Cannabidiol for Prevention of Chemotherapy-induced Peripheral Neuropathy

NCT ID: NCT04582591

Last Updated: 2022-02-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-03
• Study Completion Date: 2023-08-30

Brief 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.

Detailed Description

Chemotherapy induced peripheral neuropathy (CIPN) is among the most feared side effects to cancer treatment. The development of CIPN can lead to omission or even discontinuation of antineoplastic drugs, possibly affecting efficacy of cancer treatment. There is a lack of knowledge about the natural course of CIPN and to this date, there are no available methods for the early detection of CIPN. With no effective prevention or treatment options, the condition has severe impact on patient quality of life and healthcare expenditure.

Conditions

Chemotherapy-induced Peripheral Neuropathy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Cannabidiol

Patients will receive cannabidiol in conjunction with their standard chemotherapy treatment

Group Type: EXPERIMENTAL

Cannabidiol 100 MG/ML

Intervention Type: DRUG

Patients receive cannabidiol before and after treatment with chemotherapy

Interventions

Cannabidiol 100 MG/ML

Patients receive cannabidiol before and after treatment with chemotherapy

Intervention Type: DRUG

Other Intervention Names

CBD

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Copenhagen

OTHER

Sponsor Role: collaborator

Zealand University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jørn Herrstedt, DMSc

Role: STUDY_CHAIR

Zealand University Hospital / University of Copenhagen

Sebastian W Nielsen, MD

Role: PRINCIPAL_INVESTIGATOR

Zealand University Hospital / University of Copenhagen

Locations

Department of Clinical Oncology and Palliative Care

Roskilde, , Denmark

Countries

Denmark

Other Identifiers

REG-114-2020

Identifier Type: -

Identifier Source: org_study_id