Cannabinoids for Taxane Induced Peripheral Neuropathy

NCT03782402 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: 7635
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Chemotherapy-induced Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

• Brief Pain Inventory-Short Form (BPI)

  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

  value at the later time (8 weeks) point minus the value at the earlier time point (baseline)

Other Outcomes (1)

• Functional Assessment of Cancer Therapy Taxane

  Baseline and weekly until end of study.

Study Arms (2)

Cannabinoids (THC and CBD)

EXPERIMENTAL

THC and CBD

Drug: Cannabinoids

Placebo Cannabinoids

PLACEBO COMPARATOR

placebo cannabinoids

Drug: Cannabinoids

Interventions

Cannabinoids DRUG

Cannabinoids with THC and CBD versus placebo cannabinoids

Cannabinoids (THC and CBD); Placebo Cannabinoids

Eligibility Criteria

• Age: 21 Years - 60 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \) Participants with breast cancer, experiencing TIPN due to paclitaxel or docetaxel.
• \) 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).
• \) Able to give informed consent and comply with all study procedures.

You may not qualify if:

• \) Diagnosis of a major medical, neurological, or psychiatric disorder that would preclude study participation.
• \) Women who are not practicing an effective form of birth control (condoms, diaphragm, birth control pill, IUD) or currently pregnant.
• \) Subjects taking warfarin.
• \) Subjects with orthostatic hypotension, hypertension, cardiovascular disease, or neurodegenerative disorders.

Sponsors & Collaborators

• New York State Psychiatric Institute: lead

Study Sites (1)

1051 Riverside Drive

New York, New York, 10032, United States

Location

MeSH Terms

Interventions

Cannabinoids

Intervention Hierarchy (Ancestors)

Terpenes; Hydrocarbons; Organic Chemicals

Limitations and Caveats

Please note: this was a pilot study that was not funded for a full study.

Results Point of Contact

• Title: Diana Martinez
• Organization: CUIMC

dm437@cumc.columbia.edu

646-774-6160

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychiatrist II

Study Record Dates

• First Submitted: December 18, 2018
• First Posted: December 20, 2018
• Study Start: September 1, 2019
• Primary Completion: August 30, 2021
• Study Completion: August 30, 2021
• Last Updated: January 26, 2023
• Results First Posted: January 26, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)