Cannabinoids for Taxane Induced Peripheral Neuropathy

• Status: Recruiting
• Trial end date: 2025-10-31
• Target enrollment: 0
• Participant gender: Female

Summary

Taxane-induced peripheral neuropathy (TIPN) affects a significant number of women undergoing breast cancer treatment. Some patients may need to shorten their course of treatment, and do not receive the full benefit of chemotherapy as a result. Rodent studies have shown that the cannabinoids may significantly improve hyperalgesia and allodynia induced by paclitaxel. The goal of this study is to investigate the cannabinoids THC and CBD for TIPN.

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

Details

• Lead Sponsor: New York State Psychiatric Institute
• Treatments: Taxane

Criteria

Inclusion Criteria:

• 1) Participants with breast cancer, experiencing TIPN due to paclitaxel or docetaxel.

• 2) Participants must have an ECOG score of 2 or better. Participants must have a score of 2 or 3 score for sensory neuropathy, as assessed by the Common Toxicity Criteria Adverse Events (CTCAE).

• 3) Able to give informed consent and comply with all study procedures.

Exclusion Criteria:

• 1) Diagnosis of a major medical, neurological, or psychiatric disorder that would preclude study participation.

• 2) Women who are not practicing an effective form of birth control (condoms, diaphragm, birth control pill, IUD) or currently pregnant.

• 3) Subjects taking warfarin.

• 4) Subjects with orthostatic hypotension, hypertension, cardiovascular disease, or neurodegenerative disorders.