NCT07443943RecruitingPhase 2
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)
Source: ClinicalTrials.gov · Last updated 24 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 23 Feb 2026
- Start date
- 22 Apr 2026
- Primary completion date
- Sept 2027
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Diseases
- Childhood cancers
- NCT number
- NCT07443943
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 20
- From 22 Apr 2026 to the primary completion date, Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current or planned use of chemotherapy or immunotherapy during study participation
- Prior AI therapy except in the context of fertility treatment
- Receipt of another investigational agent concurrent with participation in this trial
Other illness
- Distant metastatic breast cancer
- Known active inflammatory bowel disease
- History of colectomy and/or gastric bypass
Other
- Current or planned use of abemaciclib during study participation
- Pregnant or breast feeding, or planning to become pregnant during study participation
- Planned use of prebiotics during study participation
- Use of estrogen supplementation other than vaginal estrogen
Who the study is looking for
- 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
Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Michigan Rogel Cancer Center Coordinator of this site? Confirm its status | Ann Arbor | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.