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

20 Participants
are divided into 1 treatment group

Locations

1
University of Michigan Rogel Cancer Center48109, Ann ArborMichigan, United States

Sponsors and collaborators

University of Michigan Rogel Cancer Center

Lead sponsor

Breast Cancer Research Foundation

Collaborator