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

NCT07443943 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: UMCC 2025.125NCI-2026-00733HUM00281010
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

  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.

  Up to 24 weeks

Secondary Outcomes (3)

• Incidence of adverse events

  Up to 24 weeks

• Relative abundance of Bifidobacteria

  At baseline and 12 weeks

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

  Up to 24 weeks

Study Arms (1)

Supportive Care (RPS)

EXPERIMENTAL

Participants receive RPS PO QD for 24 weeks in the absence of unacceptable toxicity.

Drug: Starch, Potato

Interventions

Starch, Potato DRUG

Given PO

Supportive Care (RPS)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead
• The Breast Cancer Research Foundation: collaborator

Study Sites (1)

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Conditions

Breast Carcinoma In Situ

Interventions

Starch

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Polysaccharides

Study Officials

• Norah L Henry, M.D.

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cancer AnswerLine

CONTACT

1-800-865-1125; CancerAnswerLine@med.umich.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: March 2, 2026
• Study Start: April 22, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Researchers can request data once the primary analysis has been published
• Access Criteria: Deidentified data will be available to researchers upon reasonable request

Locations

US (1)