None listed
Conditions
Brief summary
This study aims to determine if ibudilast, an anti-inflammatory drug, can prevent acute neurotoxicity and chemotherapy induced peripheral neuropathy. Who is it for? You may be eligible if you are over 18 years old, have been diagnosed with metastatic gastrointestinal cancer and have at least two cycles of chemotherapy with oxaliplatin planned. Study details Participants will be required to take the study drug, twice a day, for one cycle of chemotherapy treatment (2-3 weeks depending on the length of the chemotherapy cycle). Participants will also be observed for one cycle of chemotherapy treatment. Participants will also need to complete questionnaires, take blood tests and complete a physical assessment with a clinician. This will occur at the beginning of the study, during the chemotherapy cycles and one more time 3 months later. This study will help to inform research into minimising side effects for patients while undergoing chemotherapy.
Interventions
Ibudilast is a non-selective phosphodiesterase (PDE) inhibitor with anti-inflammatory properties which has shown to improve acute neurotoxicity in animal models. The study intervention will be oral ibudilast 30mg twice daily for the duration of one cycle, named Cycle B. The duration of the cycle is 2 weeks for patients receiving infusional fluorouracil with oxaliplatin (FOLFOX) and 3 weeks for patients receiving oral capecitabine with oxaliplatin (CapeOx). There is no washout period. Drug tablet
Ibudilast is a non-selective phosphodiesterase (PDE) inhibitor with anti-inflammatory properties which has shown to improve acute neurotoxicity in animal models. The study intervention will be oral ibudilast 30mg twice daily for the duration of one cycle, named Cycle B. The duration of the cycle is 2 weeks for patients receiving infusional fluorouracil with oxaliplatin (FOLFOX) and 3 weeks for patients receiving oral capecitabine with oxaliplatin (CapeOx). There is no washout period. Drug tablet return at the end of the cycle and weekly phone contact will be used to monitor adherence to the intervention.
Sponsors
Concord Cancer Centre
Study design
Allocation
Non-randomised trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of metastatic upper gastrointestinal or colorectal cancer 2. Aged > 18 years 3. Patient has received at least one prior cycle of FOLFOX or CapeOx 4. Planned to receive at least two further cycles of the same chemotherapy 5. Speak and read sufficientEnglish to answer the questionnaires 6. Normal renal function with glomerular filtration rate >90mL/min 7. Give written informed consent 8. Patient must be accessible for treatment and follow up. Investigators must assure themselves the patients will be available for complete documentation of the treatment adverse events and follow up.
Exclusion criteria
1. ECOG Performance Status of less than or equal to 2 2. 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 3. Any contraindication to taking ibudilast, including uncontrolled nausea or vomiting with chemotherapy 4. Inability to swallow capsules
Outcome results
None listed