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.

To compare the efficacy of continuous wound infiltration with a local anesthetic with thoracic paravertebral block after breast surgery

Before surgery, patients were randomized to receive an ipsilateral paravertebral block or postoperative continuous wound infiltration with 0.5% ropivacaine. Two catheters delivered ropivacaine at a 2 m/L rate for each catheter. Pain assessments were done every four hours. All patients received the same anesthesia protocol.

• N = 48
• MEAN AGE = 65.5 years
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: All patients had breast cancer and were receiving modified radical mastectomies.

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

• PHASE OF CARE: Active antitumor treatment

Randomized, parallel-group trial

• Visual Analog Scale (VAS) for pain
• Analgesia consumption
• Restricted movement because of pain

Patients in the paravertebral block group had lower pain scores and less restriction of shoulder movement in the first four hours (p < 0.005), and at 16–24 hours, patients  in the continuous wound infiltration group had lower pain scores (p < 0.02). There were no differences between groups in overall analgesic consumption. The incidence and severity of postoperative nausea and vomiting were higher in the wound infiltration group (p = 0.017). Median pain scores were low across all time points.

Both paravertebral blocks and continuous wound infiltration were effective for the management of postoperative pain. Although pain was lower in patients receiving continuous infiltration at later hours of observation, their incidence of postoperative nausea and vomiting was higher.

• Small sample (< 100)
• Risk of bias (no blinding)

Both neural blocks and continuous wound anesthetic infusions were effective methods for postoperative pain management in this study although wound infiltration was associated with more nausea and vomiting. Nurses need to consider the potential for postoperative nausea and vomiting associated with pain control interventions as well as the anesthetics used.

To determine if ondansetron or granisetron is more effective at alleviating chemotherapy-induced nausea and vomiting (CINV) in children with acute lymphoblastic leukemia (ALL)

Children receiving high-dose methotrexate were randomized to receive ondansetron (4 mg) or granisetron (1 mg) orally in 5 ml of water 30 minutes before chemotherapy infusion. Pills were crushed and stored prior to distribution. Patients could receive an additional dose of the drug within 24 hours for moderate vomiting. Patients were assessed at baseline before the infusion and every 24 hours after chemotherapy. Patients did not have any antiemetic drugs in the 24 hours preceding chemotherapy infusion.

• N = 60
• AGE: Range = 4 - 11
• MALES: Not reported
• FEMALES: Not reported

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

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Pediatrics

RCT, double-blind

• Modified Morrow Assessment of Nausea and Emesis (MANE) scale
• Complete Blood Test (CBC)
• Serum creatinine
• Serum alanine aminotransferase (ALT) test

Children in the ondansetron group had a 70% complete response and a 30% partial response to acute CINV (24 hours following infusion). Children in the granisetron group had a 90% complete response and a 10% partial response to acute CINV. There was a significant difference between the group for acute CINV (p < 0.05). Of the children receiving ondansetron, 58.6% had a complete response to delayed CINV and 41.4% had a partial response on day 3, whereas 86.7% in the granisetron group had a complete response and 13.3% had a partial response to delayed CINV on day 3. The difference between groups was significant (p < 0.01). Results on day 4 were similar, with 58.6% of children in the ondansetron group experiencing a complete response and 37.9% experiencing a partial response while 96.7% had a complete response and 3.3% had a partial response in the granisetron group. These results were also significant (p < 0.01). Thirty percent of children receiving ondansetron received additional drug compared to 3.3% in the granisetron group (p < 0.01).

In children with ALL, granisetron is more effective at alleviating both acute and delayed CINV in patients who are on high-dose methotrexate.

• Small sample (< 100)
• Findings not generalizable
• Other limitations/explanation: Sample characteristics were not reported. It is unknown if there are group differences.

Nurses can advocate for the use of granisetron rather than ondansetron in children who are receiving highly emetic chemotherapy infusions. Granisetron may be more effective for both acute and delayed CINV.

To evaluate the effectiveness of a nurse-led telephonic psychoeducational intervention on caregiver strain and burden

Patients were randomized to receive the study intervention or usual care. In the intervention group, caregivers received structured telephone calls at two, four, and eight weeks after hospital discharge from colorectal nurse specialists. Calls were used to identify caring problems or psychological issues, provide related information, educate caregivers according to patient needs at different stages of recovery, and provide support. A checklist for the telephone call was used, and nurses compiled field notes during the calls. These were reviewed to ensure intervention accuracy and consistency. Usual care patients received an information sheet for home care education on discharge and were provided with a telephone hotline number. Study data were collected via phone interview.

• N = 135  
• MEAN AGE = 54 (range = 19–86 years)
• MALES: 25.7%, FEMALES: 74.3%
• KEY DISEASE CHARACTERISTICS: All had colorectal cancer; 31% had colostomy; about half of the sample were to receive adjuvant chemotherapy
• OTHER KEY SAMPLE CHARACTERISTICS: The largest proportion of caregivers were wives, and the next most frequent caregivers were daughters; 13.6% had education beyond secondary school level; most had low incomes

• SITE: Single site    
• SETTING TYPE: Home  
• LOCATION: Hong Kong

• PHASE OF CARE: Multiple phases of care

Single, blinded, randomized, controlled trial

• Depression, Anxiety, and Stress (DASS) scale 
• Zarit Burden Interview (ZBI)
• World Health Organization Quality of Life (WHOQOL-BREF) measure 

Main concerns of the caregivers were dietary advice, chemotherapy advice, and the management of wounds, bowel function, and pain. Depression and anxiety declined over time in all subjects. At two and four weeks, the reduction in depression scores was greater for those in the intervention group (p = 0.013 and p < 0.001, respectively). The mean decline in anxiety scores was greater in the intervention group at two and four weeks as well (p < 0.004). Psychological health scores improved more for those in the intervention group (p < 0.007). Scores for care burden declined more for the intervention group at all follow-up periods (p < 0.001). Baseline depression and anxiety scores were mild. There were significant group-by-time effects for depression, care burden, psychological health, and social relationships.

The findings of this study demonstrated the effectiveness of this nurse-led telephonic psychoeducational intervention to reduce caregiver burden.

• Risk of bias (no appropriate attentional control condition)  
• Risk of bias (sample characteristics)
• Other limitations/explanation: Possible testing effect with repeated measures using the same study instruments; the sample was all patients with colorectal cancer, and issues and findings may not apply to other groups; initial calls were mainly focused on issues such as wound care; it is not clear what the timing of chemotherapy was in relation to the intervention

This study showed that the provision of telephonic psychoeducation for caregivers was effective in reducing caregiver burden. The intervention also may benefit in terms of symptoms of depression and anxiety. However, the initial levels of these symptoms were not indicative of a clinically significant problem, and results declined in all caregivers over time. The provision of a telephonic intervention by nurses can be an effective and practical method of providing education and support to caregivers.