Trials / Withdrawn
WithdrawnNCT05672342
Phytocannabinoids for the Treatment of Chronic Chemotherapy-Induced Peripheral Neuropathy in Breast and Colon Cancer Survivors
A Pilot Study to Evaluate the Benefits of Phytocannabinoids for the Treatment of Chronic Chemotherapy-Induced Peripheral Neuropathy
- Status
- Withdrawn
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- City of Hope Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This clinical trial tests how well phytocannabinoids (cannabidiol \[CBD\] and tetrahydrocannbinol \[THC\]) work in reducing chronic chemotherapy-induced peripheral neuropathy (CIPN) in breast and colon cancer survivors. Neuropathy is the most common neurological symptom reported by cancer patients due to treatment. A variety of pharmacologic treatments have been evaluated to alleviate CIPN symptoms; however, no definitive treatment has been found to successfully treat all the symptoms of CIPN. Therefore, investigators continue to seek other possible treatment options including cannabis. Phytocannabinoids may be a particularly useful intervention for cancer patients given the limited effective treatments for CIPN. In addition, cannabis-based medicines have become tremendously popular as both cancer patients and clinicians are seeking therapies with fewer potential risks of dependency and other side effects. This trial is being done to provide cancer patients and clinicians with reliable information to help guide their use of phytocannabinoids to manage the tremendous distress and pain experienced by many cancer patients, which impacts their long-term quality of life.
Detailed description
PRIMARY OBJECTIVE: I. Assess the ability of CBD and THC:CBD to reduce CIPN symptoms as compared to placebo using the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group (FACT/GOG)-Neurotoxicity (Ntx) subscale among breast and colon cancer survivors. SECONDARY OBJECTIVES: I. Evaluate the impact of CBD and THC:CBD as compared to placebo on quality of life using the Functional Assessment of Cancer Therapy General (FACT-G) among breast and colon cancer survivors with chronic CIPN. II. Document the utilization of neuropathic and pain medications by cancer patients with chronic CIPN during treatment with CBD and THC:CBD as compared to placebo. III. Describe the side effects of CBD and THC:CBD treatment. EXPLORATORY OBJECTIVES: I. Assess neurological symptoms and function with the Neuropathy Pain Scale (NPS), Total Neuropathy Sccore - clinically based (TNSc), quantitative sensory testing (QST), Grooved Pegboard Test (GPT), and Unipedal Stance balance test (USBT) among patients with chronic CIPN treated with CBD and THC:CBD as compared to placebo. II. Evaluate for predictors of response to CBD and THC:CBD for chronic CIPN. OUTLINE: This is a dose-escalation study of CBD and THC. Patients are randomized to 1 of 3 arms. ARM I: Patients receive CBD orally (PO) on study. ARM II: Patients receive CBD PO + THC PO on study. ARM III: Patients receive placebo PO on study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Cannabidiol | Given PO |
| DRUG | Delta-8-Tetrahydrocannabinol | Given PO |
| DRUG | Placebo Administration | Given PO |
| OTHER | Questionnaire Administration | Ancillary studies |
Timeline
- Start date
- 2024-07-06
- Primary completion
- 2025-10-31
- Completion
- 2025-10-31
- First posted
- 2023-01-05
- Last updated
- 2024-08-09
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05672342. Inclusion in this directory is not an endorsement.