Oral THC:CBD cannabis extract for refractory chemotherapy-induced nausea and vomiting: a randomised, placebo-controlled, phase II crossover trial
Open accessAbstract
Background This multicentre, randomised, double-blinded, placebo-controlled, phase II/III trial aimed to evaluate an oral THC:CBD (tetrahydrocannabinol:cannabidiol) cannabis extract for prevention of refractory chemotherapy-induced nausea and vomiting (CINV). Here we report the phase II component results. Patients and methods Eligible patients experienced CINV during moderate-to-high emetogenic intravenous chemotherapy despite guideline-consistent antiemetic prophylaxis. Study treatment consisted of one cycle of 1-4 self-titrated capsules of oral THC 2.5 mg/CBD 2.5 mg (TN-TC11M) three times daily, from days -1 to 5, and 1 cycle of matching placebo in a crossover design, then blinded patient preference for a third cycle. The primary end point was the proportion of participants with complete response during 0-120 h from chemotherapy. A total of 80 participants provided 80% power to detect a 20% absolute improvement with a two-sided P value of 0.1. Results A total of 81 participants were randomised; 72 completing two cycles were included in the efficacy analyses and 78 not withdrawing consent were included in safety analyses. Median age was 55 years (range 29-80 years); 78% were female. Complete response was improved with THC:CBD from 14% to 25% (relative risk 1.77, 90% confidence interval 1.12-2.79, P = 0.041), with similar effects on absence of emesis, use of rescue medications, absence of significant nausea, and summary scores for the Functional Living Index-Emesis (FLIE). Thirty-one percent experienced moderate or severe cannabinoid-related adverse events such as sedation, dizziness, or disorientation, but 83% of participants preferred cannabis to placebo. No serious adverse events were attributed to THC:CBD. Conclusion The addition of oral THC:CBD to standard antiemetics was associated with less nausea and vomiting but additional side-effects. Most participants preferred THC:CBD to placebo. Based on these promising results, we plan to recruit an additional 170 participants to complete accrual for the definitive, phase III, parallel group analysis. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12616001036404; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370473&isReview=true.
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Extracts containing THC and CBD at a ratio 1:1 reduced nausea and vomiting in cancer patients receiving chemotherapy when administered thrice per day as add-on therapy.
“recent studies have continued to evaluate the effects of cannabis extracts rich in both THC and CBD for this purpose, and showed that extracts containing THC and CBD at a ratio 1:1 reduced the nausea and vomiting in cancer patients receiving chemotherapy when administered thrice per day as add-on therapy [33].”
From Supercritical Carbon Dioxide Technology for Recovering Valuable Phytochemicals from Cannabis sativa L. and Valorization of Its Biomass for Food Applications (2023) · cites this paper as [33]
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“In the last cycle, most of the participants opted for the same treatment arm, which may have had an impact on the results; therefore, domain 4 was considered to be a high risk of bias 25 .”
BackgroundInfluentialEndocannabinoid System and the Otolaryngologist.
Tapasak, B., Edelmayer, L., & Seidman, M. (2022) · Otolaryngologic clinics of North America · doi:10.1016/j.otc.2022.06.012 · Cited by 5 · see citing works
Weight loss outcomes are not compromised in bariatric patients using cannabis
Huang, E. Y., Broderick, R., Li, J. Z., Serra, J. L., Ahuja, P., Wu, S., Genz, M., Grunvald, E., Kunkel, D., Sandler, B., et al. (2022) · Surgical Endoscopy · doi:10.1007/s00464-022-09453-x · Cited by 5
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“However, chemotherapy-induced nausea and vomiting (CINV) is the most common adverse event (5).”
BackgroundNayak, M., Chai, P., Tung, S., Revette, A., & Braun, I. M. (2025) · Clinical Therapeutics · doi:10.1016/j.clinthera.2025.11.004 · Cited by 4
Kasvis, P., Canac‐Marquis, M., Aprikian, S., Vigano, M., & Vigano, A. A. L. (2022) · Supportive Care in Cancer · doi:10.1007/s00520-022-07193-1 · Cited by 6 · see citing works
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Esmaeli, M., & Dehabadi, M. D. (2025) · Medical Oncology · doi:10.1007/s12032-025-02790-6 · Cited by 3
“Across three clinical trials involving a total of 148 patients with colorectal or upper GI malignancies, CBD was consistently associated with improvements in appetite, reduction in chemotherapy-induced nausea and vomiting (CINV), and enhanced quality of life [68–71].”
Bellas, O. M., Cao, K., Bowen, J. M., Smid, S. D., Shakib, S., Crawford, G. B., Zannettino, A. C. W., Yeung, D. T. O., Kichenadasse, G., Boublik, J., et al. (2025) · BMJ Open · doi:10.1136/bmjopen-2024-089336 · Cited by 4 · see citing works
Medical cannabis use in oncology and associated outcomes: A scoping review
Valente, A. C., Lopes, L. P. N., & Matheus, M. E. (2024) · Journal of Oncology Pharmacy Practice · doi:10.1177/10781552241239006 · Cited by 7 · see citing works
“4,9 Importantly, the safety pro fi le of cannabis stands out when compared to other medications.”
BackgroundVieira, C., Bergantim, R., Madureira, E., Barroso, J. C. M., Labareda, M., Parreira, S. T., Castro, A., Macedo, A., & Custódio, S. (2023) · Porto Biomedical Journal · doi:10.1097/j.pbj.0000000000000234 · Cited by 3 · see citing works
“38-40 However, it is essential to consider the potential AEs arising from their use, namely dysphoria, euphoria, and sedation (two clinical studies 38,39 and one meta-analysis 40 ).”
BackgroundRomeyke, T., & Westfal, R. (2022) · Medical Cannabis and Cannabinoids · doi:10.1159/000527521 · Cited by 3 · see citing works
Sant’Ana, R. R. A., Soldi, C., Amboni, R. D. D. M. C., & Fritzen‐Freire, C. B. (2026) · Critical Reviews in Food Science and Nutrition · doi:10.1080/10408398.2026.2629026 · Cited by 1 · see citing works
“The molecule has been associated with medical applications, exhibiting analgesic effects, appetite stimulation, nausea prevention, among others, and can be used to alleviate symptoms in chemotherapy patients (Grimison et al. 2020; Ramírez and Viveros 2021).”
Demographics, methods of use, and perceived benefits among patients with cancer who use cannabis
Behl, D., D’Andre, S. D., Hankins, A. I., Tiet, K., Portugal, J., & Parise, C. A. (2026) · Supportive Care in Cancer · doi:10.1007/s00520-026-10452-0 · Cited by 3 · see citing works
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“Self-reported use of THC-domi-nant products was most prevalent among participants accessing both prescribed and illicit products (‘dual’) (52.9% [9/17), whereas THC-dominant and CBD/THC equivalent products were equally common among those using prescribed MC products (35.7% [19/56]).”
InfluentialSelf-citationGallow, S., Ross, A., Mkhize, B., Pillay, P., & Tonkin, K. (2025) · Next Research · doi:10.1016/j.nexres.2025.100506 · Cited by 2 · see citing works
Stefanidis, K., Schiemer, C., Mieran, T., Hill, A., Horswill, M., & Summers, M. (2025) · Drug and Alcohol Review · doi:10.1111/dar.14060 · Cited by 2 · see citing works
Long-term stability and bactericidal properties of galenic formulations of Cannabis sativa oils
Orallo, D. E., Fuentes, G., Benavidez, M. G., Suárez, P. A., Nutter, D., Fangio, M. F., & Ramírez, C. L. (2024) · Fitoterapia · doi:10.1016/j.fitote.2024.106128 · Cited by 3 · see citing works
Pearson, B. E., Walker, M., Tempero, J., Ong, K., & Lucas, P. (2024) · Cannabis · doi:10.26828/cannabis/2024/000239 · Cited by 3 · see citing works
Should gastroenterologists prescribe cannabis? The highs, the lows and the unknowns
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Cannabis use in gynecologic cancer patients in a Canadian cancer center
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Rock, E. M., Limebeer, C. L., Smoum, R., Mechoulam, R., & Parker, L. A. (2022) · Cannabis and Cannabinoid Research · doi:10.1089/can.2022.0158 · Cited by 5 · see citing works
“12 Adverse events such as sedation, dizziness, and disorientation were reported, but most patients (85”
Esmaeli, M., & Dehabadi, M. D. (2025) · Cancer Cell International · doi:10.1186/s12935-025-04010-7 · Cited by 1 · see citing works
Medical marijuana in the treatment of cancer-associated symptoms
Micha, J. P., Rettenmaier, M. A., Bohart, R. D., & Goldstein, B. H. (2024) · Journal of Oncology Pharmacy Practice · doi:10.1177/10781552241262963 · Cited by 1 · see citing works
Tam, A., Novak, J., Ladbury, C., Abuali, T., Loscalzo, M., Sun, V., & Amini, A. (2024) · International Journal of Radiation Oncology, Biology, Physics · doi:10.1016/j.ijrobp.2024.02.045 · Cited by 1
Cannabinoide Arzneimittel bei Krebspatient*innen
Herdegen, T. (2023) · Zeitschrift für Komplementärmedizin · doi:10.1055/a-2188-1270 · Cited by 1
Nayak, M., Chai, P., Tung, S., Tulsky, J. A., Hammer, M. J., Andrade, N., & Braun, I. M. (2023) · Cancer Medicine · doi:10.1002/cam4.6634 · Cited by 1
[Chemotherapy-induced nausea and vomiting].
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Approach the prevention of chemotherapy-induced nausea and vomiting in older patients with care
Kang, C. (2022) · Drugs & Therapy Perspectives · doi:10.1007/s40267-022-00952-4 · Cited by 1 · see citing works
Hu, M., Lanhui, Y., Li, L., Yong-hong, H., Wang, Y., Zhang, L., & Wu, H. (2022) · Medicine · doi:10.1097/md.0000000000030088 · Cited by 1 · see citing works
“On the 1st to 6th day of chemotherapy, the R-INVR scale[12] and Functional Living Index Emesis (FLIE) questionnaire[13] were used to evaluate symptoms and quality of life, respectively.”
BackgroundMethodMetabolic effects of medical cannabis treatment
Habib, G., & Aamar, S. (2022) · Journal of Investigative Medicine · doi:10.1136/jim-2021-002059 · Cited by 1
O sistema endocanabinoide e as dores orofaciais: atualidades e perspectivas
Tanganeli, J. P. C., Haddad, D. S., Rode, S. D. M., Tambeli, C. H., & Grossmann, E. (2023) · Brazilian Journal Of Pain · doi:10.5935/2595-0118.20230038-pt · Cited by 1
“…coadjuvante em pacientes oncológicos, incluindo na cabeça e no pescoço, logo no início do tratamento, pelo seu efeito analgésico, poupador de opioides e antiemético 37 , o que contribui para a redução dos efeitos adversos induzidos pela quimioterapia e para a melhora da qualida-de de vida 38 .”
BackgroundCannabinoids in oncology: pharmacology, clinical applications, and translational perspectives
Safran, E., Safran, H. P., & Kim, S. (2026) · Frontiers in Pharmacology · doi:10.3389/fphar.2026.1969657
“…be individualized (Braun et al., 2024; Herrstedt et al., 2024; National Comprehensive Cancer Network, 2026; Fallon et al., 2017; Johnson et al., 2010; Jatoi et al., 2002; Strasser et al., 2006; Duran et al., 2010; Grimison et al., 2020; Grimison et al., 2024; National Cancer Institute, 2026).”
Shalata, W., & Soklakova, A. (2026) · Neurologic Clinics · doi:10.1016/j.ncl.2026.08.014
- Authors
- Grimison, P., Mersiades, A., Kirby, A., Lintzeris, N., Morton, R., Haber, P., Olver, I., Walsh, A., McGregor, I., Cheung, Y., Tognela, A., Hahn, C., Briscoe, K., Aghmesheh, M., Fox, P., Abdi, E., Clarke, S., Della-Fiorentina, S., Shannon, J., Gedye, C., Begbie, S., Simes, J., & Stockler, M.
- Affiliations
- Chris O’Brien Lifehouse (AU)
- National Health and Medical Research Council (AU)
- South Eastern Sydney Local Health District (AU)
- The University of Sydney (AU)
- The University of Adelaide (AU)
- Camden and Campbelltown Hospitals (AU)
- Wollongong Hospital (AU)
- Northern Cancer Institute (AU)
- Nepean Hospital (AU)
- Calvary Mater Newcastle Hospital (AU)
- Corresponding author
- Grimison, P.
- ORCID
- Venue
- Annals of Oncology
- Publisher
- Elsevier BV
- Published
- 2020-11
- Volume
- 31
- Issue
- 11
- Pages
- 1553-1560
- ISSN
- 0923-7534 (ISSN-L)
- OpenAlex
- W3048881461
- Cited by
- 162
- References
- 0
- Citations by year
- 2026: 16 · 2025: 26 · 2024: 42 · 2023: 26 · 2022: 40 · 2021: 11 · 2020: 1
- FWCI
- 17.86
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- Annals of Oncology (publishedVersion)
- PubMed (publishedVersion)
- Griffith Research Online (submittedVersion, other-oa)
- Funders
- NSW Ministry of Health
- Topics
- Health Sciences › Medicine › Surgery › Nausea and vomiting management
- Health Sciences › Medicine › Pharmacology › Cannabis and Cannabinoid Research
- Health Sciences › Medicine › Oncology › Cancer survivorship and care
- Keywords
- tetrahydrocannabinol, cannabidiol, chemotherapy-induced nausea and vomiting, antiemetic prophylaxis, emesis prevention, patient preferences, Functional Living Index-Emesis, emetogenic chemotherapy, crossover trial
- MeSH terms
- Adult, Aged, Aged, 80 and over, Antiemetics, Antineoplastic Agents, Australia, Cannabidiol, Cannabis, Double-Blind Method, Drug Combinations, Female, Humans, Male, Middle Aged, Nausea, Plant Extracts, Dronabinol, Vomiting, Cross-Over Studies
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