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Cannabinoids for Taxane Induced Peripheral Neuropathy

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ClinicalTrials.gov Identifier: NCT03782402
Recruitment Status : Recruiting
First Posted : December 20, 2018
Last Update Posted : September 20, 2019
Sponsor:
Information provided by (Responsible Party):
Diana Martinez, New York State Psychiatric Institute

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 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
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Brief Pain Inventory-Short Form (BPI) [ Time Frame: change over 8 weeks ]
    questionnaire


Secondary Outcome Measures :
  1. Functional Assessment of Cancer Therapy Taxane [ Time Frame: change over 8 weeks ]
    questionnaire

  2. Total Neuropathy Score (TNSc) a scale of sensory, motor and autonomic symptoms [ Time Frame: change over 8 weeks ]
    assessment of neuropathy


Eligibility Criteria
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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
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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


Contacts
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Contact: Diana Martinez, MD 646-774-7774 dm437@cumc.columbia.edu
Contact: Margaret Haney, PhD 646-774-6574 mh235@cumc.columbia.edu

Locations
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United States, New York
1051 Riverside Drive Recruiting
New York, New York, United States, 10032
Contact: Diana Martinez, MD    646-774-7774    dm437@cumc.columbia.edu   
Principal Investigator: Diana Martinez, M.D.         
Sponsors and Collaborators
New York State Psychiatric Institute
More Information
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Responsible Party: Diana Martinez, Psychiatrist II, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT03782402     History of Changes
Other Study ID Numbers: 7635
First Posted: December 20, 2018    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Taxane
Antineoplastic Agents