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Идёт набор NCT07443943

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

Фаза II С лечением 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

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Starch, Potato.
Кому может быть актуально
Состояния в реестре: 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. Базовые параметры: Без ограничений · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

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

Обзор

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.

Вмешательства

  • Препарат Starch, Potato
    Given PO

Первичные конечные точки

  • Proportion of patients who took at least 70% of resistant potato starch (RPS) doses per protocol [Срок оценки: Up to 24 weeks]
Вторичные конечные точки (3)
  • Incidence of adverse events [Срок оценки: Up to 24 weeks]
  • Relative abundance of Bifidobacteria [Срок оценки: At baseline and 12 weeks]
  • Proportion of patients who discontinue initially prescribed aromatase inhibitor medication due to toxicity [Срок оценки: Up to 24 weeks]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

США · 1 центр
  • University of Michigan Rogel Cancer Center — Ann Arbor

Идентификаторы

NCT: NCT07443943 · UMCC 2025.125 · NCI-2026-00733 · HUM00281010

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗