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NCT Number: NCT07443943

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

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.

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Key information

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 Breast Carcinoma In Situ Breast Diseases Breast Neoplasms Carcinoma Carcinoma in Situ Localized Breast Carcinoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

Location status: Recruiting

Location contact

Cancer AnswerLine

CONTACT

[email protected]

800-865-1125

Norah L. Henry, M.D.

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Starch, Potato

Drug

Given PO

Primary outcomes

  1. Proportion of patients who took at least 70% of resistant potato starch (RPS) doses per protocol

    Time frame: Up 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.

Secondary outcomes

  1. Incidence of adverse events

    Time frame: Up to 24 weeks

    Will evaluate the frequency and severity of adverse events possibly, probably, or definitely associated with RPS. Safety and tolerability will be assessed using descriptive analysis of adverse event data (adverse events possibly, probably, or definitely associated with RPS) as well as analysis of patient-reported outcomes common terminology criteria for adverse events measures.

  2. Relative abundance of Bifidobacteria

    Time frame: At baseline and 12 weeks

    Will be assessed from stool. Sequencing data will be analyzed using standard protocols to identify butyrate generators. The primary analysis will compare relative abundance of Bifidobacteria at 12 weeks versus baseline, using Wilcoxon signed-rank tests.

  3. Proportion of patients who discontinue initially prescribed aromatase inhibitor medication due to toxicity

    Time frame: Up to 24 weeks

    Data regarding persistence with initially prescribed AI therapy will be obtained from physician notes in the electronic medical record and from patient-self report about reasons for AI discontinuation. Will estimate the proportion of participants who remain on their initially prescribed AI medication at 6 months, and report this proportion with exact 95% binomial confidence intervals. This estimate will be descriptively compared to the 86% persistence rate observed in a historical cohort.

Study contacts

Contact information is provided by the study sponsor or research team.

Cancer AnswerLine

CONTACT

[email protected]

1-800-865-1125

Sponsors and collaborators

Lead sponsor

University of Michigan Rogel Cancer Center

Other

Collaborators

  • Breast Cancer Research Foundation

Registry information

Official study title

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

Acronym: AIMSS-RPS

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Mar 2, 2026
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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