Oxaliplatin Induced Peripheral Neuropathy in Cancer PatientsEarly Phase 1NCT07167446
Neuroprotective Potential of Cannabidiol (CBD) in Preventing Oxaliplatin (Ox)-Induced Neuropathy
A Early Phase 1 study testing Cannabidiol (CBD) and oxaliplatin-based chemotherapy in people with Oxaliplatin Induced Peripheral Neuropathy in Cancer Patients and Metastatic Colorectal Cancer (CRC), run by Fox Chase Cancer Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oxaliplatin Induced Peripheral Neuropathy in Cancer Patients, Metastatic Colorectal Cancer (CRC), Peripheral Neuropathy Due to Chemotherapy
- What is being tested?
- Cannabidiol (CBD) and oxaliplatin-based chemotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 2025to 7 Sep 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
- 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.
- 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.
- 1Untreated 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Namrata Vijayvergia, 215-214-1676, namrata.vijayvergia@fccc.edu
About this study
Official title: Exploring the Neuroprotective Potential of Cannabidiol (CBD) in Preventing Oxaliplatin (Ox)-Induced Neuropathy: A Prospective Study
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.
Read the 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
- Being tested
- Cannabidiol (CBD), oxaliplatin-based chemotherapy
- Keywords
- Oxaliplatin-Induced Peripheral Neuropathy (OIPN), Cannabidiol (CBD), Colorectal Cancer (CRC), Neuroprotection
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cannabidiol (CBD)Drug
Also called hemp-derived cannabidiol, CBD capsules
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 chemotherapyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Cannabidiol (CBD) | Experimental | Participants receive hemp-derived cannabidiol (CBD) capsules in addition to standard oxaliplatin-based chemotherapy. Receives: Drug: Cannabidiol (CBD); Drug: oxaliplatin-based chemotherapy |
| Standard of Care | Active comparator | Participants receive standard oxaliplatin-based chemotherapy without CBD supplementation Receives: Drug: oxaliplatin-based chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants adherent to the CBD supplementation protocol at Week 12, as determined by pill counts, patient self-report, and clinic compliance logs.
Measured: 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
Measured: 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.
Measured: 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
Each item is scored on a 5-point Likert scale (0 = Not at all to 4 = Very much).
Total scores range from 0 to 52, with higher scores indicating more severe neuropathy symptoms
Measured: 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
Measured: From baseline through end of oxaliplatin-based chemotherapy and up to 4 weeks after treatment completion (short-term follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start14 Oct 2025
- Primary completion5 Sep 2027 (estimated)
- Study completion7 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxaliplatin Induced Peripheral Neuropathy in Cancer PatientsStudies of the same condition, open and under way.
- More trials run by Fox Chase Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Namrata Vijayvergia, MD, Principal investigator, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07167446
- Sponsor's protocol ID
- GI-249
- Other IDs
- 1R21CA292276-01A1
- Status last verified
- Oct 2026
- First submitted
- 27 Aug 2025
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Neuroprotective Potential of Cannabidiol (CBD) in Preventing Oxaliplatin (Ox)-Induced Neuropathy: A Prospective Study
- ClinicalTrials.gov ID
- NCT07167446
- Acronym / sponsor ID
- GI-249
- 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
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 14 Oct 2025 (actual)
- Primary completion
- 5 Sep 2027 (estimated)
- Study completion
- 7 Sep 2028 (estimated)
- First posted
- 11 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cannabidiol (CBD) | Experimental | Drug: Cannabidiol (CBD), Drug: oxaliplatin-based chemotherapyParticipants receive hemp-derived cannabidiol (CBD) capsules in addition to standard oxaliplatin-based chemotherapy. |
| Standard of Care | Active comparator | Drug: oxaliplatin-based chemotherapyParticipants receive standard oxaliplatin-based chemotherapy without CBD supplementation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (12 listed)
- 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.
- 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.
- 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.
- 1Untreated 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cannabidiol (CBD)Also: hemp-derived cannabidiol, CBD capsulesOral 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 | Cannabidiol (CBD) |
| oxaliplatin-based chemotherapyStandard 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. | Drug | Cannabidiol (CBD), Standard of Care |
Primary outcome
Proportion of participants adherent to the CBD supplementation protocol at Week 12, as determined by pill counts, patient self-report, and clinic compliance logs.
Time frame: Baseline through Week 12 of treatment
Acceptability of CBD supplementation as measured by the Feasibility of Intervention Measure (FIM)
Time frame: Baseline through Week 12 of treatment
5-point Likert scale, each item is scored 1-5. Higher scores = higher acceptability and feasibility of implementing the intervention
3 secondary outcomes
Incidence of physician-reported chemotherapy-induced peripheral neuropathy (CIPN), defined as Grade ≥2 by CTCAE v5.0.
Time frame: 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
Time frame: 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
Time frame: From baseline through end of oxaliplatin-based chemotherapy and up to 4 weeks after treatment completion (short-term follow-up)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Namrata Vijayvergia, MD principal investigator
Fox Chase Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Cannabidiol (CBD) and oxaliplatin-based chemotherapy in people with Oxaliplatin Induced Peripheral Neuropathy in Cancer Patients and Metastatic Colorectal Cancer (CRC), run by Fox Chase Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Namrata Vijayvergia, MD (2152141676, Namrata.Vijayvergia@fccc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants adherent to the CBD supplementation protocol at Week 12, as determined by pill counts, patient self-report, and clinic compliance logs. (time frame: Baseline through Week 12 of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.