Status:
TERMINATED
Cannabinoids for Taxane Induced Peripheral Neuropathy
Lead Sponsor:
New York State Psychiatric Institute
Conditions:
Chemotherapy-induced Peripheral Neuropathy
Eligibility:
FEMALE
21-60 years
Phase:
PHASE2
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 th...
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, seconda...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2021
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03782402
Start Date
September 1 2019
End Date
August 30 2021
Last Update
January 26 2023
Active Locations (1)
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1
1051 Riverside Drive
New York, New York, United States, 10032