A Dietary Supplement (Resistant Potato Starch) for Reducing Musculoskeletal Symptoms in Individuals Planning to Receive Aromatase Inhibitor Therapy, AIMSS-RPS Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Starch, Potato.
- Who it may be relevant to
- Registry 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. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Phase 2 Study of Aromatase Inhibitor-Associated Musculoskeletal Symptom Prevention With Resistant Potato Starch (AIMSS-RPS)
Overview
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.
Interventions
- Drug Starch, Potato
Given PO
Primary outcome measures
- Proportion of patients who took at least 70% of resistant potato starch (RPS) doses per protocol [Time frame: Up to 24 weeks]
Secondary outcome measures (3)
- Incidence of adverse events [Time frame: Up to 24 weeks]
- Relative abundance of Bifidobacteria [Time frame: At baseline and 12 weeks]
- Proportion of patients who discontinue initially prescribed aromatase inhibitor medication due to toxicity [Time frame: Up to 24 weeks]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- University of Michigan Rogel Cancer Center — Ann Arbor
Identifiers
NCT: NCT07443943 · UMCC 2025.125 · NCI-2026-00733 · HUM00281010