Nurturing Exercise Routine for Greater Improvement in Zest and Energy on Enhertu

Официальное название

ENERGIZE: Engagement With a Nurturing Exercise Routine for Greater Improvement in Zest and Energy on Enhertu: A Single-Center Pilot Study

Обзор

The goal of this study is to test the efficacy of using a 12-week, home-based, unsupervised aerobic and resistance training exercise program for changes in cancer-related fatigue in patients with metastatic breast cancer who are receiving Enhertu.

Вмешательства

• Другое Whole-body resistance training and aerobic exercise
  A 12-week individualized, home-based, unsupervised, whole-body resistance training and aerobic exercise routine will be provided to each study participant.

Первичные конечные точки

• Change in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue score from baseline to Week 13 (end of exercise intervention). [Срок оценки: 13 weeks]

Вторичные конечные точки (2)

• Feasibility defined as greater than 75% of all participants completing greater than 66% of all prescribed workouts from baseline to Week 13. [Срок оценки: 13 weeks]
• Mean Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue score measured every three weeks from baseline to Week 13. [Срок оценки: 13 weeks]

Критерии участия

Критерии включения

• Subject aged ≥ 18 years
• Diagnosis of locally advanced/unresectable or metastatic breast cancer. Note: Patients with High-Risk HER-2 + breast cancer after completion of neoadjuvant chemotherapy requiring adjuvant Enhertu are allowed at the discretion of the treating physician.
• Has received 3 or 4 cycles of Enhertu and is expected to continue treatment for at least 12 weeks. Note: HER-2 targeted systemic therapy (e.g. Trastuzumab and/or Pertuzumab) in conjunction with Enhertu is allowed.
• Able and willing to participate in the interventional aerobic exercise and resistance exercises.
• Currently following standard of care contraception requirements and willing to continue following these requirements for the duration of therapy.
• Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
• Experiencing clinical fatigue symptoms in the opinion of the investigator.
• Subject has completed the ACSM exercise preparticipation health screening and is, in the opinion of the investigator, fit to participate in this study.

Критерии исключения

-Currently adhering to national physical activity guidelines for resistance training, as defined as participating in structured resistance training ≥ two days per week.

• Structured is defined as time set aside in the subject's day to workout.
• Resistance training is defined as exercises which use weights, bands, or body weight (e.g., squats or push-ups).

AND Currently participating in structured moderate-intensity aerobic exercise for ≥ 150 minutes per week.

• Moderate-intensity exercise is defined as activities where the subject can talk but not sing.
• Aerobic exercise includes, but is not limited to, walking, swimming, cycling, running, rowing, hiking, and elliptical.

• Medical, psychiatric, cognitive, or other conditions that may compromise the participant's ability to understand the participant information, give informed consent, comply with the study protocol or complete the study.
• Participants taking prohibited medications as described in Section 6.4.1.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Huntsman Cancer Institute at University of Utah — Salt Lake City

Идентификаторы

NCT: NCT07203378 · HCI194215

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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