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Resistant Potato Starch for Musculoskeletal Symptoms with Aromatase Inhibitor Therapy

This study is testing if a dietary supplement called resistant potato starch can help reduce muscle and bone pain (musculoskeletal symptoms) in people who are planning to take aromatase inhibitor therapy. Aromatase inhibitors are medicines used to treat or prevent breast cancer, but they can sometimes cause joint pain or stiffness. Researchers believe there might be a link between helpful gut bacteria and these symptoms. This study is for people with stage 0-III breast cancer or those at high risk for breast cancer who will be taking aromatase inhibitors for at least 24 weeks. The main goal is to see how many participants can consistently take at least 70% of the resistant potato starch doses over 24 weeks. The study is currently unclear on its recruitment status and plans to enroll 20 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment (resistant potato starch). It is a Phase II trial, and the planned enrollment is 20 participants.
What's involved
Participants will take resistant potato starch by mouth (PO) for at least 24 weeks.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at up to 24 weeks, indicating follow-up for at least that duration.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07443943

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

Recruiting
PHASE2All AgesInterventionalSupportive care
University of Michigan Rogel Cancer Center
~20 participants
Updated 2026-04-24 on ClinicalTrials.gov
What's tested:Starch, Potato

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of patients who took at least 70% of resistant potato starch (RPS) doses per protocol
Measured over Up to 24 weeks

Conditions

Anatomic Stage 0 Breast Cancer AJCC v8
Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
Localized Breast Carcinoma

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Breast Carcinoma

Where it's being run

1 sites across 1 states
Michigan1

Study leadership

  • Norah L Henry, M.D. · PRINCIPAL_INVESTIGATOR · University of Michigan Rogel Cancer Center

Who to contact

Cancer AnswerLine
[email protected]
1-800-865-1125
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Proportion of patients who took at least 70% of resistant potato starch (RPS) doses per protocolUp to 24 weeks

    Will be assessed using patient self-report. The study will be deemed feasible if at least 60% of patients take at least 70% of protocol-directed doses of RPS, as assessed on the treatment logs. Will be evaluated with a 95% confidence interval.