OXTOX: Can Oxaliplatin neurotoxicity be reduced with ibudilast in people with metastatic colorectal cancer – a phase II randomised study
Australasian Gastro-Intestinal Trials Group
100 participants
Jan 28, 2021
Interventional
Conditions
Summary
Oxaliplatin chemotherapy improves survival but causes acute neuropathy (paraesthesias or dysesthesias) and chronic chemotherapy-induced peripheral neuropathy (CIPN) in almost all patients. CIPN can last for months to years, and can have a major impact on quality of life. It is suggested that ibudilast can prevent and treat this neurotoxicity. The purpose of this study is to determine if ibudilast can safely and effectively decrease neurotoxicity in patients receiving chemotherapy. Who is it for? You may be eligible for this study if you are an adult who has been diagnosed with metastatic colorectal cancer, and will be commencing chemotherapy with oxaliplatin. Study details Participants in this study will continue with their prescribed chemotherapy. As part of this study, participants will be randomly allocated to one of two groups: 1. Ibudilast taken twice a day for the duration of oxaliplatin, and 2. Placebo capsules, taken twice a day for the same period. Participants will complete questionnaires and be examined by their usual oncologist. Results of usual blood tests and imaging will be reviewed. It is hoped that this research will help determine if ibudilast can be effective in reducing neurotoxicity in participants. If it is shown to be effective, it may allow more chemotherapy to be delivered, and therefore may improve survival rates in people with colorectal cancer.
Eligibility
Inclusion Criteria7
- Diagnosis of histologically confirmed metastatic adenocarcinoma CRC who are to commence chemotherapy with oxaliplatin (i.e. FOLFOX or CAPOX).
- Agents such as Bevacizumab may be included with the oxaliplatin regimen.
- Patients who are to receive an oxaliplatin regimen prior to planned surgery for metastatic CRC may be included if a minimum of 3 months of oxaliplatin treatment is planned.
- Speak and read sufficient English to answer the questionnaires.
- Adequate organ function, defined as renal function with glomerular filtration rate >50mL/min, adequate bone marrow (platelets >100 X 109 L-1, neutrophil count >1.5 X 109 L-1), and hepatic (ALT, AST or total bilirubin <3 X the upper limit of normal (ULN).
- Give written informed consent.
- Concomitant use of analgesics that are being used for purposes other than peripheral neuropathy but that have efficacy in neuropathy pain such as gabapentin and pregabalin and selective serotonin reuptake inhibitors (SSRIs), are allowed as long as the dose is expected to be consistent throughout the trial.
Exclusion Criteria6
- ECOG Performance Status of 3 or above.
- Existing peripheral neuropathy of any grade (e.g. due to diabetes mellitus, B12 deficiency, alcohol abuse, or use of nucleoside reverse transcriptase inhibitors).
- Prior adjuvant treatment with oxaliplatin within the past 12 months; or any prior treatment with oxaliplatin for metastatic disease regardless of the time frame.
- Any major active psychiatric illness, dementia, or alcohol abuse that in the opinion of the principal investigator may interfere with their ability to complete neurotoxicity assessments.
- Any contraindication to taking ibudilast, including uncontrolled nausea or vomiting with chemotherapy.
- Inability to swallow capsules.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Ibudilast 30mg oral twice a day for prevention of acute neurotoxicity for the duration of taking oxaliplatin chemotherapy commencing 2 days prior to starting oxaliplatin.
Locations(10)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12619000566134