Recruiting
Phase 2

Resistant Potato Starch with Aromatase Inhibitor

Sponsor:

University of Michigan Rogel Cancer Center

Code:

NCT07443943

Conditions

Anatomic Stage 0 Breast Cancer AJCC v8

Anatomic Stage I Breast Cancer AJCC v8

Anatomic Stage II Breast Cancer AJCC v8

Anatomic Stage III Breast Cancer AJCC v8

Localized Breast Carcinoma

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

Starch, Potato

Study Details

Brief summary:

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

Anatomic Stage 0 Breast Cancer AJCC v8

Anatomic Stage I Breast Cancer AJCC v8

Anatomic Stage II Breast Cancer AJCC v8

Anatomic Stage III Breast Cancer AJCC v8

Localized Breast Carcinoma

Study ID

NCT07443943

Start date

Apr 22, 2026

Status verified date

Apr, 2026

Completion date

Apr, 2028

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Supportive Care (RPS)

Participants receive RPS PO QD for 24 weeks in the absence of unacceptable toxicity.

Interventions

Starch, Potato

Given PO

Primary outcome measure

  • Proportion of patients who took at least 70% of resistant potato starch (RPS) doses per protocol [ Time Frame: Up to 24 weeks ]

Central Contacts and Locations

Central contacts

Cancer AnswerLine

1-800-865-1125CancerAnswerLine@med.umich.edu

Locations

University of Michigan Rogel Cancer Center

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Cancer AnswerLine

800-865-1125CancerAnswerLine@med.umich.edu

Principal Investigator:

Norah L. Henry, M.D.

More Information

Sponsor

University of Michigan Rogel Cancer Center

Last update posted

Apr 24, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Michigan Rogel Cancer Center on 2026-04-24.