Cannabinoids for Taxane Induced Peripheral Neuropathy
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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 29, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chemotherapy-induced Peripheral Neuropathy | Drug: Cannabinoids | Phase 2 |
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 |

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

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.
Ages Eligible for Study: | 21 Years to 60 Years (Adult) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Accepts Healthy Volunteers: | No |
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.

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
Contact: Diana Martinez, MD | 646-774-7774 | dm437@cumc.columbia.edu | |
Contact: Margaret Haney, PhD | 646-774-6574 | mh235@cumc.columbia.edu |
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. |
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 |
Last Update Posted: | September 29, 2020 |
Last Verified: | September 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
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 |
Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases |