About this trial
This phase II trial tests the safety and effectiveness of a dietary supplement called resistant potato starch for reducing musculoskeletal symptoms in patients with stage 0-III breast cancer or who are at high risk for breast cancer and are planning to receive treatment with an aromatase inhibitor. Aromatase inhibitors are a type of drug commonly used for the treatment or prevention of breast cancer. Many people who receive aromatase inhibitors experience musculoskeletal symptoms (symptoms relating to bones and muscles, such as joint pain or stiffness). Research has shown there may be an association between reduced levels of beneficial gut bacteria and the development of aromatase inhibitor-associated musculoskeletal symptoms. Resistant potato starch is a plant-based low-digestible carbohydrate that has the potential to promote the growth of beneficial gut bacteria. Taking resistant potato starch while receiving aromatase inhibitor therapy may reduce musculoskeletal symptoms in patients with stage 0-III breast cancer or individuals at high risk of developing breast cancer.
Eligibility criteria
Qualifiers
Patient who is planning to start standard-of-care AI therapy and receive treatment for at least 24 weeks. Can be planning to take AI therapy for stage 0-3 breast cancer or because they are at high risk of developing breast cancer. Concurrent gonadotropin-releasing hormone antagonist (GnRHa) therapy, anti-osteoclast therapy, anti-HER2 therapy, ribociclib, and/or PARP inhibitor are permitted
Average joint pain 0-6 on a 0-10 scale during the 7 days prior to study enrollment
Able to take oral medication
Able to read and understand English
Disqualifiers
Distant metastatic breast cancer
Current or planned use of abemaciclib during study participation
Current or planned use of chemotherapy or immunotherapy during study participation
Pregnant or breast feeding, or planning to become pregnant during study participation
Trial design
Treatments tested in this trial
- Starch, Potato
Treatment groups
Locations
1Sponsors and collaborators
University of Michigan Rogel Cancer Center
Lead sponsor
Breast Cancer Research Foundation
Collaborator