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RecruitingAccepts healthy volunteersPhase 2

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

University of Michigan Rogel Cancer Center · with Breast Cancer Research Foundation · NCT07443943

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Any age listed · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Phase 2
Target enrollment
20
US sites recruiting
1
Study start
April 22, 2026
Record last updated
April 24, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Starch, Potato

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

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • University of Michigan Rogel Cancer Center

    Ann Arbor, MI 48109

    Site contact: Cancer AnswerLine · 800-865-1125 · CancerAnswerLine@med.umich.edu

Study contacts (from the official record)

  • Cancer AnswerLine · 1-800-865-1125 · CancerAnswerLine@med.umich.edu
All nutrition & metabolism studies in Michigan →
A Dietary Supplement (Resistant Potato Starch) for Reducing… (NCT07443943) | Bored Studies