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Cannabinoids for Taxane Induced Peripheral Neuropathy

Primary Purpose

Chemotherapy-induced Peripheral Neuropathy

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cannabinoids
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chemotherapy-induced Peripheral Neuropathy

Eligibility Criteria

21 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • 1051 Riverside Drive

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Cannabinoids (THC and CBD)

Placebo Cannabinoids

Arm Description

THC and CBD

placebo cannabinoids

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 18, 2018
Last Updated
January 3, 2023
Sponsor
New York State Psychiatric Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03782402
Brief Title
Cannabinoids for Taxane Induced Peripheral Neuropathy
Official Title
The Effect of Dispensed Cannabis on Taxane Induced Peripheral Neuropathy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Terminated
Why Stopped
Funding being sought
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
August 30, 2021 (Actual)
Study Completion Date
August 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy-induced Peripheral Neuropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cannabinoids (THC and CBD)
Arm Type
Experimental
Arm Description
THC and CBD
Arm Title
Placebo Cannabinoids
Arm Type
Placebo Comparator
Arm Description
placebo cannabinoids
Intervention Type
Drug
Intervention Name(s)
Cannabinoids
Intervention Description
Cannabinoids with THC and CBD versus placebo cannabinoids
Primary Outcome Measure Information:
Title
Brief Pain Inventory-Short Form (BPI)
Description
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
Time Frame
value at the later time (8 weeks) point minus the value at the earlier time point (baseline)
Other Pre-specified Outcome Measures:
Title
Functional Assessment of Cancer Therapy Taxane
Time Frame
Baseline and weekly until end of study.

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
1051 Riverside Drive
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Cannabinoids for Taxane Induced Peripheral Neuropathy

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