• FINAL NUMBER STUDIES INCLUDED = 13 
• TOTAL PATIENTS INCLUDED IN REVIEW = 88
• SAMPLE RANGE ACROSS STUDIES: 1–35 patients
• KEY SAMPLE CHARACTERISTICS: Two randomized, controlled trials ([RCTs] one RCT only had a sample size of two patients), two nonrandomized before–after studies, and nine case studies; majority of patients were inpatients with lung cancer or chronic obstructive pulmonary disease and constant or episodic (four studies) breathlessness receiving fentanyl (oral, IV, or transdermal) 

PHASE OF CARE: Multiple phases of care 

APPLICATIONS: Elder care, palliative care

All studies reported the successful relief of breathlessness after fentanyl application, but the only RCT (N = 12) failed to demonstrate a statistically significant difference when fentanyl was compared to a placebo. The nature and incidence of fentanyl-related adverse events such as somnolence and dizziness were comparable to other opioids, and no respiratory depression was observed.

There is no conclusive evidence about use of fentanyl to relieve breathlessness because of the lack of sufficiently powered, controlled studies. The descriptive and quasi-experimental studies included in this review show promising results for the use of fentanyl for breathlessness. All studies reported an improvement in breathlessness, but a fully powered RCT to conclusively determine the effect of fentanyl on breathlessness is warranted.

The descriptive and quasi-experimental studies included were at-risk for bias because of the lack of a control. The doses of fentanyl varied considerably, which limits conclusions about the appropriate dose. Missing data included the time of response after the administration of fentanyl, which is important when comparing fentanyl to other opioids.

The clinical experience of fentanyl for breathlessness is promising. Considering emerging data, which suggests that breathless episodes often last less than 10 minutes, the current standard (immediate-release morphine) has a longer onset of action than the symptom episode duration. Fentanyl's time of onset still is unknown, but it may better match the characteristics of breathlessness episodes, which is clinically important.

To analyze the effect of different protocols of laser phototherapy (LPT) on the grade of mucositis and the degree of pain in patients undergoing radiation therapy

Patients were divided into three groups. One group was treated with low-dose laser therapy three times per week. Group 2 received combined high and low powered lasers used three times per week. The third group received low-level laser therapy (LLLT) once weekly. Oral mucositis and pain were assessed at the first visit and at each LPT visit.

• The study consisted of 39 patients whose ages ranged from 15–79 years.
• The sample was 38% female and 62% male.
• Patients had been diagnosed with head and neck cancer and were receiving radiation therapy, chemotherapy, or both.

This was a single-site study conducted at the Cancer Hospital of Mato-Grasso, Brazil.

This was a prospective clinical trial.

• A visual analog scale (VAS) was used to measure severity of oral pain.
• The National Cancer Institute (NCI) Common Toxicity Criteria (CTC) for radiation-induced oral mucositis scale was used.

No differences were found between groups in overall grades of mucositis. Pain increased in the patients that received LPT weekly (p = 0.01), while pain severity remained about the same over time in other groups. Patients who received combined high and low power laser took significantly more time to heal (p = 0.04).

LPT using low power laser alone or in combination with high powered lasers when applied three times weekly maintained the mucositis grades at levels I and II and prevented increased pain. Combination low and high power laser treatment was associated with a longer time to healing mucositis.

• The sample size was small with fewer than 100 patients.
• No control group was included.

This study provides an initial look at differences in outcomes with LPT based on different dosages and types of LPT treatment. Further research in this area, as well as studies looking at timing differences in the phase of care, are necessary to determine the most effective use of this treatment modality.

To investigate the effects of Bryophyllum pinnatum (B pinnatum) on sleep quality in patients with cancer

B pinnatum is an herbal medicine previously found to improve sleep quality in pregnant women. Patients were included in the review of records if they were diagnosed with cancer and had been prescribed B pinnatum 50% (350 mg tablets at varying dosages) for at least 21 consecutive days for sleep-wake disturbance. The tablets contained 50% leaf-pressed juice on lactose, and dosages ranged from three to eight tablets per day. Study assessments were done at baseline and on day 22.

• N = 20
• MEAN AGE = 61 years (SD = 10.4 years)
• MALES: 15%, FEMALES: 85%
• KEY DISEASE CHARACTERISTICS: Various cancer types with the majority being breast cancer; average time since diagnosis was five years
• OTHER KEY SAMPLE CHARACTERISTICS: The majority of women were postmenopausal, and the duration of sleep problems was an average of two years. 65% of participants received previous therapy with mistletoe.

• SITE: Single-site  
• SETTING TYPE: Outpatient    
• LOCATION: Switzerland

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

Retrospective, observational study

• Pittsburgh Sleep Quality Index (PSQI)

During treatment with B pinnatum, sleep quality improved from a mean PSQI score of 12.2 (SD = 3.62) to 9.1 (SD = 3.61) (p = 0.002). Improvement was seen in sleep latency and habitual sleep efficiency (p < 0.03). Patients receiving B pinnatum took fewer sleep medications. In most cases, patients took two tablets twice daily. There were very few minor side effects, and no severe adverse reactions were reported. One patient reported an improvement in hot flashes.

B pinnatum may be helpful in the management of sleep disturbances in patients with cancer.

• Small sample (< 30)
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)

The findings of this study suggest that B pinnatum may be helpful for patients with cancer who have insomnia; however, evidence is weak because of study design limitations and the small sample size. The positive findings seen here suggest that additional research on the use of B pinnatum is warranted.

STUDY PURPOSE: To assess the effectiveness and safety of 5HT3s for antiemetic prophylaxis

TYPE OF STUDY: Meta-analysis and systematic review

• FINAL NUMBER STUDIES INCLUDED = 25
• TOTAL PATIENTS INCLUDED IN REVIEW = 8,813
• SAMPLE RANGE ACROSS STUDIES: 23–542 patients
• KEY SAMPLE CHARACTERISTICS: Multiple tumor types

PHASE OF CARE: Active antitumor treatment

Meta-analysis of ondansetron versus granisetron or tropisetron did not show any significant differences in the risk of CINV. The risk ratio with palonosetron versus ondansetron was lower (–1.28, p = 0.033).

The findings suggested a similar efficacy of the various 5HT3 preparations for CINV prophylaxis.

Some regimens contained a steroid and some did not. Meta-analysis did not consider all possible drug combinations. Varied emetogenicity of chemotherapy regimens was present.

The findings support the general efficacy of various 5HT3 drugs for CINV prophylaxis.

This multimodal psychological sleep management program combined relaxation techniques (progressive muscle relaxation [PMR] or autogenic training [AT]; sleep hygiene; cognitive techniques; and advice) in stimulus control techniques. Outcomes were sleep and quality of life (QOL).

• Of the patients, 80 were in the PMR group, 71 were in the AT group, and 78 were in the control group.
• The study included a mixed sample of adults, with a mean age of 58 years, who predominantly had breast, kidney, or prostate cancer.

• Three to four weeks’ length of stay in an oncology rehabilitation clinic
• Germany

Patients were undergoing the long-term follow-up phase of care.

The study used a quasiexperimental design, with sequential recruitment of groups and patient choice for PMR or AT.

Pittsburgh Sleep Quality Index (PSQI), German Translation

No statistically significant difference was found between the PMR and AT groups. Improvement was noted in the intervention groups regarding sleep latency, sleep duration, sleep efficiency, sleep medication (decreased), and daytime dysfunction.

• Use of a validated tool validity of German translation was not addressed.
• The study was not randomized.
• Staff must be trained in AT, PMR, and other intervention techniques.

To determine whether patients with bone cancer pain who were already administered opioids obtain clinically important pain control with regular oxycodone/paracetamol

Patients received one to three placebo or oxycodone/paracetamol tablets four times per day for days 1–3, with the dosage titrated step by step based on pain assessment, up to 12 tablets per day, maximum. Patients recorded pain diary entries at baseline and on the study days. Immediate-release oral morphine was used to control breakthrough pain with 10% dose increments of the background continuous-release opioid, with no maximum (these were dispensed to the patient at the beginning of the study with specific instructions on administration). Patients remained on current background analgesic management, and additional analgesic drugs could be used, but not altered, during the study period.

• A total of 246 patients began the trial, with 225 completing the three-day study.    
• Patient age range was 28–84 years.
• Of the sample, 122 were male and 124 were female.
• Patients had malignant solid tumors with bone metastasis confirmed via imaging, had bone-related pain rated as 4 or higher on an 11-point pain scale, and had received treatment with controlled-release morphine or transdermal fentanyl patches for one week or more. They had conscious mental status, the ability to take oral tablets, and were at least 18 years of age.
• Patients were excluded from the study if they had received chemotherapy, radiation, or endocrine or monoamine oxidase inhibitors within the previous 30 days (or during the study), had history of alcohol abuse or severe hepatic disease, or had received nonsteroidal anti-inflammatory drugs or paracetamol combinations.

• Multisite
• Home setting
• Beijing, China

The study has clinical applicability for late effects and survivorship, and end-of-life and palliative care.

The study was a multicenter, randomized, double-blinded, placebo-controlled trial.

• Pain Intensity Difference
• Short Form-6 Dimensions quality-of-life scale
• General impression of patient satisfaction with the treatment (five-point verbal rating scale, 0 = poor, 4 = excellent)
• Numerical rating score (11-point scale, 0 = no pain, 10 = worst pain imaginable)
• Qualitative data analyzed using chi-squared test
• Qualitative data analyzed using Fisher’s exact test

Prior to the study, 55.6% of the intervention group experienced breakthrough pain, while 50.8% of the placebo group did. After treatment, only 38% of the intervention group suffered breakthrough pain, while 58% of the placebo group did. The use of immediate-release morphine decreased from 50% to 27.8% in the intervention group while in the study, whereas the placebo group decreased from 46.7% pre to 43.3% in the same time frames.

When oxycodone/paracetamol is added to intermediate- or high-dose continuous-release opioids, patients with bone cancer pain experienced greater relief of pain.

The authors cite that the study was conducted on only Chinese patients and point to the need to consider other ethnicities. There is no analysis based on overall analgesic regimens used, and no full description of these.  Addition of this medication essentially increased the opioid dosing per day, so it is not clear whether this particular formulation was any more helpful than simple dosage increases.

This study is applicable to patients with bone cancer pain who experience significant breakthrough pain while taking relatively high doses of a continuous-release opioid. It is not clear from this study how this particular formulation fits into an overall pain management regimen because it did provide higher dosage of opioid. Increasing opioid dosages may have had the same effect.

To evaluate the safety and efficacy of conrolled-release (CR) oxycodone as first-line opioid treatment for moderate to severe cancer-related pain

Every 12 hours for 21 days, patients were treated with oxycodone CR monotherapy. Initial doses were individualized for each patient. Doses were up-titrated for 3–4 days until the treatment achieved effective pain control. Effective pain control was a pain-rating reduction of 30% or more, compared to the previous pain rating value, and by day 7 a reduction in pain value equal to or less than 3. Hospital- based medical practitioners collected data at baseline and on days 1, 3, 7, 14, and 21.

• The sample was composed of 334 patients.
• Mean patient age was 66 years (SD = 11 years). 
• Of all patients, 44.6% were female and 55.4% were male.
• The sample included a variety of cancer types, with the most frequent diagnoses being lung, breast, prostate, and colon cancer (37.9% of these cases included bone metastases).
• Of all patients, at study entry 62.8% had experienced cancer-related pain for three months or less. At study entry, all patients had a pain intensity rating equal to or greater than 4 and 72% had baseline pain equal to or greater than 7. Of all patients, 68.2% had been using NSAIDs or weak opioids for the relief of pain.

• Multisite
• Italy

Open-label observational trial

• Numeric rating scale (0–10), to measure pain
• Short-Form Health Survey, 36 items (SF-36)
• Data related to adverse events, as recorded by clinicians

Pain intensity decreased consistently throughout the 21-day trial period, and the study drug achieved a significant decrease in pain intensity after just one day of treatment (p = 0.00001). Clinicians had to increase the dose over the course of the study, beginning with a mean dose of 22.84 mg/day on day 1 to a mean of 40 mg/day by day 21. Four patients discontinued treatment because of uncontrolled pain, which may have been the result of lack of dose escalation. Treatment with oxycodone CR improved quality-of-life parameters by 48%–63%, with the greatest improvement being in sleep quality and concentration. Drug-related adverse events were reported in 4% of patients and were of mild to moderate intensity. Nausea, vomiting, and constipation were the most common drug-related adverse events.

Oxycodone CR, provided as first-line treatment for moderate to severe cancer pain, was safe and effective.

• The study had a risk of bias due to no appropriate control group.
• Authors did not discuss the presence, absence, or treatment of breakthrough pain.

The World Health Organization and European Association of Palliative Care, among others, recommend that immediate-release formulations of strong opioids be titrated. This recommendation is based on consensus expert opinion rather than evidence from clinical trials. This study demonstrates that controlled-release formulations can be titrated. The results may be rapid response and significant reduction in pain intensity. In addition, in this study pain relief provided by oxycodone CR was associated with improved sleep quality.

 To identify the evidence in scientific literature related to nonpharmacologic interventions for the treatment of chemotherapy-induced nausea and vomiting (CINV)

Databases searched were Cochrane, PubMed, Latin American and Caribbean Health Sciences Literature (LILACSO), and Brazilian Nursing Database (BDENF).

Search keywords were nausea, vomiting, chemotherapy, nursing care, cursing care protocols for cancer chemotherapy, and chemotherapy induced nausea and vomiting.

Studies were included in the review if they

• Addressed nonpharmacological interventions for nausea and vomiting.
• Were completed within the past 10 years (1998–2008).
• Were conducted in English or Spanish.

• An initial set of 111 articles were identified. Of these, 102 were related to pharmacological management and were eliminated. A final sample of nine studies was included in the review.
• The authors developed an instrument to analyze the literature related to method, journal type, and author.
• The articles were published in English (78%), Portuguese (11%), and Spanish (11%).
• The majority of the articles (67%) were written by physicians in collaboration with psychologists and pharmacists.

• Across the nine studies, a total sample of 1,635 patients were studied.
• The majority of studies involved the use acupuncture, acupressure, or electroacupuncture (5 trials and 1 meta-analysis).
• Studies involved patients receiving highly emetogenic chemotherapy or those with refractory CINV.

• One of the studies involved patient dietary education and adherence to antiemetic therapy in which patients reported a better sense of security with the provision of written information.
• One study, which had 16 participants, found hypnosis to be effective in reducing anticipatory CINV.
• One randomized, controlled trial of 62 patients using a yoga program showed no decrease in frequency or intensity of CINV with the intervention.
• Findings among studies of acupuncture and acupressure had mixed results, with most showing no significant difference in symptoms with the intervention.
• The meta-analysis showed a reduction in the proportion of patients with acute vomiting but not in the severity of nausea.
• Electrical stimulation did not improve results.

This review demonstrated no substantial effects among the interventions included. Findings regarding the use of acupuncture, acupressure, and electroacupuncture were mixed. Most studies using acupuncture and acupressure involved use of the p6 point on the wrist.

This review included a limited number of studies.

The evidence does not demonstrate significant effect of these interventions for CINV. However, these interventions may be useful as adjuncts to pharmacologic treatment. Nonpharmacologic interventions appear to be most effective in the prevention of acute vomiting rather than symptoms of nausea.

STUDY PURPOSE: To evaluate the efficacy and safety of drugs reported in randomized controlled trial for the management of opioid-induced constipation

• FINAL NUMBER STUDIES INCLUDED = 21 studies included in qualitative synthesis, 14 analyzed in quantitative synthesis 
• TOTAL PATIENTS INCLUDED IN REVIEW: methylnaltexone: 1760, naloxone: 798, alvimopan: 1525, naloxegol: 1545, lubiprostone: 877, CB-5945: 131, prucalopride: 196
• KEY SAMPLE CHARACTERISTICS: Opioid constipation

PHASE OF CARE: Active antitumor treatment
 
APPLICATIONS: Palliative care

Efficacy: Methylnaltrexone OOM were examined in seven studies. Averaged over all the studies, responder rated reached 30%. Median time to rescue-free bowel movement (RFBM) was shortest for doses 0.15 mg/kg and 0.3 mg/kg compared to placebo. Naloxone: Four studies' group differences were significant, but the mean difference of less than or equal to 0.5 and the one-week and four-week comparison was small.  Noloxegel: Three studies with responder rates after 12 weeks of treatment were significantly higher for the 25 mg group, and there was no difference between noloxegel and the placebo group at 12.5 mg. Lubiprostone: Two RCTs showed results not consistent across studies. CB-5945: One study and statistical significant results for all BM frequency only in 0.25 mg bid versus placebo group. Pruclopride: One study with little statistical significance.  Alvimopan: Three studies; after 12 weeks there were spontaneous bowel movement (SBM) in both intervention groups with statistical significance and improvement also.

Seven novel drugs for OIC were reviewed. Effectiveness was shown for all drugs, but BM frequency measures hindered comparison of the studies and the drugs.

The authors used different terms in their inclusion criteria for outcome analysis. Seven drugs were included in the review. Comparing seven drugs made comparisons difficult and conclusions limited.

Improvement in management of OIC could improve patient experience, reduce hospital stays, and decrease patient suffering. Nurses should ensure preventive and proactice measure for their patients on opioids.

To evaluate effects of an electronic-based educational program with knowledge feedback for patients undergoing radiation therapy

Patients scheduled to begin RT were randomized to receive either usual care and education (control group) or usual education and care along with the experimental program. Patients in the experimental group received a link to the program that delivered statements for patient response, demonstrating their knowledge of the general RT process, side effects, self-care, and lifestyle. Patients were given immediate feedback of their knowledge based on responses given to 28 statements. Usual care involved face-to-face education at the time of treatments. Study measures were obtained before beginning RT, after completion of RT, and three months later.

• N = 115
• MEAN AGE = 57.6 (range = 18-75)
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: All had breast cancer. Significantly more in the intervention had lumpectomy rather than mastectomy
• OTHER KEY SAMPLE CHARACTERISTICS: More than half of the sample had some post-high school education. Eighty percent also were receiving chemotherapy

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

• PHASE OF CARE: Active antitumor treatment

• Single blind randomized, controlled trial

• State Trait Anxiety Inventory
• Functional Assessment of Cancer Therapy-Breast (FACT-B) for quality of life

Anxiety declined over time in both groups, and showed significant decline between baseline and measures at the end of RT.  Anxiety declined significantly in the experimental group from baseline to three months (p < 00001).  The decline in the control group was not significant, and there was no significant difference between groups.

The education feedback program may help to reduce anxiety in patients receiving radiation therapy, but was not more effective than usual care and education.

• Baseline sample/group differences of import
• Risk of bias (no blinding)

The provision of patient feedback regarding knowledge of treatment and aspects of self-care was delivered in this study via a Web-based program. This might be an effective way to reinforce patient education.