NCT07443943 A Dietary Supplement (Resistant Potato Starch) for Reducing Musculoskeletal Symptoms in Individuals Planning to Receive Aromatase Inhibitor Therapy, AIMSS-RPS Trial
| NCT ID | NCT07443943 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Michigan Rogel Cancer Center |
| Condition | Anatomic Stage 0 Breast Cancer AJCC v8 |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-04-22 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 20 participants in total. It began in 2026-04-22 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * 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 * Aware of the nature of her diagnosis, understands study requirement, and able to sign an informed consent form Exclusion Criteria: * 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 * Known active inflammatory bowel disease * History of colectomy and/or gastric bypass * Prior AI therapy except in the context of fertility treatment * Planned use of prebiotics during study participation * Use of estrogen supplementation other than vaginal estrogen * Receipt of another investigational agent concurrent with participation in this trial
Contact & Investigator
Norah L Henry, M.D.
PRINCIPAL INVESTIGATOR
University of Michigan Rogel Cancer Center
Frequently Asked Questions
Who can join the NCT07443943 clinical trial?
This trial is open to participants of all sexes, studying Anatomic Stage 0 Breast Cancer AJCC v8. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07443943 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07443943 currently recruiting?
Yes, NCT07443943 is actively recruiting participants. Contact the research team at CancerAnswerLine@med.umich.edu for enrollment information.
Where is the NCT07443943 trial being conducted?
This trial is being conducted at Ann Arbor, United States.
Who is sponsoring the NCT07443943 clinical trial?
NCT07443943 is sponsored by University of Michigan Rogel Cancer Center. The principal investigator is Norah L Henry, M.D. at University of Michigan Rogel Cancer Center. The trial plans to enroll 20 participants.
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