We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cannabinoids for Taxane Induced Peripheral Neuropathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03782402
Recruitment Status : Terminated (Funding being sought)
First Posted : December 20, 2018
Results First Posted : January 26, 2023
Last Update Posted : January 26, 2023
Sponsor:
Information provided by (Responsible Party):
Diana Martinez, New York State Psychiatric Institute

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : September 1, 2019
Actual Primary Completion Date : August 30, 2021
Actual Study Completion Date : August 30, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Cannabinoids (THC and CBD)
THC and CBD
 Drug: Cannabinoids
Cannabinoids with THC and CBD versus placebo cannabinoids
Placebo Comparator: Placebo Cannabinoids
placebo cannabinoids
 Drug: Cannabinoids
Cannabinoids with THC and CBD versus placebo cannabinoids


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Brief Pain Inventory-Short Form (BPI) [ Time Frame: 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


Other Outcome Measures:
  1. Functional Assessment of Cancer Therapy Taxane [ Time Frame: Baseline and weekly until end of study. ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03782402


Locations
Layout table for location information
United States, New York
1051 Riverside Drive
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
  Study Documents (Full-Text)

Documents provided by Diana Martinez, New York State Psychiatric Institute:
Study Protocol, Statistical Analysis Plan, and Informed Consent Form  [PDF] August 23, 2021

More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Diana Martinez, Psychiatrist II, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT03782402    
Other Study ID Numbers: 7635
First Posted: December 20, 2018    Key Record Dates
Results First Posted: January 26, 2023
Last Update Posted: January 26, 2023
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases