Neuroprotective Potential of Cannabidiol (CBD) in Preventing Oxaliplatin (Ox)-Induced Neuropathy

NCT ID: NCT07167446

Last Updated: 2025-10-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-14
• Study Completion Date: 2028-09-07

Brief Summary

This is a pilot, prospective, randomized study evaluating the feasibility and acceptability of incorporating hemp-derived cannabidiol (CBD) supplementation to prevent oxaliplatin-induced peripheral neuropathy (OIPN) in patients receiving oxaliplatin-based chemotherapy for colorectal cancer (CRC). Participants will be randomized to receive either CBD capsules in addition to standard therapy or standard therapy alone.

Detailed Description

Patients with metastatic colorectal cancer (mCRC) scheduled to receive at least 3 months of oxaliplatin-based chemotherapy will be enrolled on this prospective, randomized, open-label pilot study. A total of 30 patients will be randomized 2:1, with 20 patients assigned to the CBD supplementation arm and 10 patients assigned to the standard of care arm. Patients with pre-existing neuropathy, prior oxaliplatin exposure, or active cannabinoid use will be excluded.

Patients in the intervention arm will receive hemp-derived CBD capsules at a dose of 150 mg orally twice daily (following a titration during Cycle 1) starting the day before oxaliplatin and continuing through 7 days after each chemotherapy cycle. Standard oxaliplatin-based chemotherapy will be administered every 2-3 weeks per NCCN guidelines. Compliance will be monitored through pill counts, patient reporting, and scheduled check-ins. Dose adjustments to 100 mg or 50 mg twice daily will be permitted for treatment-related adverse events at investigator discretion.

Neuropathy will be assessed using both physician grading (CTCAE v5) and patient-reported outcomes (FACT-GOG NTx-13). Safety monitoring will include laboratory tests, neurological and physical examinations, and psychiatric evaluation with the Columbia Suicide Severity Rating Scale (C-SSRS). Exploratory analyses will measure circulating inflammatory cytokines (IL-6, TNF-α) and neuropathy-associated microRNAs (miR-155, miR-146a).

A total of 30 patients (20 intervention, 10 control) will be enrolled at Fox Chase Cancer Center over a 2-year period.

Conditions

Oxaliplatin Induced Peripheral Neuropathy in Cancer Patients; Metastatic Colorectal Cancer (CRC); Peripheral Neuropathy Due to Chemotherapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Cannabidiol (CBD)

Participants receive hemp-derived cannabidiol (CBD) capsules in addition to standard oxaliplatin-based chemotherapy.

Group Type: EXPERIMENTAL

Cannabidiol (CBD)

Intervention Type: DRUG

Oral hemp-derived CBD capsules, 150 mg twice daily (with titration in Cycle 1; dose reductions permitted for tolerability). Administered starting the day before oxaliplatin infusion and continued for 7 days after each chemotherapy cycle.

oxaliplatin-based chemotherapy

Intervention Type: DRUG

Standard of care oxaliplatin-based regimens per NCCN guidelines (e.g., FOLFOX or CAPEOX), administered in 2-3 week cycles for a maximum of 6 months.

Standard of Care

Participants receive standard oxaliplatin-based chemotherapy without CBD supplementation

Group Type: ACTIVE_COMPARATOR

oxaliplatin-based chemotherapy

Intervention Type: DRUG

Standard of care oxaliplatin-based regimens per NCCN guidelines (e.g., FOLFOX or CAPEOX), administered in 2-3 week cycles for a maximum of 6 months.

Interventions

Cannabidiol (CBD)

Oral hemp-derived CBD capsules, 150 mg twice daily (with titration in Cycle 1; dose reductions permitted for tolerability). Administered starting the day before oxaliplatin infusion and continued for 7 days after each chemotherapy cycle.

Intervention Type: DRUG

oxaliplatin-based chemotherapy

Standard of care oxaliplatin-based regimens per NCCN guidelines (e.g., FOLFOX or CAPEOX), administered in 2-3 week cycles for a maximum of 6 months.

Intervention Type: DRUG

Other Intervention Names

hemp-derived cannabidiol; CBD capsules

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Fox Chase Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Namrata Vijayvergia, MD

Role: PRINCIPAL_INVESTIGATOR

Fox Chase Cancer Center

Locations

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Namrata Vijayvergia, MD

Role: CONTACT

Namrata.Vijayvergia@fccc.edu

2152141676

Henkel Valentine, PhD

Role: CONTACT

henkel.valentine@fccc.edu

2152141600

Facility Contacts

Namrata Vijayvergia

Role: primary

namrata.vijayvergia@fccc.edu

215-214-1676

Other Identifiers

1R21CA292276-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

GI-249

Identifier Type: -

Identifier Source: org_study_id