Ibudilast for the prevention of nerve symptoms caused by oxalipatin chemotherapy, in patients with metastatic gastrointestinal cancer

Phase 1

Completed

• Conditions: Acute neurotoxicity; Chemotherapy induced peripheral neuropathy (CIPN); Metastatic gastrointestinal cancer; Cancer - Bowel - Back passage (rectum) or large bowel (colon); Cancer - Bowel - Anal; Neurological - Other neurological disorders; Cancer - Bowel - Small bowel (duodenum and ileum); Cancer - Stomach; Cancer - Pancreatic; Cancer - Liver

• Registration Number: ACTRN12618000232235
• Lead Sponsor: Concord Cancer Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-02-13
• Study Completion: 2019-04-16
• Last Update Posted: 26 August 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients developing neurotoxicity > Grade 2 following their chemotherapy cycle as measured by the oxaliplatin-specific neurotoxicity scale (OSNS) modified. Compared between day 3 of cycle A vs Day 3 of cycle B.[Day 3 of chemotherapy cycles]