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The Lancet. Oncology Feb 2020Olanzapine 10 mg added to standard antiemetic therapy including aprepitant, palonosetron, and dexamethasone has been recommended for the prevention of... (Randomized Controlled Trial)
Randomized Controlled Trial
Olanzapine 5 mg plus standard antiemetic therapy for the prevention of chemotherapy-induced nausea and vomiting (J-FORCE): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial.
BACKGROUND
Olanzapine 10 mg added to standard antiemetic therapy including aprepitant, palonosetron, and dexamethasone has been recommended for the prevention of chemotherapy-induced nausea and vomiting. Guidelines suggest that a dose reduction to 5 mg should be considered to prevent sedation. In several phase 2 studies, olanzapine 5 mg has shown equivalent activity to olanzapine 10 mg and a favourable safety profile in relation to somnolence. We evaluated the efficacy of olanzapine 5 mg combined with standard antiemetic therapy for the prevention of chemotherapy-induced nausea and vomiting caused by cisplatin-based chemotherapy.
METHODS
This was a randomised, double-blind, placebo-controlled, phase 3 study to evaluate the efficacy of olanzapine 5 mg with triplet-combination antiemetic therapy done in 26 hospitals in Japan. Key inclusion criteria were patients with a malignant tumour (excluding those with a haemopoietic malignancy) who were scheduled to be treated with cisplatin (≥50 mg/m) for the first time, age between 20 and 75 years, and with Eastern Cooperative Oncology Group performance status of 0-2. Eligible patients were randomly assigned (1:1) to receive either oral olanzapine 5 mg or placebo once daily on days 1-4 combined with aprepitant, palonosetron, and dexamethasone (dosage based on the standard antiemetic therapy against highly emetogenic chemotherapy). Patients were randomly assigned to interventions by use of a web entry system and the minimisation method with a random component, with sex, dose of cisplatin, and age as factors of allocation adjustment. Patients, medical staff, investigators, and individuals handling data were all masked to treatment assignment. The primary endpoint was the proportion of patients who achieved a complete response, defined as absence of vomiting and no use of rescue medications in the delayed phase (24-120 h). All randomly assigned patients who satisfied eligibility criteria received a dose of cisplatin 50 mg/m or more, and at least one study treatment, were included in efficacy analysis. All patients who received any treatment in this study were assessed for safety. This study is registered at UMIN Clinical Trials Registry, number UMIN000024676.
FINDINGS
Between Feb 9, 2017, and July 13, 2018, 710 patients were enrolled; 356 were randomly assigned to receive olanzapine and 354 were assigned to receive placebo. All eligible patients were observed 120 h after cisplatin initiation. One patient in the olanzapine group and three in the placebo group did not receive treatment and were excluded from all analyses. One patient in the olanzapine group discontinued treatment on day 1 and was excluded from the efficacy analysis. In the delayed phase, the proportion of patients who achieved a complete response was 280 (79% [95% CI 75-83] of 354 patients in the olanzapine group and 231 (66% [61-71] of 351 patients in the placebo group (p<0·0001). One patient had grade 3 constipation and one patient had grade 3 somnolence related to treatment in the olanzapine group.
INTERPRETATION
Olanzapine 5 mg combined with aprepitant, palonosetron, and dexamethasone could be a new standard antiemetic therapy for patients undergoing cisplatin-based chemotherapy.
FUNDING
Japan Agency for Medical Research and Development.
Topics: Adult; Aged; Antiemetics; Antineoplastic Combined Chemotherapy Protocols; Aprepitant; Cisplatin; Dexamethasone; Double-Blind Method; Female; Humans; Japan; Male; Middle Aged; Olanzapine; Palonosetron; Postoperative Nausea and Vomiting; Time Factors; Treatment Outcome; Young Adult
PubMed: 31838011
DOI: 10.1016/S1470-2045(19)30678-3 -
Journal of Pain & Palliative Care... Jun 2021Nausea and vomiting are common within the palliative care population. Antiemetic agents may help control symptoms, but may also place patients at risk for QTc... (Review)
Review
Nausea and vomiting are common within the palliative care population. Antiemetic agents may help control symptoms, but may also place patients at risk for QTc prolongation. This article reviews pharmacotherapy agents including anticholinergics, antihistamines, antidopaminergics, 5-HT3 receptor antagonists, dronabinol, and medical marijuana and their associated risk of QTc prolongation. A clinical treatment pathway is provided to help guide clinicians in choosing the most appropriate antiemetic based upon patient specific factors for QTc prolongation.
Topics: Antiemetics; Antineoplastic Agents; Humans; Long QT Syndrome; Nausea; Palliative Care; Vomiting
PubMed: 33974499
DOI: 10.1080/15360288.2021.1900491 -
Health Technology Assessment... Oct 2016Nausea and vomiting in pregnancy (NVP) affects up to 85% of all women during pregnancy, but for the majority self-management suffices. For the remainder, symptoms are... (Review)
Review
BACKGROUND
Nausea and vomiting in pregnancy (NVP) affects up to 85% of all women during pregnancy, but for the majority self-management suffices. For the remainder, symptoms are more severe and the most severe form of NVP - hyperemesis gravidarum (HG) - affects 0.3-1.0% of pregnant women. There is no widely accepted point at which NVP becomes HG.
OBJECTIVES
This study aimed to determine the relative clinical effectiveness and cost-effectiveness of treatments for NVP and HG.
DATA SOURCES
MEDLINE, EMBASE, Cumulative Index to Nursing and Allied Health Literature, Cochrane Central Register of Controlled Trials, PsycINFO, Commonwealth Agricultural Bureaux (CAB) Abstracts, Latin American and Caribbean Health Sciences Literature, Allied and Complementary Medicine Database, British Nursing Index, Science Citation Index, Social Sciences Citation Index, Scopus, Conference Proceedings Index, NHS Economic Evaluation Database, Health Economic Evaluations Database, China National Knowledge Infrastructure, Cochrane Database of Systematic Reviews and Database of Abstracts of Reviews of Effects were searched from inception to September 2014. References from studies and literature reviews identified were also examined. was hand-searched, as were websites of relevant organisations. Costs came from NHS sources.
REVIEW METHODS
A systematic review of randomised and non-randomised controlled trials (RCTs) for effectiveness, and population-based case series for adverse events and fetal outcomes. Treatments: vitamins B6 and B12, ginger, acupressure/acupuncture, hypnotherapy, antiemetics, dopamine antagonists, 5-hydroxytryptamine receptor antagonists, intravenous (i.v.) fluids, corticosteroids, enteral and parenteral feeding or other novel treatment. Two reviewers extracted data and quality assessed studies. Results were narratively synthesised; planned meta-analysis was not possible due to heterogeneity and incomplete reporting. A simple economic evaluation considered the implied values of treatments.
RESULTS
Seventy-three studies (75 reports) met the inclusion criteria. For RCTs, 33 and 11 studies had a low and high risk of bias respectively. For the remainder ( = 20) it was unclear. The non-randomised studies ( = 9) were low quality. There were 33 separate comparators. The most common were acupressure versus placebo ( = 12); steroid versus usual treatment ( = 7); ginger versus placebo ( = 6); ginger versus vitamin B6 ( = 6); and vitamin B6 versus placebo ( = 4). There was evidence that ginger, antihistamines, metoclopramide (mild disease) and vitamin B6 (mild to severe disease) are better than placebo. Diclectin [Duchesnay Inc.; doxylamine succinate (10 mg) plus pyridoxine hydrochloride (10 mg) slow release tablet] is more effective than placebo and ondansetron is more effective at reducing nausea than pyridoxine plus doxylamine. Diclectin before symptoms of NVP begin for women at high risk of severe NVP recurrence reduces risk of moderate/severe NVP compared with taking Diclectin once symptoms begin. Promethazine is as, and ondansetron is more, effective than metoclopramide for severe NVP/HG. I.v. fluids help correct dehydration and improve symptoms. Dextrose saline may be more effective at reducing nausea than normal saline. Transdermal clonidine patches may be effective for severe HG. Enteral feeding is effective but extreme method treatment for very severe symptoms. Day case management for moderate/severe symptoms is feasible, acceptable and as effective as inpatient care. For all other interventions and comparisons, evidence is unclear. The economic analysis was limited by lack of effectiveness data, but comparison of costs between treatments highlights the implications of different choices.
LIMITATIONS
The main limitations were the quantity and quality of the data available.
CONCLUSION
There was evidence of some improvement in symptoms for some treatments, but these data may not be transferable across disease severities. Methodologically sound and larger trials of the main therapies considered within the UK NHS are needed.
STUDY REGISTRATION
This study is registered as PROSPERO CRD42013006642.
FUNDING
The National Institute for Health Research Health Technology Assessment programme.
Topics: Antiemetics; Clinical Trials as Topic; Complementary Therapies; Cost-Benefit Analysis; Female; Fluid Therapy; Humans; Hyperemesis Gravidarum; Nausea; Pregnancy
PubMed: 27731292
DOI: 10.3310/hta20740 -
Frontiers in Public Health 2023Complementary and alternative medicine (CAM) therapies are widely used for nausea and vomiting during pregnancy (NVP) due to the limitations of conventional medicine.... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Complementary and alternative medicine (CAM) therapies are widely used for nausea and vomiting during pregnancy (NVP) due to the limitations of conventional medicine. However, their efficacy and safety remain controversial. Therefore, this meta-analysis was performed to assess the improvement of CAM therapy on NVP.
METHODS
Randomized controlled trials (RCTs) were searched for where the trial group was CAM and the control group was a conventional medicine or a placebo for NVP. This was done 8 databases, including PubMed, EMBASE, the Cochrane Library, Web of Science, China National Knowledge Infrastructure, Wanfang, SinoMed, and VIP, from inception to October 25, 2022. The Grades of Recommendation, Assessment, Development and Evaluation (GRADE) was used to assess the quality of evidence. The Stata 15.0 software was used to perform the meta-analysis.
RESULTS
Thirty-three RCTs were included in this study. The acupuncture treatment was superior to conventional medicine at the effective rate [RR = 1.71, 95% CI (1.02, 2.86), = 0.042; Low-quality evidence]. Ginger had more significant effects than conventional medicine at the Rhodes index [WMD = -0.52, 95% CI (-0.79, -0.24), ≤ 0.001; Moderate-quality evidence] and it had the same effect as drugs to relieve vomiting [SMD = 0.30, 95% CI (-0.12, 0.73), = 0.160; Low-quality evidence]. Compared with placebo, ginger had a higher effective rate [RR = 1.68, 95% CI (1.09, 2.57), = 0.018; Low-quality evidence], and lower Visual analog scale (VAS) of Nausea [WMD = -1.21, 95% CI (-2.34, -0.08), = 0.036; Low-quality evidence]. Ginger had the same antiemetic effect as placebo [WMD = 0.05, 95% CI (-0.23, 0.32), = 0.743; Low-quality evidence]. Acupressure was superior to conventional medicine at the reduction of antiemetic drugs [SMD = -0.44, 95% CI (-0.77, -0.11), = 0.008; Low-quality evidence], and at the effective rate [RR = 1.55, 95% CI (1.30, 1.86), ≤ 0.001; Low-quality evidence]. Acupressure had the same effect as placebo at the effective rate [RR = 1.25, 95% CI (0.94, 1.65), = 0.124; Low-quality evidence]. Overall, CAM therapy was safer than conventional medicine or a placebo.
CONCLUSION
The results showed that CAM therapies were able to alleviate NVP. However, due to the low quality of existing RCTs, more RCTs with large sample sizes are needed to validate this conclusion in the future.
Topics: Female; Pregnancy; Humans; Vomiting; Complementary Therapies; Antiemetics; Nausea; Acupuncture Therapy; Randomized Controlled Trials as Topic
PubMed: 36969661
DOI: 10.3389/fpubh.2023.1108756 -
Supportive Care in Cancer : Official... Dec 2021Nausea and vomiting are a common clinical symptom in the advanced cancer patient. Pharmacologic management is important. Evidence for drug choices and guidelines are...
BACKGROUND
Nausea and vomiting are a common clinical symptom in the advanced cancer patient. Pharmacologic management is important. Evidence for drug choices and guidelines are needed to help clinicians manage nausea and vomiting in this population METHODS: Evidence from a systematic review published in 2010, initial MASCC guidelines developed from a systematic review of literature to 2015, and a new systematic review of randomized trials published between 2015 and February 2, 2021, was combined to establish a new guideline.
RESULTS
A search of the literature between 2015 and February 2, 2021, revealed 257 abstracts of which there was one systematic review and 4 randomized trials which were used to modify the guideline. The new guideline is as follows: First Line: Metoclopramide (II) multiple small RCTs including a placebo-controlled trial, haloperidol (II) multiple non-placebo-controlled RCTs, high consensus. Second line: Methotrimeprazine (II) 1 well-powered non-placebo-controlled RCT, olanzapine (II) 1 placebo-controlled pilot RCT, high consensus. Third line: Tropisetron (II) large unblinded lower quality non-placebo-controlled RCT, levosulpiride (II) 1 blinded non-placebo-controlled pilot RCT, high consensus.
DISCUSSION
Haloperidol, metoclopramide, methotrimeprazine, olanzapine tropisetron, and levosulpiride have been antiemetics used in randomized trials with antiemetic activity demonstrated. There are only three placebo-controlled randomized trials we could find in our literature review. Placebo responses varied significantly between two randomized trials. More randomized placebo-controlled trials with either metoclopramide or haloperidol rescue are needed to clarify antiemetic choices in advanced cancer.
CONCLUSION
First-line antiemetics for nausea and vomiting in advanced cancer are metoclopramide and haloperidol, and second-line medications are methotrimeprazine and olanzapine.
Topics: Antiemetics; Humans; Metoclopramide; Nausea; Neoplasms; Vomiting
PubMed: 34398289
DOI: 10.1007/s00520-021-06437-w -
Supportive Care in Cancer : Official... Jan 2019Chemotherapy-induced nausea and vomiting (CINV) is a common toxicity that may impair the quality of life of patients with a variety of early- and end-stage malignancies.... (Comparative Study)
Comparative Study Review
Chemotherapy-induced nausea and vomiting (CINV) is a common toxicity that may impair the quality of life of patients with a variety of early- and end-stage malignancies. In light of recent changes in the optimal management of CINV, we undertook this narrative review to compare the latest guidelines published by ASCO (2017), NCCN (2018), and MASCC/ESMO (2016). The processes undertaken by each organization to evaluate existing literature were also described. Although ASCO, NCCN, and MASCC/ESMO guidelines for the treatment and prevention of CINV share many fundamental similarities, literature surrounding low and minimal emetic risk regimens is lacking. Data regarding the use of complementary alternative medicine for CINV is particularly scarce and in need of further investigation.
Topics: Adult; Antiemetics; Antineoplastic Combined Chemotherapy Protocols; Humans; Nausea; Neoplasms; Practice Guidelines as Topic; Practice Patterns, Physicians'; Quality of Life; Societies, Medical; Vomiting
PubMed: 30284039
DOI: 10.1007/s00520-018-4464-y -
Supportive Care in Cancer : Official... Dec 2021Malignant bowel obstruction (MBO) is a frequent complication in patients with advanced cancer, particularly colon or gynecological malignancies. MASCC previously...
BACKGROUND
Malignant bowel obstruction (MBO) is a frequent complication in patients with advanced cancer, particularly colon or gynecological malignancies. MASCC previously published a guideline for symptom management of MBO in 2017. This is a 5-year update.
METHOD
A systematic search and review of relevant literature includes a review published in 2010 and 2017. The guideline update used the same literature search process as followed in 2015. The dates of the new search included 2015 up to February 2, 2021. The guidelines involved the pharmacologic management of nausea and vomiting in malignant bowel obstruction (MBO) only. Only randomized trials were included in the updated guideline as evidence. The evidence was reviewed by the panel and the MASCC criteria for establishing a guideline were followed using MASCC level of grading and category of evidence.
RESULTS
There was one systematic review and 3 randomized trials accepted as evidence from 257 abstracts. Octreotide is effective in reducing gastrointestinal secretions and colic and thereby reduces nausea and vomiting caused by MBO. Scopolamine butylbromide is inferior to octreotide in the doses used in the comparison study. Olanzapine or metoclopramide may be effective in reducing nausea and vomiting secondary to partial bowel obstructions. The panel suggests using either drug. Additional studies are needed to clarify benefits. Haloperidol has been used by convention as an antiemetic but has not been subjected to a randomized comparison. Ranitidine plus dexamethasone may be effective in reducing nausea and vomiting from MBO but cannot be recommended until there is a comparison with octreotide.
DISCUSSION
Octreotide remains the drug of choice in managing MBO. Ranitidine was used in one randomized trial in all participants and so its effectiveness as a single drug is not known until there is a randomized comparison with octreotide. Antiemetics such as metoclopramide and olanzapine may be effective, but we have very few randomized trials of antiemetics in MBO.
CONCLUSION
The panel recommends octreotide in non-operable MBO. Randomized trials are needed to clarify ranitidine and antiemetic choices.
Topics: Antiemetics; Humans; Intestinal Obstruction; Nausea; Neoplasms; Vomiting
PubMed: 34390398
DOI: 10.1007/s00520-021-06438-9 -
Anesthesia and Analgesia Nov 2022Although prophylactic antiemetics are commonly used perioperatively, an estimated 30% of surgical patients still suffer from postoperative nausea and vomiting (PONV)....
Although prophylactic antiemetics are commonly used perioperatively, an estimated 30% of surgical patients still suffer from postoperative nausea and vomiting (PONV). Very few prospective trials have studied rescue treatment of PONV after failure of prophylaxis, providing limited evidence to support clinical management. In patients who have failed PONV prophylaxis, administering a rescue antiemetic from the same drug class has been reported to be ineffective. For many antiemetics currently used in PONV rescue, significant uncertainty remains around the effective dose range, speed of onset, duration of effect, safety, and overall risk-benefit ratio. As prompt, effective PONV rescue after failure of prophylaxis is important to optimize postoperative recovery and resource utilization, we conduct this systematic review to summarize the current evidence available on the topic.
Topics: Humans; Postoperative Nausea and Vomiting; Antiemetics; Prospective Studies
PubMed: 36048730
DOI: 10.1213/ANE.0000000000006126 -
British Journal of Hospital Medicine... May 2020Nausea and vomiting are common symptoms in the hospital setting, with numerous causes. Common precipitants leading to or complicating inpatient hospital admissions... (Review)
Review
Nausea and vomiting are common symptoms in the hospital setting, with numerous causes. Common precipitants leading to or complicating inpatient hospital admissions include nausea and vomiting secondary to drugs, gastrointestinal disturbances, metabolic aberrancies, and vestibular pathologies. Appropriate selection and prescribing of antiemetic drugs is therefore important for healthcare professionals. There are numerous antiemetics available to physicians, ranging from muscarinic, dopaminergic and serotoninergic drugs, each acting on a different part of the nausea-vomiting cascade. This review describes the main pathophysiological processes involved in the development of symptomatic nausea and vomiting, and gives an overview of how common antiemetic drugs function to alleviate symptoms, alongside cautions and contraindications in their usage.
Topics: Antiemetics; Humans; Nausea; Vomiting
PubMed: 32468935
DOI: 10.12968/hmed.2020.0050 -
Seminars in Oncology Nursing Feb 2022To review recent updated antiemetic guidelines from national cancer organizations and its impact on chemotherapy-induced nausea and vomiting (CINV) in the prevention and... (Review)
Review
OBJECTIVE
To review recent updated antiemetic guidelines from national cancer organizations and its impact on chemotherapy-induced nausea and vomiting (CINV) in the prevention and delayed phase of therapy. This article will also describe assessment and nursing strategies for individualized care and timely side effect management.
DATA SOURCES
Data sources include peer-reviewed articles sourced in electronic databases.
CONCLUSION
CINV is a persistent problem for a large percentage of patients undergoing chemotherapy treatment despite advances in antiemetic therapy and increased use of targeted therapies. CINV management should be based on patient-focused assessment and adherence to national antiemetic guidelines. Ongoing assessment and follow-up are critical to ensure optimum management of side effects to optimized quality of life.
IMPLICATIONS FOR NURSING PRACTICE
Awareness of national antiemetic guidelines is important in caring for patients undergoing chemotherapy. CINV can have a significant impact on patients, causing physical effects, treatment delays, and diminished quality of life. Oncology nurses play a key role in assessment of patient-related risk factors, education of patients and caregivers regarding pain medications, side effects, and oral adherence and continued follow-up for early recognition and intervention for uncontrolled CINV.
Topics: Antiemetics; Antineoplastic Agents; Humans; Nausea; Neoplasms; Quality of Life; Vomiting
PubMed: 35219568
DOI: 10.1016/j.soncn.2022.151249