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Cannabis extract for secondary prevention of chemotherapy-induced nausea and vomiting: Results of a phase II/III, placebo-controlled, randomised trial.

Abstract Poster

Authors

null

Antony Mersiades

NHMRC Clinical Trials Centre, The University of Sydney; Northern Beaches Hospital,, Sydney, NSW, Australia

Antony Mersiades , Adrienne Kirby , Martin R. Stockler , Annette Tognela , Ian N. Olver , Rachael L. Morton , Paul Haber , Anna Walsh , Yvonne Lee , Ehtesham A. Abdi , Stephen Della-Fiorentina , Morteza Aghmesheh , Peter Fox , Karen P. Briscoe , Jasotha Sanmugarajah , Gavin M. Marx , Ganessan Kichenadasse , Helen Wheeler , John Simes , Peter S. Grimison

Organizations

NHMRC Clinical Trials Centre, The University of Sydney; Northern Beaches Hospital,, Sydney, NSW, Australia, NHMRC Clinical Trials Centre, The University of Sydney, Sydney, Australia, NHMRC Clinical Trials Centre, The University of Sydney, Camperdown, NSW, Australia, Campbelltown Hospital, Campbelltown, Australia, University of Adelaide, Adelaide, SA, Australia, NHMRC Clinical Trials Centre, The University of Sydney, Sydney, NSW, Australia, Sydney Medical School, University of Sydney, Camperdown, Australia, The Tweed Hospital, Griffith University, Southern Cross University, Tweed Heads, Gold Coast, Australia, Southern Highlands Cancer Centre,, Bowral, NSW, Australia, Illawarra Cancer Care Centre, Wollongong Hospital, Wollongong, NSW, Australia, Orange Health Service, Orange, NSW, Australia, Coffs Harbour Health Campus, Coffs Harbour, NSW, Australia, Gold Coast University Hospital, School of Medicine, Griffith University, Southport, QLD, Australia, Sydney Adventist Hospital, Sydney, Australia, Flinders Medical Centre, Bedford Park, South Australia, Australia, Royal North Shore Hospital, Sydney, NSW, Australia, Chris O'Brien Lifehouse, Sydney, NSW, Australia

Research Funding

Other Government Agency
NSW Health

Background: The aim of this multi-centre, randomised, placebo-controlled, phase II/III trial was to determine the efficacy of adding an oral THC/CBD (tetrahydrocannabinol/cannabidiol) cannabis extract in adults who experience CINV during moderate and highly emetogenic intravenous chemotherapy regimens despite guideline-consistent anti-emetic prophylaxis. The phase II crossover component has been published (Grimison et al, AnnOnc 2020). Here we report the definitive results from the combined phase II/III components with a planned sample size of 250 patients. Methods: For the definitive phase III component, participants were randomised 1:1 to receive, oral THC 2.5mg/CBD 2.5mg (Tilray TN-TC11M) capsules TDS days -1 to 5, or placebo (in addition to guideline-consistent anti-emetics including rescue medications) for cycles A, B and C. Primary endpoint was the difference in gaining a ‘complete response’ (no emesis and no use of rescue medications) during 0-120 hours from chemotherapy for cycle A. Results: Complete response was achieved in 24% and 8% with THC/CBD and placebo, respectively (absolute difference 16%, P-value 0.01). The study closed early due to slow accrual without knowledge of study outcomes, with a total of 147 patients recruited 2016-22 (pilot n=78, definitive n=69). Median age was 56 years (range 25 to 80), 78% were females, 39% reported historic cannabis use, 65% were treated with curative intent. Most common regimens were doxorubicin/cyclophosphamide (AC, 31%), and fluorouracil/oxaliplatin (FOLFOX, 17%), 97% received corticosteroid & 5-HT3 antagonist, 80% received NK-1 antagonist, 10% received olanzapine. Efficacy and safety are shown in the table. No SAEs were attributed to THC/CBD. Conclusions: Oral THC/CBD was associated with a significant increase in the proportion of patients achieving a complete response in chemotherapy-induced nausea and vomiting and was well tolerated, representing an effective new treatment in the management of this condition. Future analyses will report quality of life and cost-effectiveness. Funding from NSW Government Dept of Health. Drug supply by Tilray. Clinical trial information: ACTRN12616001036404.

Efficacy and cannabinoid-related adverse events.

OutcomeTHC/CBD
%		Placebo
%		Difference
% (95% CI)		P-value
Complete response*24816 (4, 28)0.01
No vomiting705812 (-4, 27)0.14
No use of rescue medications281019 (6, 31)0.01
No significant nausea (score <2)20713 (2, 24)0.03
Cannabinoid-related adverse eventTHC/CBD any gradePlacebo any gradeTHC/CBD Moderate/SeverePlacebo Moderate/Severe
Sedation
5424187
Dizziness4014100
Disorientation17530
Anxiety6831

* Complete response = no vomiting and no use of rescue medications.

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Abstract Details

Meeting

2023 ASCO Annual Meeting

Session Type

Poster Discussion Session

Session Title

Symptoms and Survivorship

Track

Symptom Science and Palliative Care

Sub Track

Palliative Care and Symptom Management

Clinical Trial Registration Number

ACTRN12616001036404

Citation

J Clin Oncol 41, 2023 (suppl 16; abstr 12019)

DOI

10.1200/JCO.2023.41.16_suppl.12019

Abstract #

12019

Poster Bd #

387

Abstract Disclosures

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