Exercise for Tumor Suppressive Impact in Men With Prostate Cancer at High-Risk of Progression on Active Surveillance: The REMOVE Trial

Обзор

The purpose of this study is to determine whether a 12-week, home-based, virtually supervised exercise program will slow cancer progression of prostate cancer among men with prostate cancer at high-risk of progression undergoing active surveillance. The name of the study intervention involved in this study is: Aerobic high-intensity interval training (HIIT) (training exercise intervention)

Подробное описание

This research study is a randomized controlled study for a home-based, virtually supervised, aerobic exercise intervention for men with prostate cancer at high-risk of progression undergoing active surveillance. There is evidence that exercise may suppress cancer progression, but the evidence is preliminary.

Participants will be randomized into one of two treatment groups: Group A: Aerobic high-intensity interval training (HIIT) versus Group B: Waitlist Control. Randomization means a participant is placed into a study group by chance.

The research study procedures include screening for eligibility, study treatment visits, survey questionnaires, blood tests, and follow-up visits.

Participation in this research study is expected to last about 14 weeks.

It is expected that about 68 people will take part in this research study.

The Prostate Cancer Foundation is providing funding for this research study.

Вмешательства

• Поведенческое High-Intensity Interval Training Exercise Program
  Home-based, virtually supervised, aerobic exercise program of 36 sessions accessible via internet-enabled tablet (provided to participant if needed). Participants will be supplied with stationary bike, heart rate monitor, and blood pressure monitor.
• Поведенческое High-Intensity Interval Training Exercise Program
  (Optionally) Home-based, virtually supervised, aerobic exercise program of 36 sessions accessible via internet-enabled tablet (provided to participant if needed). Participants will be supplied with stationary bike, heart rate monitor, and blood pressure monitor.

Первичные конечные точки

• Prostate-Specific Antigen (PSA) Level [Срок оценки: Baseline (Week 1) and post-intervention (Week 14)]

Вторичные конечные точки (12)

• Prostate-Specific Antigen (PSA) Velocity [Срок оценки: Baseline (Week 1) and post-intervention (Week 14)]
• Prostate-Specific Antigen (PSA) Doubling Time [Срок оценки: Baseline (Week 1) and post-intervention (Week 14)]
• Proliferation of LNCaP Prostate Cancer Cell Line [Срок оценки: Baseline (Week 1) and post-intervention (Week 14)]
• Cardiorespiratory Fitness [Срок оценки: Baseline (Week 1) and post-intervention (Week 14)]
• Muscular Strength [Срок оценки: Baseline (Week 1) and post-intervention (Week 14)]
• Short Physical Performance Battery (SPPB) [Срок оценки: Baseline (Week 1) and post-intervention (Week 14)]
• Health-Related Quality of Life [Срок оценки: Baseline (Week 1) and post-intervention (Week 14)]
• Prostate Cancer-Specific Anxiety [Срок оценки: Baseline (Week 1) and post-intervention (Week 14)]
• Fear of Cancer Progression Assessment [Срок оценки: Baseline (Week 1) and post-intervention (Week 14)]
• Sleep Quality [Срок оценки: Baseline (Week 1) and post-intervention (Week 14)]
• Body Composition [Срок оценки: Baseline (Week 1) and post-intervention (Week 14)]
• Prostate Cancer Symptoms [Срок оценки: Baseline (Week 1) and post-intervention (Week 14)]

Критерии участия

Критерии включения

• Age ≥18 years.
• Histologically diagnosed with localized prostate cancer.
• Initiating or undergoing active surveillance.
• Having a higher risk of progression, defined as meeting one or more of the following: (1) favorable- intermediate risk prostate tumor at diagnosis, (2) obesity (body mass index ≥ 30), and/or (3) self- identified as Black or African American.
• No plans for invasive treatment for their prostate cancer in the 12 weeks following the time of enrollment.
• Ability to understand and willingness to provide informed consent.

Критерии исключения

• Received any invasive curative-intent treatment for prostate cancer, including surgery, chemotherapy, radiation therapy, and hormonal therapy.
• Patients with metastasis and/or other active malignancies (except basal cell carcinoma) and/or receiving treatment for those malignancies.
• Participating in any (>0 min/week) high-intensity exercise at the time of recruitment.
• Having chronic medical conditions that are clinically unstable or uncontrolled with medications, deemed high-risk for exercise. These include but are not limited to unstable cardiac diseases, uncontrolled diabetes, and bone metastases with imminent risk of fracture.
• Having a high risk for noncompliance with study procedures. This will be determined by the study team based on the history of missed oncology appointments (i.e., ≥3 no-shows in 6 months) and poor responsiveness during recruitment (i.e., ≥3 unreturned contacts).
• Patients who are non-English speaking and unable to complete the participant surveys.

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

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 4 центра

• Beth Israel Deaconess Medical Center — Boston
• Brigham and Women's Hospital — Boston
• Dana-Farber Cancer Institute — Boston
• Fred Hutch/University of Washington Cancer Consortium — Seattle

Идентификаторы

NCT: NCT05918263 · RG1125288 · 20857 · NCI-2023-07008

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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