practice, all in Sacramento, California.

• Phase of care: active treatment
• Clinical applications: elder care, palliative care

Randomized controlled trial

• Medical Outcomes Study Pain Impairment Scale
• Postvisit questionnaire regarding pain medication changes

• Patients assigned to TEC were more likely than controls to report a change in the analgesic treatment regimen (60% vs. 36%, p < 0.01).
• Significant effects persisted after adjustment for baseline pain, study site, and physician (adjusted odds ratio 2.61, 95% CI 1.55, 4.40, p < 0.01).
• In a mixed-effects repeated-measures regression, analgesic change was associated with a sustained decrease in pain severity (p < 0.05).

TEC increases the likelihood of self-reported, physician-directed adjustments in analgesic prescribing. Treatment intensification is associated with improved cancer pain outcomes.

• The study had low accrual rates.
• Invesigators obtained data about independent and dependent variables by means of patients' self-reports. The study shows poor concordance between patients' reports and medical record review.
• Authors did not assess appropriateness of physicians' decisions.
• Regression effects that may cause between-group comparisons may appear to be larger than they would be if analgesic change were randomly assigned.
• Time points at which pain severity were measured are unclear.

A routine oncology visit is an opportunity to adjust a patient’s analgesic regimen. Available evidence suggests that clinicians often miss opportunities to intensify analgesic regimens appropriately. Oncologists are often unaware of patients’ pain. Patients may be reluctant to discuss pain because of misconceptions about pain management or fear of distracting the physician. The findings of this study suggest that interventions to counter this reluctance, and to improve pain management, include education, including role-playing, that helps patients plan communication with physicians.

The study design was based on a goal of 120 patients, so that the two-sided, 0.05-level Wilcoxon rank sum would have a power of 97.5% to detect an improvement in diarrhea severity. After stratification, patients were randomly assigned to the experimental group (4 grams of glutamine twice per day for 7 days per week during radiation and for 2 weeks thereafter) or an identically appearing placebo (glycine) for the same time period.

• The study reported on 129 patients from 14 institutions.
• Patients were stratified by
  • History of anterior resection of the rectum versus no prior rectal surgery
  • Total planned cumulative radiation dose
  • Use of fluorouracil (FU)
  • Primary tumor site (rectal versus prostate versus gynecological versus other).

This was a two-arm, placebo-controlled, randomized clinical trial.

The primary measure of treatment efficacy was diarrhea levels, which were evaluated using a bowel function questionnaire that was derived from previous studies on radiation therapy and bowel functioning. Participants completed the questionnaire weekly for 4 weeks, then at 12- and 24-month follow-up intervals. Toxicity was measured using National Cancer Institute (NCI) Common Terminology Toxicity Criteria for Adverse Events: Diarrhea.

No significant differences were found in incidence of diarrhea (p = 0.99), stools per day, maximum stools per day, antidiarrheal agent used, or use of loperamide.

• This study was inconsistent with other studies which found a significant effect (improvement) in diarrhea with glutamine supplementation. Further research is needed to determine whether a lower dose of glutamine was used in this study.
• The authors did not report on the validity or reliability of the bowel function questionnaire.
• No dose-response data was provided to assess whether higher doses or longer pretreatment use of glutamine would have been more effective in treating or preventing diarrhea.

To compare the long-term efficacy of pneumatic compression and low-level laser therapies in the management of postmastectomy lymphoedema

Sixty-four women who had undergone modified radical mastectomy with complete axillary dissection and radiotherapy were recruited for the study. All patients gave informed consent, and the hospital ethics committee had approved the study protocol. Patients who had a history of arm lymphedema of at least three months were recruited to the study. Fourteen patients were excluded from the study (three had current metastases, five had continuing radiotherapy, one had cellulitis, two had a history of receiving a physical therapy program in the previous six months, one was using diuretic agent for hypertension, and two refused the treatment and did not provide informed consent). Patients were randomized to the pneumatic compression therapy group (group I, n = 25) or the low-level laser therapy group (group II, n = 25) by consecutive alternate allocation according to the admittance to the study clinic. The physician who randomized the patients was blind to the treatment groups. Group I received two hours of therapy with an intermittent pneumatic compression therapy device. A pressure of 60 mmHg, which is generally recommended for the treatment of lymphedema, was used. Total treatment period was four weeks and consisted of 20 sessions. Group II received 20 minutes therapy (2800 Hz, 1.5 J/cm2) with a Ga-As 904 nm laser device three times a week. Total treatment period was four weeks and consisted of 12 sessions. Laser therapy was administered at three points on the antecubital fossa and at seven points on the axilla where the lymph nodes accumulated. All patients were advised to perform daily limb exercises (active range of motion, elevation and pumping exercises), hygiene, and skin care. In addition to pre- and post-treatment evaluation, follow-up measurements were performed at 3, 6 and 12 months by the same physician.

• The study sample (N = 50) was comprised of two groups receiving either pneumatic compression therapy (group I, n = 25) or low-level laser therapy (group II, n = 25). 
• Mean age for group I was 51.2 years and group II was 45.4 years. 
• All patients had breast cancer-related lymphedema. 
• Patients were included in the study if they had a history of arm lymphedema of at least three months. 
• Patients were excluded from the study if they
  • Had current metastases, continuing radiotherapy, cellulitis, venous thrombosis, chronic inflammatory diseases, a history of severe trauma, or photosensitivity
  • Were using any medications that affect body fluid and electrolyte balance
  • Had limitation of the upper-extremity joints
  • Had a history of physical therapy other than skin care and home exercises directed to lymphedema within the previous six months.

The study took place at the Department of Physical Medicine and Rehabilitation of Cukurova University in Turkey.

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.

• The affected and unaffected upper limbs of the patients were measured by tape at seven anatomic sites, including the axilla, 10 cm proximal and distal to the antecubital fossa, elbow, 5 cm proximal to the wrist, wrist, and mid-palm. Lymphedema was defined as a difference of more than 2 cm at least three of the seven points. The sum of the circumferences of the affected and unaffected limbs was calculated and the difference between these two values was recorded as delta circumference.
• Pain with motion was measured by a visual analog scale of 0–100 mm, ranging from no pain to very severe pain.
• Range of motion of the upper-extremity joints was measured using a conventional goniometer when patients were lying in the supine position.
• Grip strength was measured by portable hydraulic hand dynamometer. The measurements were performed when patients were seated in straight position, with the shoulder adducted, elbow flexed at 90°, and forearm in neutral rotation. A mean of three attempts was calculated, with a 15-second rest in between each of three contractions.

Delta circumference decreased significantly at one, three, and six months within both groups, and the decrease was still significant at month 12 only in group II (p = 0.004). Improvement of group II was greater than that of group I post-treatment (p = 0.04) and at month 12 after 12 months (p = 0.02). Pain was significantly reduced in group I only at post-treatment evaluation, whereas in group II it was significant post-treatment and at follow-up visits. No significant difference was detected in pain scores between the two groups. Grip strength was improved in both groups, but the differences between groups were not significant.

Patients in both groups improved after the interventions. Group II had better long-term results than group I. Low-level laser might be a useful modality in the treatment of post-mastectomy lymphedema.

• The study sample was small, with less than 30 participants for each group and less than 100 participants in total. 
• The study lacked a sham or control group because of ethical issues.
• Patients were not blinded because of the different types of treatment. 

Prospective randomized controlled studies with a larger sample size are needed to better understand the efficacy of low-level laser therapy and pneumatic compression in the treatment of postmastectomy lymphedema. In addition to these suggested treatment modalities, patients are recommended to perform daily limb exercises and follow skin care instructions throughout their lives.