A Phase 2 interventional study of Starch, Potato in Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, sponsored by University of Michigan Rogel Cancer Center. Recruiting at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-04-24.
Sponsored by University of Michigan Rogel Cancer Center · Phase 2, Interventional, and Supportive care
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.
142 studies on the registry are indexed under Breast Carcinoma In Situ; 26 are open to participants now.
This study's planned enrollment of 20 is below the median of 80 across 109 interventional studies indexed under Breast Carcinoma In Situ.
Browse Breast Carcinoma In Situ studies →University of Michigan Rogel Cancer Center is the lead sponsor of 316 studies on the registry; 46 are open to participants now.
Of its 46 completed or terminated interventional studies of FDA-regulated products, 30 (65%) have results posted.
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Exclusion Criteria:
Participants receive RPS PO QD for 24 weeks in the absence of unacceptable toxicity.
Drug: Starch, Potato
Given PO
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.
Time frame: Up to 24 weeks
Incidence of adverse events
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.
Time frame: Up to 24 weeks
Relative abundance of Bifidobacteria
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.
Time frame: At baseline and 12 weeks
Proportion of patients who discontinue initially prescribed aromatase inhibitor medication due to toxicity
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.
Time frame: Up to 24 weeks
Plan to share: Yes — Participant demographics and patient-reported outcomes data will be available to researchers upon reasonable request
Supporting information: Study protocol, Sap
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University of Michigan Rogel Cancer Center