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Trial record 9 of 195 for:    Neuropathy | New York, United States

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE December 18, 2018
First Posted Date  ICMJE December 20, 2018
Last Update Posted Date September 20, 2019
Actual Study Start Date  ICMJE September 1, 2019
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 18, 2018)
Brief Pain Inventory-Short Form (BPI) [ Time Frame: change over 8 weeks ]
questionnaire
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03782402 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 18, 2018)
  • Functional Assessment of Cancer Therapy Taxane [ Time Frame: change over 8 weeks ]
    questionnaire
  • Total Neuropathy Score (TNSc) a scale of sensory, motor and autonomic symptoms [ Time Frame: change over 8 weeks ]
    assessment of neuropathy
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cannabinoids for Taxane Induced Peripheral Neuropathy
Official Title  ICMJE The Effect of Dispensed Cannabis on Taxane Induced Peripheral Neuropathy
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chemotherapy-induced Peripheral Neuropathy
Intervention  ICMJE Drug: Cannabinoids
Cannabinoids with different concentrations of THC and CBD
Study Arms  ICMJE
  • Experimental: Cannabinoids of varied strength
    Strengths of cannabinoids will vary across groups
    Intervention: Drug: Cannabinoids
  • Active Comparator: Cannabinoids of various strengths
    Strengths of cannabinoids will vary across groups
    Intervention: Drug: Cannabinoids
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 18, 2018)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2022
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 21 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Diana Martinez, MD 646-774-7774 dm437@cumc.columbia.edu
Contact: Margaret Haney, PhD 646-774-6574 mh235@cumc.columbia.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03782402
Other Study ID Numbers  ICMJE 7635
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Diana Martinez, New York State Psychiatric Institute
Study Sponsor  ICMJE New York State Psychiatric Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account New York State Psychiatric Institute
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP