Miya, T., Kobayashi, K., Hino, M., Ando, M., Takeuchi, S., Seike, M., . . . East Japan Chesters Group. (2016). Efficacy of triple antiemetic therapy (palonosetron, dexamethasone, aprepitant) for chemotherapy-induced nausea and vomiting in patients receiving carboplatin-based, moderately emetogenic chemotherapy. Springerplus, 5, 2080-016-3769-x.
To assess the efficacy of triple drug antiemetic prophylaxis for patients receiving moderately emetogenic chemotherapy (MEC)
Patients receiving MEC containing carboplatin were treated with standard triple drug antiemetic therapy of palonosetron, dexamethasone, and aprepitant. Patients were assessed from the beginning of chemotherapy to day 7.
PHASE OF CARE: Active antitumor treatment
Prospective, observational
No patient vomited within the first 24 hours after chemotherapy. For the delayed and overall phases, completed response was seen in 91.9% of patients. Complete control was seen in 88.9%–97.8% across study days. The lowest rate of complete control was seen on day 3. Men tended to have a high prevalence of complete response and complete control. Hypertension of grade 3, which may have been related to the study drugs, was seen in five patients. Comparison to findings from five other studies showed high complete response rates in the present study.
Triple drug therapy for the prevention of chemotherapy-induced nausea and vomiting (CINV) was shown to be very effective for patients receiving MEC.
Triple antiemetic therapy is recommended in several professional guidelines for highly emetogenic chemotherapy but not for MEC. This study showed better efficacy for CINV control compared to some other studies in CINV management for MEC. Triple drug antiemetic prophylaxis should be considered for patients receiving MEC.
Miura, S., Watanabe, S., Sato, K., Makino, M., Kobayashi, O., Miyao, H., . . . Yoshizawa, H. (2013). The efficacy of triplet antiemetic therapy with 0.75 mg of palonosetron for chemotherapy-induced nausea and vomiting in lung cancer patients receiving highly emetogenic chemotherapy. Supportive Care in Cancer, 21(9), 2575–2581.
To evaluate the efficacy of triple antiemetic therapy consisting of a 0.75 mg dose of palonosetron, a three-day course of aprepitant, and four days of dexamethasone in the control of chemotherapy-induced nausea and vomiting (CINV) among chemotherapy-naïve patients with lung cancer undergoing highly emetogenic chemotherapy (HEC) regimens
From September 2010 to June 2012, patients received triplet antiemetic therapy (0.75 mg palonosetron IV + 9.9 mg dexamethasone IV + 125 mg of aprepitant orally) on day 1, followed by 80 mg aprepitant on days 2 and 3, and 8 mg dexamethasone on days 2–4.
Single-arm, phase II prospective, multi-centered, longitudinal trial
The triplet antiemetic therapy was the most promising regimen in preventing CINV in chemotherapy-naïve patients with lung cancer treated with HEC. The dose-response relationship between palonosetron and aprepitant use needs to be further investigated. However, the experience of nausea by almost half of the patients during the overall phase highlighted the necessity of conducting further investigations to control CINV during the delayed phase.
Although adding palonosetron to antiemetic regimens shows improvement more impressively in the acute phase among patients, caution should be taken before interpreting the result of this study as it did not use the most robust research design (of randomization, blinding, placebo control) to detect the drug's efficacy. Constipation is a commonly reported adverse effect in this study, therefore careful management should be considered when palonosetron is used.
Mitchell, S., Li, X., Woods, M., Garcia, J., Hebard-Massey, K., Barron, R., & Samuel, M. (2016). Comparative effectiveness of granulocyte colony-stimulating factors to prevent febrile neutropenia and related complications in cancer patients in clinical practice: A systematic review. Journal of Oncology Pharmacy Practice. Advance online publication.
PHASE OF CARE: Active antitumor treatment
Findings suggest that the use of long-acting CSFs was associated with a lower risk of FN, FN hospitalizations, and other related adverse patient outcomes.
Findings suggest that use of long-acting CSF may provide better prophylaxis for FN and FN-related events, but data and limitations of this review were insufficient to draw firm conclusions. Because of the variety of new biosimilar alternatives, additional work to determine comparative effectiveness and cost-benefit analysis of various formulations is increasingly important. This study does raise the question of what denominator is best used in outcomes measurement, whether outcomes should be viewed per patient, per cycle, or per patient-cycle.
Mitchell, G.K., Hardy, J.R., Nikles, C.J., Carmont, S.A., Senior, H.E., Schluter, P.J., . . . Currow, D.C. (2015). The effect of methylphenidate on fatigue in advanced cancer: An aggregated N-of-1 trial. Journal of Pain and Symptom Management, 50, 289–296.
To determine the efficacy of alleviating fatigue using the psychostimulant methylphenidate hydrochloride (MPH) in patients with advanced cancer
MPH 5 mg was taken orally twice daily versus placebo for three cycles of a pair of three-day periods. Patients completed a daily diary of symptom scales and side effects.
Population was estimated using the aggregated N of one multicycle, double-blinded, controlled, crossover study.
Eight patients had individual improvements in fatigue with MPH compared to a placebo on the FACIT-F and WCFS scores, but the mean population estimate showed no important difference. Seven patients showed an improvement in EDS scores, but the mean population estimate showed no important difference. There was no change in AKPS scores. There were six adverse events with three events possibly related to MPH.
Although there may be some individual improvement in fatigue with MPH use, the results of this small sample size were difficult to generalize.
Continued studies on the effects of psychostimulants on cancer-related fatigue are needed. This study adds to the growing body of evidence that methylphenidate is not generally helpful in reducing fatigue. The strength of this study's results are limited by design issues.
Mitchell, G.K., Girgis, A., Jiwa, M., Sibbritt, D., Burridge, L.H., & Senior, H.E. (2013). Providing general practice needs-based care for carers of people with advanced cancer: A randomised controlled trial. The British Journal of General Practice, 63(615), e683–e690.
To test whether a general practice consultation directed by a carer needs checklist would improve meeting the needs of carers
General practitioners of intervention patients were visited, introduced to intervention resources, and invited to participate. Tools provided were a needs assessment tool and a general practice toolkit of paper-based and electronic forms providing evidence-based information, resources, and services that might help address problems. Consultations were provided at baseline and at three months, based on needs assessment results. Patients were randomized, but those whose general practitioner had a previous participant were nonrandomly allocated to the same study group to prevent contamination. Data collection included survey at one, three, and six months by telephone interview. Control group general practitioners were not contacted. General practitioners were educated on the process through academic detailing.
Twenty-nine percent of intervention group patients and 15% of control group patients dropped out of the study—most said this was because they were too busy to continue after their initial interview. Three of 158 general practitioners refused to conduct the consultations. No between-group differences were seen in change from scores at baseline to scores at any time point. Subgroup analysis showed no change in depression scores. For those who were clinically depressed at baseline, control patients demonstrated significantly worse anxiety at six months, while intervention group scores were essentially stable. Intervention group carers with baseline anxiety or depression reported deterioration in physical scores on the SF-12 (p = .053). In analysis adjusted for baseline anxiety, those in the intervention group had significant worsening of physical function scores (p = .037) and increased psychological and emotional needs from baseline to three months (p = .033). Those caring for less ill individuals had improvement in mental health at three months in SF-12 scores.
The study did not demonstrate improvement in intensity or number of unmet needs or carer outcomes overall.
Findings did not support the idea of reducing carer unmet needs via an assessment-driven general practice consultation over time. Undergoing assessment of needs possibly increases the degree to which carers identify needs that are not being met. This study focused on provision of tools to general practitioners but does not describe what actions were taken on the basis of the assessment done, so it provides little support for any specific approach to address caregiver needs.
Misra, S., Parthasarathi, G., & Vilanilam, G.C. (2013). The effect of gabapentin premedication on postoperative nausea, vomiting, and pain in patients on preoperative dexamethasone undergoing craniotomy for intracranial tumors. Journal of Neurosurgical Anesthesiology, 25, 386–391.
To determine if prophylactically administered 600 mg oral gabapentin reduces postoperative nausea or emesis and decreases postcraniotomy pain
Patients to undergo elective craniotomy were randomized to receive either placebo (a vitamin b-complex capsule) or 600 mg oral gabapentin two hours before induction of anesthesia. All received standard antiepileptic prophylaxis with 100 mg phenytoin every eight hours and 4 mg IV dexamethasone every eight hours for 48 hours prior to surgery. Patients were given 1 gm IV paracetamol every six hours for postoperative pain. Rescue analgesia was provided with 1 mcg/kg IV fentanyl for a pain score of 3. Rescue antiemetic was provided with 4 mg IV ondansetron if the patient had any emetic episode or 10 minutes or longer of nausea. All received the same anesthesia. Symptoms were assessed hourly for the first six hours postoperatively and then every two hours for the next 18 hours.
Incidence of nausea was 35.1% in the placebo group compared to 11.1% in the gabapentin group (p = .02). No significant difference was seen between groups in incidence of emesis, but there was a trend to lower incidence of emesis with gabapentin. No difference was seen between groups in postoperative pain scores, the number of patients who required rescue analgesia, or postoperative fentanyl consumption.
Prophylactic oral gabapentin prior to surgery reduced postoperative nausea and vomiting in patients undergoing craniotomy. Perioperative gabapentin had no effect on postoperative pain.
Preoperative gabapentin may reduce postoperative symptoms of nausea and vomiting in patients undergoing craniotomy who are receiving dexamethasone perioperatively. The optimum dosage of gabapentin has not been determined.
Mishra, S., Bhatnagar, S., Goyal, G.N., Rana, S.P., & Upadhya, S.P. (2012). A comparative efficacy of amitriptyline, gabapentin, and pregabalin in neuropathic cancer pain: A prospective randomized double-blind placebo-controlled study. American Journal of Hospice and Palliative Care, 29, 177–182.
To compare the efficacy of amitryptylline, gabapentin, and pregabalin in patients with cancer experiencing neuropathic pain
Patients were randomly assigned to amitryptyllin (AT), gabapentin (GB), pregabalin (PG), or placebo. AT was given at 50 mg/day for one week, then increased incrementally to 100 mg/day. GB was given at 900 mg/day for one week in divided doses, then increased to 1,800 mg/day by week 3. PG was given at 150 mg/day for one week, then increased to 600 mg/day by week 3. The control group received placebo capsules. Morphine was used as rescue pain medication as needed. Patients were evaluated weekly for four weeks.
The study has clinical applicability for late effects and survivorship.
The study was a placebo-controlled, randomized trial.
VAS scores decreased in all groups. In week 4, those on pregabalin had significantly lower VAS scores than other groups, and scores declined by 4–5 points (p < 0.03). By the third visit, the percentage of patients who required morphine rescue increased: 46.7% with AT, 23.3% with GB, 16.7% with PG, and 100% with placebo. Lancinating pain incidence was lowest in the PG group. There were significantly fewer patients with dysesthesia in the PG group (6.7%) compared to the GB and placebo groups after four weeks. The percentage of patients with allodynia declined in all groups. The PG group showed a statistically significant improvement in ECOG score compared to all other groups (p < 0.001). Satisfaction was similar in all groups, and there were no significant differences in adverse reactions, with a gradual increase in all groups over time. Adverse effects were somnolence, dizziness, nausea, constipation, and dry mouth.
All of the drugs tested here demonstrated some efficacy in improving neuropathic symptoms. In several areas, it appears that pregabalin was more effective than gabapentin, opioid monotherapy, and amitryptylline. All medications were given in combination with opioids for pain management.
All of the medications examined in this study were effective and had a morphine-sparing effect in the treatment of neuropathic pain and other symptoms. Pregabalin was more effective than other alternatives tested in some areas. As all patients in this study received opioids for pain rescue, it should be noted that essentially all medications compared were given in combination with opioids.
Mishra, S., Bhatnagar, S., Rana, S.P., Khurana, D., & Thulkar, S. (2013). Efficacy of the anterior ultrasound-guided superior hypogastric plexus neurolysis in pelvic cancer pain in advanced gynecological cancer patients. Pain Medicine, 14, 837–842.
To evaluate the effect of anterior ultrasound-guided superior hypogastric plexus neurolysis in patients with gynecologic cancer with pelvic cancer pain
Patients were randomly divided into two groups. Group 1 received oral morphine for pain control, and group 2 had ultrasonography-guided superior hypogastric plexus neurolysis (SHPN). Oral morphine was given to both groups as rescue analgesia. The pain, functional capacity, global satisfaction score, and adverse effects were recorded.
No difference was seen between the two groups when comparing age, height, and wight (P > 0.05). Both groups showed a significant decrease in VAS pain sores at one week, one month, two months, and three months, and from baseline at each visit (P < 0.05). At three months, no significant difference was seen in VAS scores. No statistical difference was seen in baseline morphine consumption. Consumption declined from baseline in group 2 at the first week, but consumption increased at the rest of the time points. At the first week and month, rescue doses of morphine differed but not significantly for the last two visits. At week one, ECOG status was significantly better for group 2 (p = 0.002), and global pain was better at one month (p = 0.008), but by the end of the study, no statistical difference was seen. The global satisfaction score was better at dthe first week (p = 0.00) and first month (p = 0.04). Less adverse effects occurred in group 2 than group 1, but the difference was not statistically significant.
Ultrasonography-guided SHPN may be a potential intervention for patients with gynecologic cancer experiencing pelvic pain. This may be an option for those who cannot tolerate opioids or are experiencing adverse effects from long-term use of opioids. Although this intervention requires prep and fasting and is associated with its own adverse effects and risk, this may be an option for intervention. This study does not appear strong enough to replace opiate as the standard but rather supports the intervention as an adjuvant treatment because a portion of patients with cancer may be resistant to traditional therapies.
Nurses need to be aware of this potential intervention and management of adverse events in practice. Education would be required to manage adverse effects and side effects of this intervention.
Mishra, S.I., Scherer, R.W., Geigle, P.M., Berlanstein, D.R., Topaloglu, O., Gotay, C.C., & Snyder, C. (2012). Exercise interventions on health-related quality of life for cancer survivors. Cochrane Database of Systematic Reviews, 8, CD007566.
To conduct a meta-analysis of the effectiveness of exercise interventions on health-related quality of life (HRQoL) and domains (e.g., physical, psychological, economic, social, and spiritual well-being) of HRQoL among adult cancer survivors posttreatment.
Databases searched were Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, MEDLINE, EMBASE, CINAHL, PsycINFO, PEDro, LILACS, SIGLE, SPORTDiscus, OTSeeker, Sociological Abstracts, Web of Science, and Scopus.
Search keywords (selected from appendices) were exercise, quality of life, health-related quality of life, pain, and cancer.
Studies were included in the review if they
Studies were excluded if they reported patients with terminal cancer or in hospice care who were receiving active treatment for primary or recurrent cancer.
A total of 1,795 relevant references were retrieved. A total of 1,636 articles were excluded based on the title and abstract. After further review of the abstract, 82 were excluded because they did not meet the inclusion criteria. An additional 13 were excluded from qualitative synthesis because they were ongoing studies.
The review has clinical applicability for late effects and survivorship.
Exercise had a positive effect on change in HRQoL scores at 12 weeks and six months of evaluation, and it improved cancer-specific HRQoL in breast cancer concerns. The effect on HRQoL remained after exclusion of patients who were receiving active treatment. For cancer-specific HRQoL, there was significant improvement in exercise groups compared with controls for breast cancer concerns at baseline to 12 weeks and six months. There was a significant decrease in anxiety in the exercise group compared to controls at 12 weeks only (standardized mean difference [SMD] = -0.26; 95% confidence interval [CI] [-0.44, -0.07]) but not in breast cancer-only analysis. There was a high risk of bias in most of these studies, and when these were removed, the results were not significant. Significant differences were noted in body image at follow-up (12 weeks to six months and beyond) using the Rosenberg Self-Esteem Scale. Significant change scores were noted for cancers other than breast for improving depression scores (SMD = -0.46; 95% CI [-0.72, -0.19]). Significant improvements were noted in emotional well being (12 weeks) and fatigue (12 weeks and 6 months) (SMD = -0.42; 95% CI [-0.83, -0.02]). No effects after six months were seen for fatigue, and effects were not significant when studies involving patients during treatment were excluded. Improvement in pain using follow-up scores (12 weeks) was seen (SMD = -0.29; 95% CI [-0.55, -0.04]), but this was from a single trial. Positive effects were noted in sexuality scores at six months and sleep disturbance at 12 weeks (sleep SMD = -0.46; 95% CI [-0.72, -0.20]). Significant improvements were noted in change scores for social functioning (12 weeks and six months). No significant changes were noted in cognitive function, general health perspective, role function, and spirituality in exercise trials.
Exercise interventions showed beneficial effects on HRQoL and some HRQoL domains, including breast cancer concerns, body image, emotional well being, sexuality, sleep disturbances, social functioning, anxiety, fatigue, and pain at various follow-up time points.
Findings supported the general benefit of exercise for patients with cancer; however, there is further need for research to verify the positive effects of exercise on symptoms of cancer in various patient groups and at various phases of cancer care. These future research studies should determine how to produce larger effect sizes over time and delineate predictors of that effect, such as type of exercise, intensity of the program, timing, and type of cancer and treatment in order to maximize the effect on QoL. It will be important to note that certain questionnaires can affect the outcomes, and consistency would improve this body of research.
Mishra, S.I., Scherer, R.W., Snyder, C., Geigle, P., & Gotay, C. (2014). Are exercise programs effective for improving health-related quality of life among cancer survivors? A systematic review and meta-analysis. Oncology Nursing Forum, 41, E326–E342.
PURPOSE: To evaluate the effectiveness of exercise interventions on several domains of health-related quality of life
PHASE OF CARE: Late effects and survivorship
Studies included those with interventions such as yoga, tai chi, and qigong, as well as more traditional exercises. Moderate to vigorous exercise was associated with positive effects on quality of life (SMD = 0.29, 95% CI = 0, 0.58), but no effect was seen for mild to moderate level exercise. These findings did not differ by type of cancer. Anxiety was reduced in all studies by 12 weeks, but this was not observed at longer follow-up periods. At 12 weeks, more vigorous exercise showed no overall effect on anxiety with pooled data. However, a significant effect was seen with mild to moderate exercise (SMD = -0.26, 95% CI = -0.02,-0.51). For fatigue, there were significant positive effects at 12 weeks and between three and six months, but not at six months
The findings of this review show the benefits of various types of exercise on anxiety, fatigue, and quality of life among cancer survivors. Results varied by exercise intensity and at various time points in patient follow-up. This suggests that benefits exist mainly in the short-term up to six months.
Most studies showed a moderate to high risk of bias. All types of exercise were combined with various mind/body interventions, which would affect the results of the meta-analysis. It is not clear that these various types of interventions are truly equivalent types of interventions. The methods of measurement for the studies included were not provided, and differences in measurement would affect the meta-analysis. The search result volumes differed in two areas of this report. The differences reported by exercise intensity are confusing. It is not clear how more vigorous exercise improved quality of life while less vigorous exercise only affected anxiety.
Overall findings confirm other findings that exercise is beneficial for patients with cancer at various phases of care. This particular analysis was aimed at cancer survivors who completed initial treatment. It is of interest that the benefits of interventions appear to wane around the six-month timeframe. It is not clear if the interventions were done in a group setting for some time period or if social interaction could have influenced the findings that long-term effects were not generally seen if group exercise activity had ceased. Future research in this area should incorporate data to facilitate our understanding of the longevity of effects and mechanisms to maintain improvements long-term.