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Phase 2 Study of Aromatase Inhibitor-Associated Musculoskeletal Symptom Prevention With Resistant Potato Starch (AIMSS-RPS)
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.
Age
All ages
Sex
ALL
Healthy Volunteers
Yes
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States
Start Date
March 1, 2026
Primary Completion Date
August 1, 2027
Completion Date
March 1, 2028
Last Updated
March 2, 2026
20
ESTIMATED participants
Starch, Potato
DRUG
Lead Sponsor
University of Michigan Rogel Cancer Center
Collaborators
NCT06401889
NCT06999798
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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