Cannabinoids for Taxane Induced Peripheral Neuropathy

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Chemotherapy-induced Peripheral Neuropathy

In brief

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.

Key facts

Study ID

NCT03782402

Run by

New York State Psychiatric Institute

People needed

12

Starts

2019-09-01

Expected to finish

2021-08-30

Last updated by the study team

2023-01-26

Who can join

Age: 21 and older, up to 60. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 1051 Riverside Drive — New York, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.