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. 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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chemotherapy-induced Peripheral Neuropathy | Drug: Cannabinoids | Phase 2 |
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 |

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 |
- 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
- Functional Assessment of Cancer Therapy Taxane [ Time Frame: Baseline and weekly until end of study. ]

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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 |
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
United States, New York | |
1051 Riverside Drive | |
New York, New York, United States, 10032 |
Documents provided by Diana Martinez, New York State Psychiatric Institute:
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 |
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 |