Cannabinoids for Taxane Induced Peripheral Neuropathy

New York State Psychiatric Institute

Status and phase

Terminated

Phase 2

Conditions

Chemotherapy-induced Peripheral Neuropathy

Treatments

Drug: Cannabinoids

Study type

Interventional

Funder types

Other

Identifiers

NCT03782402

7635

Details and patient eligibility

About

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.

Full 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, 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.

Enrollment

12 patients

Sex

Female

Ages

21 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

1. Participants with breast cancer, experiencing TIPN due to paclitaxel or docetaxel.
1. 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).
1. 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.
1. Women who are not practicing an effective form of birth control (condoms, diaphragm, birth control pill, IUD) or currently pregnant.
1. Subjects taking warfarin.
1. Subjects with orthostatic hypotension, hypertension, cardiovascular disease, or neurodegenerative disorders.