Anatomic Stage 0 Breast Cancer AJCC v8Phase 2AIMSS-RPSNCT07443943
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 testing Starch, Potato in people with Anatomic Stage 0 Breast Cancer AJCC v8 and Anatomic Stage I Breast Cancer AJCC v8, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8
- What is being tested?
- Starch, Potato
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Apr 2026to Apr 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109
Cancer AnswerLine, 800-865-1125, CancerAnswerLine@med.umich.edu
Norah L. Henry, M.D.
About this study
Official title: Phase 2 Study of Aromatase Inhibitor-Associated Musculoskeletal Symptom Prevention With Resistant Potato Starch (AIMSS-RPS)
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
- Being tested
- Starch, Potato
- Medical subject headings
- Breast Carcinoma In Situ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Starch, PotatoDrug
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Supportive Care (RPS) | Experimental | Participants receive RPS PO QD for 24 weeks in the absence of unacceptable toxicity. Receives: Drug: Starch, Potato |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who took at least 70% of resistant potato starch (RPS) doses per protocol
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.
Measured: Up to 24 weeks
Secondary outcomes (3)
Incidence of adverse events
Will evaluate the frequency and severity of adverse events possibly, probably, or definitely associated with RPS. Safety and tolerability will be assessed using descriptive analysis of adverse event data (adverse events possibly, probably, or definitely associated with RPS) as well as analysis of patient-reported outcomes common terminology criteria for adverse events measures.
Measured: Up to 24 weeks
Relative abundance of Bifidobacteria
Will be assessed from stool. Sequencing data will be analyzed using standard protocols to identify butyrate generators. The primary analysis will compare relative abundance of Bifidobacteria at 12 weeks versus baseline, using Wilcoxon signed-rank tests.
Measured: At baseline and 12 weeks
Proportion of patients who discontinue initially prescribed aromatase inhibitor medication due to toxicity
Data regarding persistence with initially prescribed AI therapy will be obtained from physician notes in the electronic medical record and from patient-self report about reasons for AI discontinuation. Will estimate the proportion of participants who remain on their initially prescribed AI medication at 6 months, and report this proportion with exact 95% binomial confidence intervals. This estimate will be descriptively compared to the 86% persistence rate observed in a historical cohort.
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start22 Apr 2026
- Primary completionSep 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anatomic Stage 0 Breast Cancer AJCC v8Studies of the same condition, open and under way.
- More trials run by University of Michigan Rogel Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Breast Cancer Research Foundation
- Responsible party
- Sponsor
- Investigators
- Norah L Henry, M.D., Principal investigator, University of Michigan Rogel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07443943
- Sponsor's protocol ID
- UMCC 2025.125
- Other IDs
- NCI-2026-00733, HUM00281010
- Acronym
- AIMSS-RPS
- Status last verified
- Apr 2026
- First submitted
- 23 Feb 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participant demographics and patient-reported outcomes data will be available to researchers upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Aromatase Inhibitor-Associated Musculoskeletal Symptom Prevention With Resistant Potato Starch (AIMSS-RPS)
- ClinicalTrials.gov ID
- NCT07443943
- Acronym / sponsor ID
- AIMSS-RPS / UMCC 2025.125
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Collaborators
- Breast Cancer Research Foundation
- Study start
- 22 Apr 2026 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 2 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive Care (RPS) | Experimental | Drug: Starch, PotatoParticipants receive RPS PO QD for 24 weeks in the absence of unacceptable toxicity. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Starch, PotatoGiven PO | Drug | Supportive Care (RPS) |
Primary outcome
Proportion of patients who took at least 70% of resistant potato starch (RPS) doses per protocol
Time frame: Up to 24 weeks
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.
3 secondary outcomes
Incidence of adverse events
Time frame: Up to 24 weeks
Relative abundance of Bifidobacteria
Time frame: At baseline and 12 weeks
Proportion of patients who discontinue initially prescribed aromatase inhibitor medication due to toxicity
Time frame: Up to 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Individual participant dataSharing planned: Yes. Participant demographics and patient-reported outcomes data will be available to researchers upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Norah L Henry, M.D. principal investigator
University of Michigan Rogel Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Starch, Potato in people with Anatomic Stage 0 Breast Cancer AJCC v8 and Anatomic Stage I Breast Cancer AJCC v8, run by University of Michigan Rogel Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cancer AnswerLine (1-800-865-1125, CancerAnswerLine@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.