High-Intensity Exercise and High-Fiber Diet for Immunotherapy Outcomes in Melanoma Patients: The DUO Trial

Официальное название

Modulating Immune-Microbiome Axis Through High-Intensity Exercise and High-Fiber Diet for Immunotherapy Outcomes in Melanoma Patients: The DUO Trial

Обзор

The purpose of this study is to determine whether high-intensity exercise and high-fiber diet are feasible and improve various health outcomes among participants with advanced melanoma receiving immunotherapy. The names of the groups in this research study are: * High-Intensity Exercise (EX) * High-fiber Diet (DT) * Combined High-Intensity Exercise and High-Fiber Diet (COMB) * Attention Control (AC)

Подробное описание

This single-center, four-arm, pilot randomized research study is to test if high-intensity exercise and high-fiber diet are feasible and effective in improving the gut microbiome health, immune function, physical fitness, treatment-related side effects, and treatment outcomes in participants with advanced melanoma receiving immunotherapy. Participants will be randomized into 1 of 4 study groups: Group A Exercise, Group B Diet, Group C Combined, and Group D Attention Control. Randomization means a participant will be placed into an intervention group by chance.

The information learned by doing this research may help determine whether participating in such lifestyle interventions are tolerable during immunotherapy and exert health benefits among melanoma participants.

The research study procedures include screening for eligibility, study visits, stool samples, blood tests, and questionnaires.

Participation in this study is expected to last up to a total of 9 weeks.

It is expected about 40 people will take part in this research study.

This study is sponsored by the World Cancer Research Fund International and American Association for Cancer Research.

Вмешательства

• Поведенческое Exercise Program
  A high-intensity interval training, aerobic exercise program virtually supervised, home-based, and appointment-based program under direct one-on-one supervision by a trained oncology exercise specialist. Sessions will be conducted via the Zoom platform. Participants will be provided with home stationary bike, heart rate monitor, blood pressure monitor. For participants who do not have a smart device, a Wi-Fi enabled tablet will be provided.
• Поведенческое Diet Program
  A virtual dietary consultation program supervised by trained research staff. Appointments will be conducted via the Zoom platform. Participants will receive an education handout at the baseline visit.

Первичные конечные точки

• Proportion of Participants Completing the Intervention Sessions [Срок оценки: Post-intervention (Week 10)]

Вторичные конечные точки (12)

• Change in Gut Microbiome Diversity [Срок оценки: Baseline (Week 1) and post-intervention (Week 10)]
• Change in Systemic Immune Function [Срок оценки: Baseline (Week 1) and post-intervention (Week 10)]
• Change in Cardiopulmonary Fitness [Срок оценки: Baseline (Week 1) and post-intervention (Week 10)]
• Change in Short Physical Performance Battery (SPPB) [Срок оценки: Baseline (Week 1) and post-intervention (Week 10)]
• Change in Percent Body Fat [Срок оценки: Baseline (Week 1) and post-intervention (Week 10)]
• Change in Lean mass [Срок оценки: Baseline (Week 1) and post-intervention (Week 10)]
• Change in Hip circumference [Срок оценки: Baseline (Week 1) and post-intervention (Week 10)]
• Change in Waist circumference [Срок оценки: Baseline (Week 1) and post-intervention (Week 10)]
• Change in Health-Related Quality of life (EORTC-QLQ C30) [Срок оценки: Baseline (Week 1) and post-intervention (Week 10)]
• Change in MDASI-Immunotherapy Questionnaire Score [Срок оценки: Baseline (Week 1) and post-intervention (Week 10)]
• Change in Anxiety (HADS) [Срок оценки: Baseline (Week 1) and post-intervention (Week 10)]
• Change in Depression (HADS) [Срок оценки: Baseline (Week 1) and post-intervention (Week 10)]

Критерии участия

Критерии включения

• Age ≥18 years.
• Histologically diagnosed with melanoma.
• Having been or newly receiving immunotherapy for at least one month.
• Having a plan to continue immunotherapy for at least 8 weeks at the time of recruitment.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2, indicating the ability to fulfill physical fitness and function assessments.
• Ability to understand and willingness to provide informed consent.

Критерии исключения

• Participating in ≥ 150 minutes of moderate-to-vigorous aerobic exercise per week over the past month.
• Consuming ≥ 30 grams/day of dietary fiber over the past month.
• 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 cannot 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

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 2 центра

• Dana-Farber Cancer Institute — Boston
• Fred Hutch/University of Washington Cancer Consortium — Seattle

Идентификаторы

NCT: NCT06298734 · RG1125274 · 20845 · NCI-2024-02279

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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