RightFit
RecruitingPhase 2

A Dietary Supplement (Resistant Potato Starch) for Reducing Musculoskeletal Symptoms in Individuals Planning to Receive Aromatase Inhibitor Therapy, AIMSS-RPS Trial

Phase 2 Study of Aromatase Inhibitor-Associated Musculoskeletal Symptom Prevention With Resistant Potato Starch (AIMSS-RPS)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
No age limits stated
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether resistant potato starch, a dietary supplement, is safe and can reduce joint pain, stiffness, and other bone and muscle symptoms. It is for people with stage 0–III breast cancer or a high risk of breast cancer who plan to start an aromatase inhibitor, a drug used to treat or prevent breast cancer.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Plan to start an aromatase inhibitor for stage 0–III breast cancer or high breast cancer risk and take it for at least 24 weeks.
  • Have average joint pain of 0–6 on a 0–10 scale during the 7 days before joining.
  • Can take medicine by mouth.
  • Can read and understand English.
  • Understand your diagnosis and the study requirements, and can sign a form agreeing to join.

Who can't join

  • Have breast cancer that has spread to distant parts of the body.
  • Use or plan to use abemaciclib, chemotherapy, or immunotherapy during the study.
  • Are pregnant, breastfeeding, or planning to become pregnant during the study.
  • Have active inflammatory bowel disease, which causes swelling in the gut.
  • Have had surgery to remove part or all of the colon, or gastric bypass surgery.
  • Have taken an aromatase inhibitor before, unless it was for fertility treatment.
  • Plan to use prebiotics, products that feed gut bacteria, or use estrogen supplements other than vaginal estrogen.
  • Receive another experimental treatment during the study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (1)

MI