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

NCT07167446 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-10-22

No results posted yet for this study

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

Interventions

DRUG

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.

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.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Fox Chase Cancer Center

    lead OTHER

Principal Investigators

  • Namrata Vijayvergia, MD · Fox Chase Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-14
Primary Completion
2027-09-05
Completion
2028-09-07
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07167446 on ClinicalTrials.gov