Cannabinoids for Taxane Induced Peripheral Neuropathy

Phase 2

Terminated

• Conditions: Chemotherapy-induced Peripheral Neuropathy
• Interventions: Drug: Cannabinoids

• Registration Number: NCT03782402
• Lead Sponsor: New York State Psychiatric Institute

Brief 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.

Detailed Description

The investigators' goal is to study the efficacy of cannabinoids as a potential treatment for TIPN. Volunteers with a diagnosis of breast cancer and chemotherapy-induced peripheral neuropathy, secondary to treatment with paclitaxel or docetaxel, will be enrolled. This study involves the administration of cannabinoids in different strength capsules. The primary outcome measures include measures of pain and functional impairment (non-painful symptoms). The scales will include: 1) Brief Pain Inventory-Short Form (BPI) for pain severity ; and 2) BPI pain interference subscale for functional impairment. The study outcomes will also include secondary measures of perception, which will be performed in the laboratory.

Study Timeline

• Study First Submitted: 2018-12-18
• Study First Submitted QC: 2018-12-18
• Study First Posted: 2018-12-20
• Study Start: 2019-09-01
• Primary Completion: 2021-08-30
• Study Completion: 2021-08-30
• Results First Submitted: 2022-08-02
• Status Verified: 2022-11
• Results First Submitted QC: 2023-01-03
• Last Update Submitted: 2023-01-03
• Results First Posted: 2023-01-26
• Last Update Posted: 2023-01-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cannabinoids (THC and CBD)	Cannabinoids	THC and CBD
Placebo Cannabinoids	Cannabinoids	placebo cannabinoids

Primary Outcome Measures

Name	Time	Method
Brief Pain Inventory-Short Form (BPI)	value at the later time (8 weeks) point minus the value at the earlier time point (baseline)	This is a standard questionnaire to measure pain.It is used to evaluate pain through a number of different scales. Patients fill out 11 different questions that ask about pain intensity (present and least, most, and average for the past 24 hours) and the effect of the pain on the ability to function during various activities of daily living. Higher number is worse. range is 0 to 10

Trial Locations

Locations (1)

1051 Riverside Drive; 🇺🇸 New York, New York, United States