← Back to Search

Mesalamine for Colitis Prevention During Cancer Treatment (IMPACT 1 Trial)

Phase 2

Waitlist Available

Research Sponsored by AHS Cancer Control Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up ir-aes that are greater than grade 2 (incidence and severity, as well as causality) will be assessed at each screening, cycle 1-4 (each cycle is 3 weeks) and throughout the post treatment follow-up (12, 18 and 24 weeks)

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if a medicine can lower the chance and seriousness of diarrhea caused by cancer treatment.

Who is the study for?

Adults with advanced melanoma who can consent to treatment, are not pregnant or breastfeeding, agree to use effective birth control, and have no severe health issues that could interfere with the trial. They must have a certain level of blood cells and organ function.

What is being tested?

The trial is testing if mesalamine can prevent or lessen diarrhea caused by ipi/nivo therapy in melanoma patients. It's seeing whether taking mesalamine before starting cancer treatment makes a difference.

What are the potential side effects?

While specific side effects for this study aren't listed, mesalamine generally may cause stomach pain, headache, nausea, vomiting, fever; ipi/nivo might cause immune-related issues like rash or colitis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ ir-aes that are greater than grade 2 (incidence and severity, as well as causality) will be assessed at each screening, cycle 1-4 (each cycle is 3 weeks) and throughout the post treatment follow-up (12, 18 and 24 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~ir-aes that are greater than grade 2 (incidence and severity, as well as causality) will be assessed at each screening, cycle 1-4 (each cycle is 3 weeks) and throughout the post treatment follow-up (12, 18 and 24 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and ir-aes that are greater than grade 2 (incidence and severity, as well as causality) will be assessed at each screening, cycle 1-4 (each cycle is 3 weeks) and throughout the post treatment follow-up (12, 18 and 24 weeks) for reporting.