BridgeMD
New treatment option for Oxaliplatin Induced Peripheral Neuropathy in Cancer Patients
Official title Neuroprotective Potential of Cannabidiol (CBD) in Preventing Oxaliplatin (Ox)-Induced Neuropathy
ClinicalTrials.gov ID: NCT07167446
What this study is testing
What is Cannabidiol (CBD)?
Cannabidiol (CBD) is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for oxaliplatin induced peripheral neuropathy in cancer patients.
Also referred to as hemp-derived cannabidiol, CBD capsules.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients with metastatic, locally advanced unresectable colorectal cancer patients planned to receive Ox based chemotherapy in metastatic setting (at...
- people 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
You likely can't join if
- Family history of genetic/familial neuropathy and personal history of ongoing neuropathy (any grade) or nervous system disease with the potential to...
- Routine use of recreational marijuana products (defined as \> 4 times per month) or illicit drug use per self-reported history within the last 90...
- 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...
- 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...
- Concomitant treatment with strong inducers of CYP3A4 and/or strong inducers of CYP2C19.
See the full eligibility criteria
- Patients with metastatic, locally advanced unresectable colorectal cancer patients planned to receive Ox based chemotherapy in metastatic setting (at least 3 months planned).
- people 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.
- 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...
- 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...
- 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)...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.