Resistant potato starch to reduce joint and muscle symptoms in people starting aromatase inhibitors for early-stage or high-risk breast cancer
Phase 2 Study of Aromatase Inhibitor-Associated Musculoskeletal Symptom Prevention With Resistant Potato Starch (AIMSS-RPS)
This phase II trial will test whether taking resistant potato starch can reduce joint pain and stiffness in people with stage 0–III or high-risk breast cancer who are starting aromatase inhibitor therapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Sex | All |
| Sponsor | University of Michigan Rogel Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT07443943 on ClinicalTrials.gov |
What this trial studies
This single-site phase II interventional trial will give participants an oral resistant potato starch supplement around the time they begin standard aromatase inhibitor (AI) therapy and follow them for at least 24 weeks. The rationale is that reduced levels of beneficial gut bacteria have been linked to AI-associated musculoskeletal symptoms, and resistant potato starch is a prebiotic that may promote growth of those bacteria. The trial will monitor musculoskeletal symptoms, safety, and tolerability while participants receive AI therapy. Participants are adults planning to start AI therapy for prevention or treatment of early-stage breast cancer and must be able to take oral medication and consent in English.
Who should consider this trial
Good fit: Ideal candidates are people with stage 0–III breast cancer or at high risk of breast cancer who are planning to start at least 24 weeks of standard aromatase inhibitor therapy, can take oral medication, and can read and consent in English.
Not a fit: People with distant metastatic breast cancer, those who are pregnant or breastfeeding, or those planning to receive concurrent chemotherapy, immunotherapy, or abemaciclib (all excluded) are unlikely to participate or derive benefit from this protocol.
Why it matters
Potential benefit: If successful, this could reduce joint pain and stiffness and help people remain on aromatase inhibitor treatment.
How similar studies have performed: Early research has linked the gut microbiome to aromatase inhibitor–related joint symptoms, but using resistant potato starch for this purpose is a relatively novel approach without broad proven clinical success to date.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ann Arbor, Michigan
- University of Michigan Rogel Cancer Center — Ann Arbor, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Norah L Henry, M.D. — University of Michigan Rogel Cancer Center
- Study coordinator: Cancer AnswerLine
- Email: CancerAnswerLine@med.umich.edu
- Phone: 1-800-865-1125
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.