Actively Recruiting
Phase 2 Study of Resistant Potato Starch to Prevent Aromatase Inhibitor-Associated Musculoskeletal Symptoms in Breast Cancer (AIMSS-RPS)
Led by University of Michigan Rogel Cancer Center · Updated on 2026-04-24
20
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
Sponsors
U
University of Michigan Rogel Cancer Center
Lead Sponsor
B
Breast Cancer Research Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a dietary supplement called resistant potato starch to see if it can reduce musculoskeletal symptoms in patients with stage 0-III breast cancer or those at high risk for breast cancer who are starting treatment with an aromatase inhibitor. Aromatase inhibitors are drugs used for breast cancer treatment or prevention, but many patients experience bone and muscle symptoms like joint pain or stiffness. This study explores whether resistant potato starch, which may help grow beneficial gut bacteria, can lessen these side effects. Participants will take resistant potato starch by mouth once daily for 24 weeks, unless unacceptable side effects occur. This is a phase II trial focusing on the safety and effectiveness of this dietary supplement alongside aromatase inhibitor therapy. The study allows some additional medications like gonadotropin-releasing hormone antagonists and certain cancer therapies during participation. During the trial, researchers will monitor how well participants follow the supplement regimen, check for side effects, and analyze changes in gut bacteria levels at baseline and after 12 weeks. They will also track if participants stop aromatase inhibitor treatment due to toxicity. The total study duration for each participant is up to 24 weeks, with ongoing assessments throughout this period to understand the supplement's impact on musculoskeletal symptoms.
CONDITIONS
Brief Title
A Dietary Supplement (Resistant Potato Starch) for Reducing Musculoskeletal Symptoms in Individuals Planning to Receive Aromatase Inhibitor Therapy, AIMSS-RPS Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient planning to start aromatase inhibitor therapy and receive treatment for at least 24 weeks
- Stage 0 to III breast cancer or high risk of developing breast cancer
- Average joint pain 0 to 6 on a 0 to 10 scale in the 7 days before enrollment
- Able to take oral medication
- Able to read and understand English
- Aware of diagnosis, understands study, and can sign informed consent
You will not qualify if you...
- Distant metastatic breast cancer
- Current or planned use of abemaciclib during the study
- Current or planned use of chemotherapy or immunotherapy during the study
- Pregnant, breastfeeding, or planning pregnancy during the study
- Known active inflammatory bowel disease
- History of colectomy or gastric bypass surgery
- Prior aromatase inhibitor therapy except for fertility treatment
- Planned use of prebiotics during the study
- Use of estrogen supplements other than vaginal estrogen
- Receiving another investigational agent during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 weeks
Participants take resistant potato starch orally once daily to support reduction of musculoskeletal symptoms while receiving aromatase inhibitor therapy.
Visits occur at baseline and 12 weeks for assessments; additional visits may occur as needed during treatment
Trial Site Locations
Total: 1 location
1
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
Research Team
C
Cancer AnswerLine
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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