Phase 2 Study of Resistant Potato Starch to Reduce Joint and Muscle Symptoms in Patients with Stage 0-III Breast Cancer or High Risk Undergoing Aromatase Inhibitor Therapy

What this Trial Is About

Researchers are evaluating a dietary supplement called resistant potato starch to see if it can reduce musculoskeletal symptoms in patients with stage 0-III breast cancer or those at high risk for breast cancer who are starting treatment with an aromatase inhibitor. Aromatase inhibitors are drugs used for breast cancer treatment or prevention, but many patients experience bone and muscle symptoms like joint pain or stiffness. This study explores whether resistant potato starch, which may help grow beneficial gut bacteria, can lessen these side effects. Participants will take resistant potato starch by mouth once daily for 24 weeks, unless unacceptable side effects occur. This is a phase II trial focusing on the safety and effectiveness of this dietary supplement alongside aromatase inhibitor therapy. The study allows some additional medications like gonadotropin-releasing hormone antagonists and certain cancer therapies during participation. During the trial, researchers will monitor how well participants follow the supplement regimen, check for side effects, and analyze changes in gut bacteria levels at baseline and after 12 weeks. They will also track if participants stop aromatase inhibitor treatment due to toxicity. The total study duration for each participant is up to 24 weeks, with ongoing assessments throughout this period to understand the supplements impact on musculoskeletal symptoms.

A Dietary Supplement (Resistant Potato Starch) for Reducing Musculoskeletal Symptoms in Individuals Planning to Receive Aromatase Inhibitor Therapy, AIMSS-RPS Trial