Health TrialsbyHealthPanel

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

ConditionsAnatomic Stage 0 Breast Cancer AJCC v8Anatomic Stage I Breast Cancer AJCC v8Anatomic Stage II Breast Cancer AJCC v8Anatomic Stage III Breast Cancer AJCC v8Localized Breast Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity of Michigan Rogel Cancer Center

About this 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. 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 criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Starch, Potato

    Drug

    Given PO

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Supportive Care (RPS)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to 24 weeks

Secondary outcomes

1

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.

Time frame
Up to 24 weeks
2

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.

Time frame
At baseline and 12 weeks
3

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.

Time frame
Up to 24 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Michigan Rogel Cancer Center

Lead sponsor

Breast Cancer Research Foundation

Collaborator

Source ClinicalTrials.gov
Apply now