CBD tested as shield against Chemo's nerve pain
NCT ID NCT07167446
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial tests whether taking CBD capsules can prevent nerve damage caused by the chemotherapy drug oxaliplatin in people with colorectal cancer. Thirty participants will be randomly assigned to receive either CBD plus standard chemo or chemo alone. The main goal is to see if patients can stick with the CBD regimen, not yet to prove it works.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- cannabidiol (CBD) capsules
- What this could lead to
- If it works, this could point toward a way to prevent painful nerve damage from chemotherapy, improving quality of life for cancer patients.
- What could go wrong
- This is a very early, small pilot study with only 30 people. It mainly tests feasibility, not effectiveness. CBD may not prevent neuropathy, and side effects or interactions with chemo are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Sep 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patients with metastatic, locally advanced unresectable colorectal cancer patients planned to receive Ox based chemotherapy in metastatic setting (at least 3 months planned). 2. Subjects are allowed to have one cycle of Ox based chemotherapy before enrollment. 3. ECOG PS 0-2 4. No prior platinum exposure 5. No evidence of ongoing neuropathy of any grade at the time of enrollment 6. Patients must have marrow and organ function appropriate for systemic therapy, as per physician's discretion, but liver function should meet criteria below: 1. Total Bilirubin: less than and/or equal to 1.5 X ULN 2. AST(SGOT)/ALT(SGPT): less than and/or equal to 3 X ULN (5 X ULN in patients with liver metastases 7. Ability to understand and willingness to sign a written informed consent and HIPAA consent document. Exclusion Criteria: 8. Family history of genetic/familial neuropathy and personal history of ongoing neuropathy (any grade) or nervous system disease with the potential to affect cognition, Parkinson's disease, or multiple sclerosis. 9. Routine use of recreational marijuana products (defined as \> 4 times per month) or illicit drug use per self-reported history within the last 90 days. If using medical cannabis products, it should be stopped at least 1 week prior to inclusion. 10. Known underlying liver disease (Child-Pugh B or C) or baseline elevation of total bilirubin greater than and/or equal to 1.5 x upper limit of normal based on screening laboratory values. 11. 1Untreated brain metastases (can increase seizure risk), or treated brain metastases on anti-seizure medications. 12. Patients being treated with anti-seizure or anti-psychotic medications. Patients with a prior history of anti-seizure medication use, who have been off treatment for more than 3 months, are eligible. Use of Selective Serotonin Reuptake Inhibitors (SSRIs) is permitted. 13. Concomitant treatment with strong inducers of CYP3A4 and/or strong inducers of CYP2C19. 14. Underlying history of epilepsy/recurrent seizure disorder or unexplained seizure within past 6 months. 15. Patients with current or lifetime diagnosis of schizophrenia spectrum disorder, psychotic disorder, bipolar disorder type I \& II, cluster B personality disorders (antisocial, borderline, narcissistic, histrionic), eating disorders, as defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revised (DSM-5-TR, APA 2022) 16. Recent history or clinical concern for major depression with suicidal ideation as determined by investigator assessment at baseline 17. Currently taking medications known to be contraindicated with Epidiolex -FDA-approved CBD (buprenorphine, leflunomide, levomethadyl acetate, lomitapide, mipomersen, pexidartinib, propoxyphene, sodium oxybate, teriflunomide, clobazam, lamotrigine, valproate). 18. Women who are pregnant or breastfeeding, and individuals of any sex who are capable of reproduction and unwilling to use an effective form of birth control (e.g., condoms, diaphragm, birth control pills, or IUD). 19. Patients may not be receiving any other investigational agents.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Fox Chase Cancer Center
RECRUITINGPhiladelphia, Pennsylvania, 19111, United States
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Other studies related to the condition(s) this trial covers.
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- Can mindfulness together ease the burden of advanced cancer?
- Can a Two-Pronged attack shrink Hard-to-Treat colorectal tumors?
- Blood test may reveal hidden cancer spread without scans