Resistant potato starch to reduce joint and muscle symptoms in people starting aromatase inhibitors for early-stage or high-risk breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Navigation program to boost survivorship support participation for non-metastatic breast cancer survivors

  This program tests whether a patient navigation service helps non-metastatic breast cancer survivors use survivorship support services more often.

  Recruiting Ohio State University Comprehensive Cancer Center · Columbus, Ohio · NCT07699991

• 5-strain probiotic to prevent bone loss during aromatase inhibitor therapy

  This trial will try a 5-strain probiotic called WBF-038 to see if it prevents bone loss in people with early-stage hormone receptor–positive breast cancer who are starting aromatase inhibitor therapy.

  Recruiting Phase 2 Mayo Clinic · Jacksonville, Florida · NCT07044310

• Improving skin quality and self-esteem in breast cancer survivors on hormone therapy

  This study is testing how hormone therapy affects skin quality and self-esteem in breast cancer survivors, while also offering skincare advice to see if it helps them feel better about themselves.

  Recruiting Mayo Clinic · Jacksonville, Florida · NCT06401889

• Blended e-Health Program to Help Women with Breast or Gynecologic Cancer Manage Fear of Cancer Progression

  This trial tests a blended online and group program to see if it helps women with breast or gynecologic cancer feel less fear that their cancer could grow or spread.

  Recruiting at 11 sites City of Hope Medical Center · Arcadia, California and 10 other locations · NCT07741968

• Personalized Exercise Plan for Breast Cancer Survivors on Chemotherapy

  This trial tests whether adding a guided exercise program to a healthy-lifestyle education plan helps breast cancer patients undergoing chemotherapy maintain fitness, heart health, and quality of life.

  Recruiting at 3 sites Wake Forest University Health Sciences · Winston-Salem, North Carolina and 3 other locations · NCT07474090

• Goserelin Injections: Is Upper-Gluteal Dosing as Good as Abdominal Dosing for OFS in Localized and Locally Advanced HR+ Breast Cancer

  This phase 2 trial tests whether giving goserelin acetate injections in the upper gluteal region works as well as abdominal injections for suppressing ovarian function in premenopausal women with localized or locally advanced hormone receptor–positive breast cancer.

  Recruiting Phase 2 Mayo Clinic · Rochester, Minnesota · NCT07460752

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.