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

Phase 2RecruitingNCT07443943

University of Michigan Rogel Cancer Center20 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Anatomic Stage 0 Breast Cancer AJCC v8 Anatomic Stage I Breast Cancer AJCC v8

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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

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

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

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts