Metamucil for Investigator-Initiated Clinical Trial in Oncology Supportive Care

I am writing to you on behalf of the clinical research team at Fox Chase Cancer Center to explore the product donation or subsidy of Metamucil by Procter & Gamble to support our upcoming investigator-initiated clinical trial. Our study focuses on providing critical supportive care for cancer patients receiving tyrosine kinase inhibitors (TKIs), a population that frequently suffers from debilitating gastrointestinal toxicities.

While TKIs have revolutionized targeted cancer therapy, severe diarrhea and bowel irregularity remain a primary cause of decreased quality of life, dose reductions, and treatment discontinuation in this patient population. Soluble psyllium fiber—the active ingredient in Metamucil—presents a highly promising, safe, and non-pharmacologic intervention. By absorbing excess fluid and adding bulk to the stool, we hypothesize that Metamucil will significantly reduce the severity of TKI-induced GI events, allowing patients to maintain their quality of life and remain on their life-saving oncology regimens. We have retrospectively analyzed the onset of diarrhea in our of own TKI clinical trials, and the data suggests clinical benefit. We are happy to share these insights at your request.

Here is a brief overview of the planned study: • Study Title: STOP the TIDE: Steady Oral Psyllium for TKI-induced Diarrheal Events • Primary Objective: To evaluate the efficacy of daily Metamucil supplementation in reducing the frequency and severity of TKI-associated diarrhea in cancer patients • Target Enrollment: 35 patients • Study Duration: 12 weeks of active intervention per patient; expected total study duration of 18-36 months. • Current Status: Final protocol modification • Extensive multi-disciplinary involvement: Our dedicated team includes a respected academic medical oncologist who has published numerous peer-reviewed scientific papers, an aspiring academic medical oncologist, a senior clinical research nurse committed to supporting quality of life for cancer patients, and a hardworking research support team.