Cannabidiol for Prevention of Chemotherapy-induced Peripheral Neuropathy

• Status: Recruiting
• Trial end date: 2023-08-30
• Target enrollment: 0
• Participant gender: All

Summary

This protocol describes a phase II trial investigating the efficacy of CBD in paclitaxel- and oxaliplatin-induced peripheral neuropathy. The trial uses multiple assessments such as validated PRO-questionnaires and multifrequency vibrometry.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• ≥ 18 years of age.

• A diagnosis of cancer.

• Fulfill criteria for starting chemotherapy.

• Scheduled to undergo at least 6 courses of paclitaxel or 4 courses of oxaliplatin based chemotherapy.

• If not postmenopausal (defined as no menses for 12 months without an alternative medical cause), women will have use effective anti-contraception (using definitions in the CTFG*-Recommendations related to contraception and pregnancy testing in clinical trials) and submit to a monthly pregnancy test (blood test).

Exclusion Criteria:

• Unable to complete PRO-measurements.

• Previously received taxanes or platinum-based chemotherapy.

• If using any antiepileptic or antidepressant medicine (ATC: N03A or N06A). Treatment must be stable (no changes in dosing in last 30 days) prior to inclusion. However, any treatment with Clobazam (N05BA09) is not allowed due to major interaction with cannabidiol.

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

• Hypersensitivity reactions towards Ascorbylpalmitat or Triglycerides (medium-chain)

• Baseline transaminase level must not be above 3 times the Upper Limit of Normal (ULN) at study beginning.

• Women who are breastfeeding.

• Concomitant treatment with strong inducers of CYP3A4 and/or strong inducers of CYP2C19.

CTFG: The Heads of Medicines Agencies commissioned Clinical Trials Facilitation Group under the European Union's clinical trials directive 2001/20.