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

NCT07167446 | Recruiting Early Phase 1 DMC FDA Drug

• 2 other identifiers: GI-2491R21CA292276-01A1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Oxaliplatin-Induced Peripheral Neuropathy (OIPN); Cannabidiol (CBD); Colorectal Cancer (CRC); Neuroprotection

Outcome Measures

Primary Outcomes (2)

• Proportion of participants adherent to the CBD supplementation protocol at Week 12, as determined by pill counts, patient self-report, and clinic compliance logs.

  Baseline through Week 12 of treatment

• Acceptability of CBD supplementation as measured by the Feasibility of Intervention Measure (FIM)

  5-point Likert scale, each item is scored 1-5. Higher scores = higher acceptability and feasibility of implementing the intervention

  Baseline through Week 12 of treatment

Secondary Outcomes (3)

• Incidence of physician-reported chemotherapy-induced peripheral neuropathy (CIPN), defined as Grade ≥2 by CTCAE v5.0.

  From baseline through end of oxaliplatin-based chemotherapy and up to 4 weeks after treatment completion (short-term follow-up)

• Change from baseline in patient-reported neuropathy symptoms using the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group Neurotoxicity (FACT-GOG NTx-13) scale

  From baseline through end of oxaliplatin-based chemotherapy and up to 4 weeks after treatment completion (short-term follow-up)

• Incidence and profile of treatment-emergent adverse events (TEAEs), as classified by CTCAE v5.0

  From baseline through end of oxaliplatin-based chemotherapy and up to 4 weeks after treatment completion (short-term follow-up)

Study Arms (2)

Cannabidiol (CBD)

EXPERIMENTAL

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

Drug: Cannabidiol (CBD); Drug: oxaliplatin-based chemotherapy

Standard of Care

ACTIVE COMPARATOR

Participants receive standard oxaliplatin-based chemotherapy without CBD supplementation

Drug: oxaliplatin-based chemotherapy

Interventions

Cannabidiol (CBD) 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.

Also known as: hemp-derived cannabidiol, CBD capsules

Cannabidiol (CBD)

oxaliplatin-based chemotherapy 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.

Cannabidiol (CBD); Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with metastatic, locally advanced unresectable colorectal cancer patients planned to receive Ox based chemotherapy in metastatic setting (at least 3 months planned).
• Subjects are allowed to have one cycle of Ox based chemotherapy before enrollment.
• ECOG PS 0-2
• No prior platinum exposure
• No evidence of ongoing neuropathy of any grade at the time of enrollment
• Patients must have marrow and organ function appropriate for systemic therapy, as per physician's discretion, but liver function should meet criteria below:
• Total Bilirubin: less than and/or equal to 1.5 X ULN
• AST(SGOT)/ALT(SGPT): less than and/or equal to 3 X ULN (5 X ULN in patients with liver metastases
• Ability to understand and willingness to sign a written informed consent and HIPAA consent document.

You may not qualify if:

• 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.
• 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.
• Untreated brain metastases (can increase seizure risk), or treated brain metastases on anti-seizure medications.
• 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.
• Concomitant treatment with strong inducers of CYP3A4 and/or strong inducers of CYP2C19.
• Underlying history of epilepsy/recurrent seizure disorder or unexplained seizure within past 6 months.
• 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)
• Recent history or clinical concern for major depression with suicidal ideation as determined by investigator assessment at baseline
• 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).
• 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).
• Patients may not be receiving any other investigational agents.

Sponsors & Collaborators

• Fox Chase Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Namrata Vijayvergia, MD

  Fox Chase Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Namrata Vijayvergia, MD

CONTACT

2152141676; Namrata.Vijayvergia@fccc.edu

Henkel Valentine, PhD

CONTACT

2152141600; henkel.valentine@fccc.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2025
• First Posted: September 11, 2025
• Study Start: October 14, 2025
• Primary Completion (Estimated): September 5, 2027
• Study Completion (Estimated): September 7, 2028
• Last Updated: October 22, 2025

Record last verified: 2025-10

Locations

US (1)