The Effect of Cannabidiol on Lean Body Mass in Patients Receiving Chemotherapy

• Status: Recruiting
• Trial end date: 2021-12-30
• Target enrollment: 0
• Participant gender: All

Summary

An intervention study on the effect of cannabidiol on lean body mass in cancer patients receiving chemotherapy, at the department of Clinical Oncology at Zealand University Hospital, Roskilde, Denmark. Fat free mass will be measured by bioimpedance spectroscopy. As secondary outcomes protein and energy intake, nausea, taste alterations and life quality will be assessed by oral interviews and questionnaires.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Copenhagen
• Collaborator: Zealand University Hospital
• Treatments: Cannabidiol; Epidiolex

Criteria

Inclusion Criteria:

• A diagnosis of cancer

• Fulfill criteria for starting chemotherapy

• Must be able to stand upright

• Have the possibility of contact by telephone

• No previous treatment with taxanes or platinums

• Scheduled to undergo lest 4 courses of paclitaxel or 4 courses of oxaliplatin based chemotherapy

• If female and fertile, must have been menopausal for 1 year or negative pregnancy test at inclusion and use approved contraceptive measures

Exclusion Criteria:

• Pregnant

• Breastfeeding

• Unable to complete patient reported outcomes (PRO)-measurements

• Previously received taxanes or platinum-based chemotherapy

• Use of cannabinoids. If in use, treatment must be stopped 4 days prior to inclusion

• If using any anti epileptic or antidepressant medicine. Treatment must be stable (no changes in dosing in last 30 days) prior to inclusion. However, any treatment with Clobazam is not allowed due to major interaction with cannabidiol.