Actively Recruiting
A Dietary Supplement (Resistant Potato Starch) for Reducing Musculoskeletal Symptoms in Individuals Planning to Receive Aromatase Inhibitor Therapy, AIMSS-RPS Trial
Led by University of Michigan Rogel Cancer Center · Updated on 2026-04-24
20
Participants Needed
1
Research Sites
101 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
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
Official 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...
- Planning to start standard aromatase inhibitor therapy for at least 24 weeks for stage 0-III breast cancer or high breast cancer risk
- Average joint pain of 0-6 on a 0-10 scale in the 7 days before enrollment
- Able to take oral medication
- Able to read and understand English
- Understands diagnosis and study requirements 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 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
- Previous aromatase inhibitor therapy except for fertility treatment
- Planned use of prebiotics during the study
- Use of estrogen supplements other than vaginal estrogen
- Participation in another investigational agent trial concurrently
AI-Screening
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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
CONTACT
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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