To determine if the use of a hologram bracelet is effective in the management of chemotherapy-induced nausea and vomiting (CINV) in adult patients with cancer

A hologram bracelet was used as the intervention, and a counterfeit bracelet was used as the placebo. The control group did not use any bracelet. All groups received standard antiemetics. Data were collected through three cycles of chemotherapy for each participant using daily diaries and the Functional Living Index-Emesis (FLIE) questionnaire. The hologram bracelet is said to stabilize body energy by covering very low intensity magnetic fields. Theoretically, it attracts special charges that affect the brain in terms of regulating neurotransmitters that play a role in causing nausea and vomiting. Another theory is that the hologram reflects infrared rays into the body, which stimulate secretion of these same neurotransmitters. Data were collected at baseline, on the first day of chemotherapy, and then daily on days 2–5 for three cycles. Patients were randomized to one of three groups: hologram, placebo, and usual care control.

• N = 175   
• AGE = 18–75 years
• MEAN AGE = 42.3 years
• MALES: 31.4%, FEMALES: 68.6%
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: Any type and stage of cancer
• OTHER KEY SAMPLE CHARACTERISTICS: Inpatient and outpatient adults who received at least one cycle of chemotherapy and experienced nausea and vomiting, various levels of emetogenicity of treatment with 58.5% on HEC regimens

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

PHASE OF CARE: Active antitumor treatment

• Randomized, double-blinded, placebo-controlled trial

• Participants’ medical records
• FLIE questionnaire
• Daily diary

Less anticipatory chemotherapy-induced vomiting (CIV) severity existed in the hologram group in cycles 2 and 3 (p < 0.5). The hologram group experienced less anticipatory chemotherapy-induced nausea (CIN) only during the cycle 3 (p < 0.03). In the acute phase, no difference in CIV existed between the three groups but less CIN in the intervention group at all three cycles (all p's < 0.05). In the delayed CIV phase, the severity and frequency of CINV was significantly lower in the hologram group. Men experienced a greater positive effect than women. Overall, the hologram group had positive effects on both nausea and vomiting but greater effects on nausea. A decrease in antiemetic use was also noted. In evaluating the FLIE, higher mean scores were found in the hologram group during all three cycles of chemotherapy (p < 0.05).

The use of the hologram bracelet worn at all times during three cycles of emetogenic chemotherapy showed a significant decrease in CINV, higher levels of activities of daily living, and decreased use of antiemetics. Antiemetic prophylaxis regimens are not clearly described.

• Unintended interventions or applicable interventions not described that would influence results
• Changes in chemotherapy and antiemetic regimens during the three cycles
• Influence of the placebo effect and self-reporting biases
• Varied emetogenic levels of chemotherapy with no relevant subgroup analysis
• Antiemetic medications used are not clearly reported or standardized
• The use of rescue medication is not addressed.

The use of a hologram bracelet may be effective as a complement to standard antiemetic use in reducing CINV but especially in increasing quality of life during treatment. This may have an effect particularly on nausea symptoms.

To investigate the effectiveness of psychotherapy for treating depression in incurable cancer patients and to evaluate the effectiveness of psychotherapy on anxiety, general psychological distress, control of cancer symptoms, quality of life, and coping measures

Databases used, in September 2005, were Cochrane Pain, Palliative and Supportive Care Group Register, Cochrane Controlled Trials Register, MEDLINE, EMBASE, CINAHL, and PsycINFO. Investigators looked for additional studies in the  SciSearch database and contacted the authors of significant studies to identify trials for inclusion. Search keywords were psychotherapy, aromatherapy, art therapy, autogenic training, behavior adjustment therapy, biofeedback, implosive therapy, relaxation, yoga, hypnotherapy, imagery and psychotherapy, counseling, group therapy, socio-environmental therapy, depression, depressed, depressive, neoplasm, tumor, cancer, and carcinoma or malignancy. Authors provide extensive detailed lists of the search strategies and terms used with each database.

To be included in the analysis, studies had to 

• Involve psychotherapy of any kind, including interventions such as music therapy
• Include at least one validated measure of the severity of depression, either by self-report or rating by an observer
• Include only participants 18 years old or older who had a primary diagnosis of incurable cancer
• Be randomized controlled trials

Excluded from the analysis were interventions that were not considered forms of psychotherapy, such as aromatherapy and therapeutic touch.

The initial search identified 176 studies for possible inclusion. Of these, two independent raters identified 16 studies as potentially suitable. Six of these were eliminated because they involved interventions such as aromatherapy or structured nursing assessment. The final set of literature included 10 studies. None met risk-of-bias criteria for “good” study quality.

• The final sample of 10 studies included a total of 780 participants. Sample size per study was 20–235.
• Subjects for meta-analysis were obtained from three main groups: patients with metastatic breast cancer (five studies), patients receiving palliative care (three studies), and various patients with advanced cancer (two studies).

Of the 10 studies analyzed

• Five studies used, for the most part, supportive psychotherapy
• Three studies investigated, mosly, behavioral therapies, including relaxation techniques
• Some used cognitive behavioral and problem-solving therapies
• One study involved group therapy sessions

The duration of interventions, across studies, was 3–5 sessions.

Six studies had data that could be used in the meta-analysis of the effects of psychotherapy on depression. All used the Profile of Mood States (POMS) scale. Four involved supportive psychotherapy, one involved cognitive behavioral therapy, and one used problem-solving therapy.

• Combined data involved 292 participants in the psychotherapy arm and 225 in the control arm.
• Combined data showed that psychotherapy had a significant effect on depression among participants (SMD = –0.44, 95% CI –0.08 through –0.80).
• Statistically significant heterogeneity was observed among the six studies (p = 0.004).

Five studies could be used in the meta-analysis of the effect of psychotherapy on anxiety and general psychological distress. The five studies included 242 participants in the psychology arm and 169 in the control.

• Psychotherapy had a borderline effect on anxiety (SMD = –0.68, 95% CI 0.01 through –1.37).
• Statistically significant heterogeneity was observed (p < 0.00001).
• Four studies provided data on general psychological distress by using the POMS total mood disturbance score. Analysis included 237 participants in the psychotherapy arm and 166 in the control.
• Psychotherapy had a significant effect on distress (SMD = –.94, 95% CI = –0.01 through –1.87).
• Heterogeneity was statistically significant (p < 0.00001).

Other findings follow.

• Too few studies provided data to evaluate symptom control, quality of life, coping measures, or severity of physical symptoms.
• Subgroup analysis was done using studies of patients with metastatic breast cancer. Findings were similar and significant for depression, anxiety, and general distress.

Findings suggest that the depression that patients with advanced cancer experience can be effectively ameliorated by psychotherapeutic intervention. However, questions remain concerning duration of effectiveness and timing of interventions. Most studies included in the meta-analysis investigated the impact just after or during continuous cancer treatment and included a limited number of sessions. Effectiveness is further in question because studies did not show that patients were clinically depressed or suffered from depressive disorders. Authors noted that the effects of psychotherapy, as revealed in the meta-analysis, were almost comparable to those observed with antidepressant pharmacotherapy.

Although the analysis discovered significant findings regarding the use of psychotherapeutic interventions for depression, anxiety, and psychological distress, the quality of individual studies was not high and studies involved significant heterogeneity. Subjects’ physical status was not clearly defined. Some studies involved patients during active treatment, so it is unclear if findings are applicable to patients with end-stage disease. The cost associated with psychotherapeutic interventions requiring trained mental health professionals could not be evaluated. Providing such  interventions for many patients may be impossible, from the financial standpoint. Not enough studies met the criteria for meta-analysis to allow the authors to determine the impact of demographic and cultural differences on findings. These differences may influence involvement in and response to psychotherapy. Similarly, differences between types of therapy employed could not be evaluated.

Future research in this area should clarify the cost-effectiveness of psychotherapy. This area could benefit from research studies of higher quality, which would clarify effectiveness. Investigators noted that experts often recommend specific types of therapy, particularly cognitive behavioral therapy. However, this systematic review points to the need for more well-designed clinical trials to clarify the actual effect of each therapy on depression as well as on other patient outcomes.

Patients kept ice chips and ice-cold water in their mouths for 15 minutes before and during as well as for an additional 90 minutes after melphalan infusion. Patients were advised to continue swirling ice chips around in their mouths and to gargle and swallow ice-cold water every 10–20 minutes throughout oral cryotherapy. Patients were consecutively compared with a historical control group (no cryotherapy). Fludarabine was administered at 25 mg/m² daily for five days; melphalan was administered at 70 mg/m² daily for 15 minutes for two days.

The sample consisted of 18 patients undergoing allogeneic hematopoietic stem cell transplant (HSCT) receiving fludarabine and high-dose melphalan (140 mg/m²).

Common toxicity criteria (CTC) grading of stomatitis (0–4) was done every day from the first day of HSCT to day 28. The maximum grade recorded for each participant was considered that patient's grade.

• The cryotherapy group reported less moderate to severe mucositis with 2 out of 18 patients (11.1%) in the cryotherapy experiencing moderate to severe mucositis (grade 2 or 3) and 6 out of 7 patients (85.7%) in the historical control group experiencing grade 2 or 3 mucositis (p = 0.001).
• No patients in the cryotherapy or control group developed grade 4 mucositis.
• Side effects included chills (n = 7; 39%) and nausea (n = 4; 22%), and one patient discontinued cryotherapy.

The sample size was small sample, and the control group was based on historical reports.

To evaluate the effect of an increased duration of aprepitant for the prevention of chemotherapy-induced nausea and vomiting (CINV)

Women scheduled to receive AC regimens (doxorubicin and cyclophosphamide) enrolled in the study were randomly assigned to two groups. One group received a three-day aprepitant regimen in the first course of chemotherapy and six days in the second course. The other group received six days of aprepitant in the first course and three days in the second course of chemotherapy. All patients also received 8 mg dexamethasone IV on day 1 followed by 80 mg dexamethasone daily. During the six day course, dexamethasone was given for six days, and on the three-day regimen, it was given for three days. A 30-day washout existed between courses. Study measures were done at baseline for both chemotherapy cycles and seven days later.

• N = 49
• MEAN AGE = 38.7 years (SD = 6.5)
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: All had breast cancer.
• OTHER KEY SAMPLE CHARACTERISTICS: No indication of patients being chemotherapy naive

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

• PHASE OF CARE: Active antitumor treatment

• Randomized, controlled, crossover trial

• Eastern Cooperative Oncology Group (ECOG) toxicity questionnaire 
• Complete response (CR) defined as no nausea and no episodes of vomiting

Sixty-three percent had CR with the six-day regimen compared to 39% with the three-day regimen (p < 0.001). The order of treatment regimens did not affect results.

The use of aprepitant and dexamethasone for six days was more effective than a three-day regimen for the prevention of CINV.

• Small sample (< 100)
• Risk of bias (no blinding)
• Measurement validity/reliability questionable
• The ECOG questions for nausea have questionable validity for symptom measurement.
• No 5-HT₃ was administered, which is recommended for AC regimens.

Findings suggest that the provision of an antiemetic regimen for a longer duration in patients receiving highly emetogenic chemotherapy may be more beneficial to prevent CINV than current three-day regimens. Further well designed research in this area would be helpful.

STUDY PURPOSE: To discuss the usefulness and safety of axillary reverse mapping (ARM) of the arm and breast during surgery on the development of breast cancer-related lymphedema

TYPE OF STUDY: Systematic review

PHASE OF CARE: Late effects and survivorship

This review showed that the ARM technique is feasible and can result in low rates of lymphedema, and identification of ARM lymphatics and nodes was higher with ANC than SNB. The rate of lymphedema during SNB was 0%–6% and 5.9%–24% during lymphatic preservation at ANC, both of which are still lower than previously stated rates. Ochoa et al. reported a lymphedema rate of 2.5% for SNB alone and 2% with ARM. Casabona et al. reported no cases of lymphedema. Crossover nodes were identified in four studies assessing ARM in SNB, two of which were metastases. Kuusk et al. identified 1/ 5 nodes, and Ochoa et al. identified 2/14 nodes, thereby suggesting that crossover nodes are not common during ARM and however many metastases are present (0%–20%). Metastases were detected at the same rate (0%–19%) in patients where ARM nodes were not preserved when identified. Ochoa et al. reported 5/27 ARM positive nodes and Han et al. reported 2/17 positive ARM nodes during SNB, while Tausch et al. identified 13/58 metastases ARM nodes during ANC.

• Limited search
• Low sample sizes
• Short follow-up intervals did not allow a long enough interval to establish the oncologic safety of ARM
• Standard SNB technique was not used in all studies.
• Different definitions of lymphedema
• Clinical diagnoses of lymphedema were made occasionally.
• Inconsistent knowledge of number of nodes excised and if patients were undergoing adjuvant

The implications for nursing would be in the area of low-level laser therapy (LLLT) patient education, understanding of the ARM technique, and evidence related to lymphedema rate. For the present, nurses need to be knowledgeable of clinical trials involving the ARM technique and stay current with lymphedema management.

To determine whether oxycodone/naloxone prolonged-release tablets (OXN PR), as compared with oxycodone prolonged-release tablets (OxyPR), can improve constipation and maintain analgesia in patients with moderate or severe chronic cancer pain.  

Stopping their prestudy opioid and laxative medication, eligible patients were randomized to receive one of two treatments, OXN PR or OxyPR, for a four-week double-blind treatment phase. After beginning the study, patients attended three additional clinic visits, once weekly. Oxycodone immediate-release capsules were available as pain rescue medication and bisacodyl tablets were available as laxative rescue medication. Evaluations of bowel function, pain control, use of rescue medication, and use of laxative medication during the prior seven days were performed at each clinic visit. Quality-of-life (QOL) assessments were conducted at screening and study end.

• In this sample, 133 of 184 patients (72.3%) completed the study.
• Patients were aged 18 years or older. Mean patient age was 61.86 years (SD = 10.93, median = 62, range 36-84) in the OXN PR group and 64.3 years (SD = 9.63, median = 66, range 42-82) in the OxyPR group. 
• The OXN PR group was 52% male and 48% female, whereas the OxyPR group was 50% male and 50% female.
• Key disease characteristics were having a diagnosis of cancer and moderate or severe, chronic pain requiring around-the-clock opioid therapy, with constipation induced or worsened by the opioid medication.
• Patients were excluded if they had clinically unstable disease; significant cardiovascular, renal, hepatic, or psychiatric disease; clinically significant gastrointestinal (GI) disease; significant structural abnormality of the GI tract; cyclic chemotherapy within two weeks before the screening visit; planned chemotherapy during the study; or radiotherapy that would influence bowel function or pain.

• Multi-site
• Outpatient
• International  (64 study sites in Australia, Czech Republic, France, Germany, Hungary, Israel, Netherlands, Poland, and United Kingdom)

Patients were undergoing the active treatment phase of care.

This was a randomized, double-blind, active-controlled, double-dummy, parallel-group, phase II trial.

• Bowel Function Index (BFI)
• Brief Pain Inventory (Short Form) (BPI-SF)
• EuroQol EQ-5D
• European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30)
• Patient Assessment of Constipation Symptoms (PAC-SYM)
• Modified Subjective Opiate Withdrawal Scale (SOWS)
   

• Mean BFI score was significantly lower in the OXN PR group (p ˂ 0.01) after four weeks of treatment.
• Mean total laxative intake was 20% lower in the OXN PR group, but the difference was not statistically significant (p = 0.17).
• Mean BPI-SF scores and analgesic rescue medication use were similar for both groups.
• The OXN PR group had greater improvements in constipation-specific QOL assessments in terms of total symptom score (p = 0.014) and frequency of symptoms (p ˂ 0.01).
• Adverse events were similar and low in both groups.

OXN PR, as compared with OxyPR, seems to provide comparable analgesia for patients with moderate or severe cancer pain while significantly improving bowel function and reducing symptoms of constipation.

Demographic characteristics were generally well balanced between treatment groups, with the exception of a slightly higher percentage of patients aged 65 years or younger in the OXN PR group. 

OXN PR seems superior to OxyPR with respect to bowel function by reducing constipation without compromising pain relief. In addition, patients receiving OXN PR had improved QOL with decreased opioid-induced constipation complications.

To answer the following questions: What are the effects of oral laxatives, rectal preparations, and opioid antagonists for constipation in people prescribed opioids?

Databases searched were MEDLINE, Embase, Cochrane Central Register of Controlled Trials and Library, NHS Centre for Reviews and Dissemination (CRD), Database of Abstracts of Reviews of Effects (DARE), Health Technology Assessment, TRIP, and the National Institute for Health and Clinical Excellence (NICE) up to August 2009. Alerts from the U.S. Food and Drug Administration and the U.K. Medicines and Healthcare Products Regulatory Agency were included to identify any adverse effects.

Search keyword were constipation and opioids, Lactulose, macrogols, senna, bisacodyl, co-danthrusate/co-danthramer, docusate, ispaghula husk, liquid paraffin, magnesium salts, methylcellulose, arachis oil enema, glycerol suppository, phosphate enema, sodium citrate enema, and opioid antagonists.

Studies were included in the review if they

• Were randomized controlled trials (RCTs), observational studies, or systematic reviews
• Had a study sample of at least 20 participants
• Had a maximum loss to follow-up of 30% per year in longitudinal studies.

The GRADE System was used to evaluate study quality. Full information is available online with a subscription.

The final sample comprised 23 systematic reviews, RCTs, or observational studies. This was an update of a previous review that added 1 systematic review and 5 RCTs, with no change in overall recommendations provided.

Oral Laxatives

• Lactulose, polyethylene glycols (PEGs) plus electrolytes, and senna were identified as beneficial in this systematic review. Evidence in this area was graded as low-to-moderate quality. Lactulose appears to be as effective as PEG in reducing the number of hard stools, and as effective as senna in reducing the number of days without defecation.
• Preparations identified as unknown effectiveness included bisacodyl, co-danthrusate and co-danthramer, docusate, ispaghula husk, liquid paraffin, magnesium salts, and methylcellulose.
• Some oral laxatives such as bisacodyl often are prescribed in combination with other agents or rectal suppositories, but no evidence supports this use, particularly in people taking opioids.
• Liquid paraffin may be harmful in patients who have difficulty swallowing.

Rectal Preparations

• All of the rectal preparations studied were categorized as unknown effectiveness. The preparations included arachis oil enema, glycerol suppository, phosphate enema, and sodium citrate micro-enema.

Opioid Antagonists

• Opioid antagonists, including alvimopan, methylnaltrexone, and naloxone, were categorized as beneficial.  Categorization was based on studies comparing those agents to no treatment or placebo.  The most common side effects reported were abdominal pain, nausea, and diarrhea, particularly with higher doses. 
• A concern with these agents is the potential for use to reverse the therapeutic action of opioids.  Alvimopan and methylnaltrexone are considered safer than naloxone in this regard, as neither of those agents can cross the blood-brain barrier and a few small studies of acute pain have shown success in blocking the constipating effect of opioids without compromising pain relief.

• Although various combinations of oral laxatives and rectal agents may be used clinically, their effectiveness for constipation in people taking opioids has not been evaluated. This area can benefit from continued well-designed study.
• Opioid antagonists are considered effective for reducing constipation in people prescribed opioids. However, only a few studies with small groups of patients have examined the effect of these agents on pain relief with opioids. Use of opioid antagonists may also have implications for which type of opioid should be used for pain control.  Long-term use with chronic pain managed by opioids is not well researched.

Nurses should be aware of potential implications related to the use of opioid antagonists in controlling constipation for opioid interactions and changes in pain control. In addition, nurses should routinely assess for pain relief, as well as symptoms of constipation, in this patient population.

To determine whether oxycodone/naloxone prolonged-release tablets (OXN PR) can improve constipation and maintain analgesia, compared with oxycodone prolonged-release tablets (OxyPR) in patients with moderate to severe cancer pain

This was a randomized, double-blind, active-controlled, double-dummy, parallel-group study in which 185 patients were randomized to receive up to 120 mg per day of OXN PR or OxyPR over four weeks. Efficacy assessments included Bowel Function Index (BFI), Brief Pain Inventory Short-Form (BPI-SF), and laxative and rescue medication use. Quality-of-life and safety assessments also were conducted.

• N = 184
• AGE = In the OXN PR group, 65.2% of the patients were aged 65 years or younger and 34.8% were older than 65 years. In the OxyPR group, 48.9% of the patients were aged 65 years or younger and 51.1% were older than 65 years.
• MALES: 51%, FEMALES: 49%
• KEY DISEASE CHARACTERISTICS: Eligible patients aged 18 years or older with a diagnosis of cancer and a documented history of moderate to severe, chronic cancer pain requiring around-the-clock opioid therapy equivalent to OxyPR 20–80 mg per day at the initiation of the trial
• OTHER KEY SAMPLE CHARACTERISTICS: Willing and able to participate in the use of medication, complete subjective evaluations, attend scheduled clinic visits, complete telephone contacts, and comply with protocol requirements as evidenced by providing written, informed consent

• SITE: International
• SETTING TYPE: Multi-center
• LOCATION: Australia, Czech Republic, France, Germany, Hungary, Israel, Netherlands, Poland, and United Kingdom

• PHASE OF CARE: Active treatment
• CLINICAL APPLICABILITY: Palliative care

• Randomized, double-blind, active-controlled, double-dummy, parallel-group study

• Evaluations of BFI, pain control (BPI-SF), use of rescue medication, and use of laxative medication during the last seven days were performed at each clinic visit.
• Quality-of-life assessments, including the European Quality of life (EuroQo) EQ-5D instrument and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) were conducted at screening and at study end.
• Patient Assessment of Constipation Symptoms (PAC-SYM) was conducted at screening, randomization, and four weeks.
• Adverse events were noted at each assessment post-randomization.
• Patients were followed up regarding adverse events and adverse drug reactions after study completion.

Overall, 133 of 184 patients (72.3%) completed the study. Rates of discontinuation were similar for OXN PR (28.3%) and OxyPR (27.2%). In both groups, the primary reason for discontinuation was adverse events. At randomization, mean BFI values were high and comparable in the OXN PR and OxyPR groups (63.97 [SD = 17.42] versus 62.40 [SD = 23.56], respectively), and similar to baseline assessments in previous phase III trials. The difference in change from baseline in BFI score between groups was statistically significant. A statistically significant difference between treatments in favor of OXN PR was observed at week 1.

At randomization, mean BPI-SF scores were comparable for OXN PR and OxyPR treatment groups (4.16 [SD = 1.87] versus 4.18 [SD = 1.87]). After four weeks of treatment, mean BPI-SF scores remained comparable between the two groups (3.50 [SD = 1.88] and 3.52 [SD = 1.80]). Results of the primary analysis confirmed non-inferiority of OXN PR to OxyPR.

Patients who were switched directly from other opioids to OXN PR experienced a similar analgesic effect as well as a statistically significant and clinically relevant improvement in bowel function, compared with those switched to OxyPR.

Opioid-induced bowel dysfunction is common and adds to the burden of living with chronic pain. Current oral and rectal laxatives often are ineffective and do not have a good evidence base. The new targeted approach of administering peripherally acting opioid antagonists is effective and supported by extensive clinical trial data. The present trial demonstrates that oral OXN PR tablets are well tolerated and can effectively and conveniently provide targeted treatment of opioid-induced constipation.

The study is a double-blind, randomized, controlled phase ll trial of heliox 28 gas mixture in patients with lung cancer with dyspnea on exertion.

The study compared the effects of heliox 28 (72% helium and 28% oxygen) to oxygen-enriched air (72% nitrogen and 28% oxygen) or medical air (78.9% nitrogen and 21.1% oxygen) on dyspnea and exercise capacity in patients with lung cancer.

The study reported on a sample of 12 patients with lung cancer; patients had to be able to do a six-minute walk prior to screening evaluation and at defined time points throughout the study.

The study was a double-blind, randomized, controlled phase ll trial.

Patients’ symptoms were evaluated with a VAS and modified Borg scale (0–10). Pulse oximetry (SaO₂) monitoring was done continuously before, after, and then for five minutes after patients breathed the gas mixture.

Dyspnea assessments and VAS scores indicated a significant decrease in breathlessness following heliox 28 compared to medical air. No significant difference was found between heliox and oxygen-enriched air. Borg assessments showed no significant differences across treatments. Patients receiving heliox 28 walked farther than patients receiving oxygen-enriched air or medical air (p < 0.001). No significant difference was found in oxygen saturation percentage measured before the walk. Oxygen saturation was significantly higher during the walk and at rest after breathing heliox 28 than with the other two gas mixtures (p < 0.0001). No significant difference was found between oxygen-enriched air and medical air. No adverse events were reported.

The study had a small sample size of 12.

A promising beneficial role may exist for heliox therapy to improve exercise tolerance in dyspneic patients with cancer.

To compare transdermal fentanyl and sustained-released morphine in palliative care patients with cancer by measuring efficacy, tolerance, and quality of life (QOL).

Patients received one treatment for 15 days, then the other for 15 days to compare which provided the greatest efficacy and QOL, and the fewest side effects. The null hypothesis was 50% of patients would prefer fentanyl and 50% would prefer morphine.

• The study reported on a sample of 202 adult palliative care patients with cancer; 110 completed the study.
• Mean patient age was 61.5 years.
• The sample was 55% male.
• Patients had a life expectancy greater than a month and were receiving a strong, stable dose of opioids.

38 different palliative care centers in the United Kingdom

This was a randomized, open, two-period, crossover study.

• QOL was assessed with World Health Organization (WHO) performance status (measured prestudy, post-study, and daily during the study) and the European Organization for Research and Treatment of Cancer (EORTC) QOL questionnaire, which measures side effects, convenience, and effects on activities of daily living (ADLs) or careers (measured after each arm of the study). These tools have been validated for patients with advanced cancer. 
• Constipation and diarrhea were assessed with the EORTC scale prestudy and on days 8, 16, 23, and 31. 
• Daily diaries were used to record estimated sleep length, night awakening, daytime drowsiness, and use of rescue medications.
• Memorial Pain Assessment Card was used BID for assessment of pain and mood.
• Skin assessment was performed when removing patches.

• The top reason patients withdrew from the study was because of adverse events.
• Fentanyl was associated with significantly less constipation than morphine (p <  0.001). This was confirmed through multiple assessment mechanisms.
• The remaining results did not pertain to constipation.

• Patients were allowed short-acting morphine for breakthrough pain, which could alter the results for fentanyl; however, the results were still significant.
• Having a \"washout\" period is unethical.
• Some patients may have dropped out because of morphine withdrawal.
• The study was not blinded; therefore, bias may exist according to delivery mechanism preference.
• Fentanyl and morphine doses varied among individuals and were titrated, as needed, throughout the study.