Clinical Trials Directory

Trials / Recruiting

RecruitingNCT07443943

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

Phase 2 Study of Aromatase Inhibitor-Associated Musculoskeletal Symptom Prevention With Resistant Potato Starch (AIMSS-RPS)

Status
Recruiting
Phase
Phase 2
Study type
Interventional
Enrollment
20 (estimated)
Sponsor
University of Michigan Rogel Cancer Center · Academic / Other
Sex
All
Age
—
Healthy volunteers
Accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
DRUGStarch, PotatoGiven PO

Timeline

Start date
2026-04-30
Primary completion
2027-08-01
Completion
2028-03-01
First posted
2026-03-02
Last updated
2026-04-14

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT07443943. Inclusion in this directory is not an endorsement.