Overview
Cannabidiol for Prevention of Chemotherapy-induced Peripheral Neuropathy
Status:
Recruiting
Recruiting
Trial end date:
2023-08-30
2023-08-30
Target enrollment:
0
0
Participant gender:
All
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 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Zealand University HospitalCollaborator:
University of CopenhagenTreatments:
CannabidiolEpidiolex
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.