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Efficacy of dronabinol alone and in combination with ondansetron versus ondansetron alone for delayed chemotherapy-induced nausea and vomiting
Abstract
OBJECTIVE: To compare the efficacy and tolerability of dronabinol, ondansetron, or the combination for delayed chemotherapy-induced nausea and vomiting (CINV) in a 5-day, double-blind, placebo-controlled study. RESEARCH DESIGN AND METHODS: Patients receiving moderately to highly emetogenic chemotherapy received dexamethasone (20 mg PO), ondansetron (16 mg IV) and either placebo or dronabinol (2.5 mg) prechemotherapy on day 1. Patients randomized to active treatment (dronabinol and/or ondansetron) also received dronabinol (2.5 mg) after chemotherapy on day 1. On day 2, fixed doses of placebo, dronabinol (10 mg), ondansetron (16 mg), or combination therapy were administered. On days 3-5, patients received placebo, flexible doses of dronabinol (10-20 mg), ondansetron (8-16 mg), or dronabinol and ondansetron (10-20 mg dronabinol, 8-16 mg ondansetron). MAIN OUTCOME MEASURES: Total response (TR = nausea intensity <5 mm on visual analog scale, no vomiting/retching, no rescue antiemetic), nausea (occurrence and intensity) and vomiting/retching episodes. RESULTS: Sixty-four patients were randomized; 61 analyzed for efficacy. TR was similar with dronabinol (54%), ondansetron (58%), and combination therapy (47%) versus placebo (20%). Nausea absence was significantly greater in active treatment groups (dronabinol, 71%; ondansetron, 64%; combination therapy, 53%) versus placebo (15%; p < 0.05 vs. placebo for all). Nausea intensity and vomiting/retching were lowest in patients treated with dronabinol. Active treatments were well tolerated. The low number of patients due to slow enrollment limits the interpretation of these data. CONCLUSIONS: Dronabinol or ondansetron was similarly effective for the treatment of CINV. Combination therapy with dronabinol and ondansetron was not more effective than either agent alone. Active treatments were well tolerated.
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“Only one RCT has compared cannabinoids to a guideline medication (ondansetron) for CINV prevention [95] and none compared them to new generation drugs (5-HT3- or NK1 antagonists or neuroleptics) [94].”
From Cannabis, cannabinoids and health: a review of evidence on risks and medical benefits (2025) · cites this paper as [95]
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Metadata
- Authors
- Meiri, E., Jhangiani, H., Vredenburgh, J. J., Barbato, L. M., Carter, F. J., Yang, H.-M., & Baranowski, V.
- Affiliations
- Bethesda Hospital East (US)
- Compassionate Cancer Care (US)
- Duke Medical Center (US)
- Solvay (United States) (US)
- Corresponding author
- Meiri, Eyal
- Venue
- Current Medical Research and Opinion
- Publisher
- Informa Healthcare
- Published
- 2007-02-01
- Volume
- 23
- Issue
- 3
- Pages
- 533-543
- ISSN
- 0300-7995 (ISSN-L)
- 1473-4877
- OpenAlex
- W2053215778
- Cited by
- 214
- References
- 24
- Citations by year
- 2025: 10 · 2024: 17 · 2023: 9 · 2022: 21 · 2021: 16 · 2020: 15 · 2019: 18 · 2018: 18 · 2017: 12 · 2016: 15 · 2015: 13 · 2014: 7 · 2013: 8 · 2012: 8
- FWCI
- 7.97
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Current Medical Research and Opinion (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Surgery › Nausea and vomiting management
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Pregnancy and Medication Impact
- Health Sciences › Medicine › Oncology › Cancer survivorship and care
- Keywords
- dronabinol, ondansetron, combination antiemetic therapy, cannabinoids, antiemetic efficacy, tolerability, dexamethasone
- MeSH terms
- Adolescent, Adult, Analysis of Variance, Antineoplastic Combined Chemotherapy Protocols, Dose-Response Relationship, Drug, Double-Blind Method, Drug Administration Schedule, Drug Therapy, Combination, Female, Follow-Up Studies, Humans, Male, Middle Aged, Nausea, Neoplasms, Probability, Reference Values, Dronabinol, Vomiting, Treatment Outcome, Ondansetron, Risk Assessment
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