Actively Recruiting
Phytocannabinoids for Reducing Chronic Chemotherapy-Induced Peripheral Neuropathy in Breast and Colon Cancer Survivors
Led by City of Hope Medical Center · Updated on 2025-12-05
120
Participants Needed
2
Research Sites
118 weeks
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase II trials evaluates how well different types of phytocannabinoids (cannabidiol \[CBD\] versus tetrahydrocannabinol \[THC\] and CBD formulation \[THC:CBD\]) work to reduce chronic chemotherapy-induced peripheral neuropathy among breast and colon cancer survivors. Chemotherapy induced peripheral neuropathy is a set of symptoms that includes pain, tingling, numbness and motor weakness caused by certain types of chemotherapy treatment. Phytocannabinoids are compounds made by the cannabis plant, such as THC and CBD, that have been found to be an effective treatment for chronic pain. Phytocannabinoids may be effective in reducing chronic chemotherapy-induced peripheral neuropathy symptoms in patients treated for breast or colon cancer.
CONDITIONS
Official Title
Phytocannabinoids for Reducing Chronic Chemotherapy-Induced Peripheral Neuropathy in Breast and Colon Cancer Survivors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Documented informed consent of the participant and/or legally authorized representative
- Agreement to allow use of archival tissue from diagnostic tumor biopsies (exceptions with PI approval)
- Willingness to comply with study treatments including medical cannabis use and follow-up
- Age 18 years or older
- Eastern Cooperative Oncology Group Performance Status of 2 or less
- Ability to read and understand English for questionnaires
- Neuropathy of grade 1 or higher by CTCAE v5.0 or neuropathy score above 3 plus FACT/GOG-Ntx score above 10
- Previous chemotherapy including taxane or platinum drugs considered cause of neuropathy
- Total bilirubin 1.5 times upper limit of normal or less (unless Gilbert's disease)
- AST and ALT 3 times upper limit of normal or less
- Negative pregnancy test for women of childbearing potential
- Agreement to use effective birth control or abstain from heterosexual activity during study and 1 month after
You will not qualify if you...
- Active chemotherapy, radiation, or surgery within past 3 months or planned during study (hormonal therapy allowed)
- Neuropathic chemotherapy treatment within past 6 months
- Use of other alternative medicines including medical cannabis, herbal agents, or high-dose vitamins and minerals
- Liver cirrhosis classified as Child-Pugh B or C
- Mental or psychological disorders that impair study cooperation
- History of diabetic neuropathy, HIV-related neuropathy, or other chronic neuropathies
- Medical cannabis use within 30 days before enrollment
- Planned or actual medication changes affecting CIPN symptoms; stable CIPN medication doses required for 4 weeks
- Use of strong CYP3A4 inhibitors or inducers
- Allergic reactions to compounds similar to study agents
- Clinically significant uncontrolled illnesses
- Diagnosis of Gilbert's disease
- Pregnant or breastfeeding women
- Any condition that investigator judges unsafe for participation
- Inability to comply with study procedures
- Allergy or aversion to strawberry or strawberry flavoring
AI-Screening
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Trial Site Locations
Total: 2 locations
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
2
City of Hope at Irvine Lennar
Irvine, California, United States, 92618
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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