Cannabinoids for Taxane Induced Peripheral Neuropathy

Sponsor

New York State Psychiatric Institute (Other)

Overall Status

Terminated

CT.gov ID

NCT03782402

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chemotherapy-induced Peripheral Neuropathy	Drug: Cannabinoids	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

The Effect of Dispensed Cannabis on Taxane Induced Peripheral Neuropathy

Actual Study Start Date :

Sep 1, 2019

Actual Primary Completion Date :

Aug 30, 2021

Actual Study Completion Date :

Aug 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cannabinoids of varied strength Strengths of cannabinoids will vary across groups	Drug: Cannabinoids Cannabinoids with different concentrations of THC and CBD
Active Comparator: Cannabinoids of various strengths Strengths of cannabinoids will vary across groups	Drug: Cannabinoids Cannabinoids with different concentrations of THC and CBD

Arm

Intervention/Treatment

Experimental: Cannabinoids of varied strength

Strengths of cannabinoids will vary across groups

Drug: Cannabinoids

Cannabinoids with different concentrations of THC and CBD

Active Comparator: Cannabinoids of various strengths

Strengths of cannabinoids will vary across groups

Drug: Cannabinoids

Cannabinoids with different concentrations of THC and CBD

Outcome Measures

Primary Outcome Measures

Brief Pain Inventory-Short Form (BPI) [change over 8 weeks]
questionnaire

Secondary Outcome Measures

Functional Assessment of Cancer Therapy Taxane [change over 8 weeks]
questionnaire
Total Neuropathy Score (TNSc) a scale of sensory, motor and autonomic symptoms [change over 8 weeks]
assessment of neuropathy

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

1. Participants with breast cancer, experiencing TIPN due to paclitaxel or docetaxel.
1. 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).
1. 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.
1. Women who are not practicing an effective form of birth control (condoms, diaphragm, birth control pill, IUD) or currently pregnant.
1. Subjects taking warfarin.
1. Subjects with orthostatic hypotension, hypertension, cardiovascular disease, or neurodegenerative disorders.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	1051 Riverside Drive	New York	New York	United States	10032

Sponsors and Collaborators

New York State Psychiatric Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Diana Martinez, Psychiatrist II, New York State Psychiatric Institute

ClinicalTrials.gov Identifier:

NCT03782402

Other Study ID Numbers:

7635

First Posted:

Dec 20, 2018

Last Update Posted:

Feb 18, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Peripheral Nervous System Diseases

Study Results

No Results Posted as of Feb 18, 2022