Cannabinoids for Taxane Induced Peripheral Neuropathy

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Dispensed Cannabis on Taxane Induced Peripheral Neuropathy

Conditions
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Chemotherapy-induced Peripheral Neuropathy

Intervention / Treatment
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* Drug: Cannabinoids


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cannabinoids (THC and CBD)<br>THC and CBD | Drug: Cannabinoids<br>* Cannabinoids with THC and CBD versus placebo cannabinoids<br>|
| Placebo Comparator: Placebo Cannabinoids<br>placebo cannabinoids | Drug: Cannabinoids<br>* Cannabinoids with THC and CBD versus placebo cannabinoids<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brief Pain Inventory-Short Form (BPI) | 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 | value at the later time (8 weeks) point minus the value at the earlier time point (baseline) |