Investigating the effect of medicinal cannabis on the symptoms and side effects of chemotherapy in people with cancer.

Phase 2

• Conditions: cancer; chemotherapy treatment side effects; mucositis; diarrhea; sleep disturbances; anorexia; Cancer - Any cancer

• Registration Number: ACTRN12622000419763
• Lead Sponsor: Central Adelaide Local Health Network (CALHN)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-03-11
• Last Update Posted: 21 March 2022

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 176

Inclusion Criteria

18 years of age or older
Scheduled to receive mucotoxic, systemic cancer therapy for advanced solid and haematological cancers.
Anticipated to undergo 3 cycles of chemotherapy (solid tumour cancer participants) OR autologous stem cell transplantation (haematological cancers – HSCT participants).
Willing to commit to not taking cannabis in any other form during the clinical trial period.
For randomisation of solid tumour participants: Gut distress symptoms related to their cancer therapy defined by a score of greater or equal to 1 in the MDQ and confirmed by research nurse.

Exclusion Criteria

Cannabis dependence / misuse defined by the revised Cannabis Use Disorder Identification test score of 8 or above.
History of unstable cardiovascular disease including myocardial infarction or cerebrovascular accident, crescendo history of angina or heart failure.
Recreational or medicinal cannabis use defined as use >once/week in the month leading up to the clinical trial period.
History of psychosis secondary to, or intolerance to cannabis products.
Presence of an active psychiatric disorder or concurrent disorder that may be exacerbated by
cannabinoids, or which may interfere with clinical trial outcome determination (determined by the recruiting clinician).
Pregnant or planning on becoming pregnant.
Currently lactating.
Involved in another clinical trial (except observational trials) or expected to start one soon after completion.
Pre-existing oral disease or disability that would impair oral-administration or mucosal absorption.
Presence of known impairment of hepatic synthetic dysfunction.
Laboratory values suggestive of liver dysfunction.

Study & Design

• Study Type: Interventional
• Study Design: Not specified