Cannabinoids for Taxane Induced Peripheral Neuropathy

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2021-08-30

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.

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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.

Conditions

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Chemotherapy-induced Peripheral Neuropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Cannabinoids (THC and CBD)

THC and CBD

Group Type EXPERIMENTAL

Cannabinoids

Intervention Type DRUG

Cannabinoids with THC and CBD versus placebo cannabinoids

Placebo Cannabinoids

placebo cannabinoids

Group Type PLACEBO_COMPARATOR

Cannabinoids

Intervention Type DRUG

Cannabinoids with THC and CBD versus placebo cannabinoids

Interventions

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Cannabinoids

Cannabinoids with THC and CBD versus placebo cannabinoids

Intervention Type DRUG

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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No