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NCT07443943 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by University of Michigan Rogel Cancer Center.

Recruiting
Registry status
Phase 2
Development phase
20
Enrollment target

NCT07443943: Recruiting Phase 2 study, sponsored by University of Michigan Rogel Cancer Center.

NCT07443943 is a Phase 2 study that is actively recruiting participants, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 20 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07443943, a Phase 2 study, is actively recruiting participants, sponsored by University of Michigan Rogel Cancer Center.

RECRUITING
Registry status
Phase 2
Development phase
20 participants
Enrollment target

Study 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.

Primary Outcome

Will be assessed using patient self-report. The study will be deemed feasible if at least 60% of patients take at least 70% of protocol-directed doses of RPS, as assessed on the treatment logs. Will be evaluated with a 95% confidence interval.

Interventions

  • DRUG Starch, Potato

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2026-04-22
Est. Completion 2028-04
Phase Phase 2

What NCT07443943 shows while recruiting

NCT07443943 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower).

The record links to 0 conditions, and to 1 intervention - of which Starch, Potato is the first listed.

NCT07443943 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT07443943 about?

NCT07443943 is a clinical study titled "A Dietary Supplement (Resistant Potato Starch) for Reducing Musculoskeletal Symptoms in Individuals Planning to Receive Aromatase Inhibitor Therapy, AIMSS-RPS Trial". 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. ...

What is the current status of trial NCT07443943?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2026-04-22. Estimated completion is 2028-04.

What interventions are being tested in trial NCT07443943?

The interventions under investigation include: Starch, Potato (DRUG).

Who is sponsoring clinical trial NCT07443943?

This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT07443943's enrollment target sits among peer trials

20 1805th of 2000 higher than 107 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT07443943, the US trial registry maintained by the National Library of Medicine. NCT07443943 (small enrollment · none site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.