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Phase 2 Study of Aromatase inhibitor-associated musculoskeletal symptom Prevention with Resistant Potato Starch (AIMSS-RPS)

Primary Investigator
Henry, Lynn
Status
OPEN TO ACCRUAL
Phase
II
NCT Number
NCT07443943
UM Number
2025.125
Age Group
Adults
Management Group
CTSU - Oncology
Oncology Group
Breast Oncology
ID (Protocol)
63535
Secondary Protocol No
HUM00281010
Scope
Unspecified
Sponsor Type
National
Disease Site
Breast
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.

Eligibility: 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