Resistance Exercise Combined With Protein Supplementation in People With Pancreatic Cancer: The RE-BUILD Trial

Официальное название

Resistance Exercise Combined With Protein Supplementation for Skeletal Muscle Mass in People With Pancreatic Cancer Undergoing Chemotherapy: The RE-BUILD Trial

Обзор

The purpose of this research is to determine whether a virtually supervised resistance exercise (RE) intervention combined with protein supplementation (PS) is feasible in pancreatic cancer patients initiating chemotherapy and if it will improve skeletal muscle mass. The names of the study interventions involved in this study are: * Resistance training and protein supplement intake (RE + PS) * Resistance training (RE) * Attention control (AC), home-based stretching

Подробное описание

This research study is a randomized controlled trial that will assess feasibility and compare skeletal muscle mass, biomarkers of tissue wasting, physical function, and overall quality of life between three groups - exercise and supplement, exercise-only, and attention control. This study intends to evaluate whether resistance exercise and protein supplementation can improve skeletal muscle mass as well as decrease tissue wasting biomarkers in the blood, among patients undergoing chemotherapy for pancreatic cancer as there is some evidence that pancreatic cancer patients can experience muscle wasting while on chemotherapy.

The research study procedures include: screening for eligibility and study treatment including extensive evaluations of participant fitness and body composition including CT, blood tests, fitness and strength assessments, and surveys at study entry, half-way through the intervention, and follow-up visit.

Participants in this study will be randomly assigned to one of three groups: 1) Resistance exercise and protein supplementation (RE+ PS), 2) Resistance exercise (RE), or 3) Attention control (AC).

This research study is expected to last for up to a total of 4 months.

It is expected that about 45 people will take part in this research study.

Вмешательства

• Поведенческое Resistance Training (RT) and Protein Supplementation (PS)
  Aerobic and resistance exercise with orally consumed pre-packed protein supplement
• Поведенческое Resistance Training (RT)
  Aerobic and resistance exercise
• Поведенческое Attention Control (AC
  Stretching

Первичные конечные точки

• Exercise Session Attendance Rate [Срок оценки: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)]
• Protein Supplementation (PS) Rate [Срок оценки: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)]

Вторичные конечные точки (12)

• Skeletal Muscle Mass Change [Срок оценки: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)]
• Tissue Wasting Biomarker Change [Срок оценки: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)]
• Physical function - Margaria Stair Climb [Срок оценки: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)]
• Muscular Strength [Срок оценки: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)]
• Physical Fitness - Performance [Срок оценки: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)]
• Physical Fitness - Sit to Stand [Срок оценки: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)]
• Gait Speed [Срок оценки: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)]
• Physical Function - Handgrip Strength [Срок оценки: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)]
• Physical Function - 6 minute walk test [Срок оценки: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)]
• Psychosocial function - Fatigue [Срок оценки: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)]
• Psychosocial function - Quality of Life [Срок оценки: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)]
• Psychosocial function - Depression [Срок оценки: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)]

Критерии участия

Критерии включения

• Non-metastatic pancreatic cancer patients initiating neoadjuvant chemotherapy.
• Ability to understand and the willingness to sign a written informed consent document.
• Over the age of 18 years; children under the age of 18 will be excluded due to rarity of disease.
• Speak English or Spanish.
• Able to provide physician clearance to participate in the exercise program.
• Able to initiate a supervised exercise program (free from any cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity).
• Currently participate in less than or equal to 60 minutes of structured moderate or vigorous exercise/week.
• Does not smoke (no smoking during previous 12 months).
• Willing to travel to DFCI for assessments.

Критерии исключения

• Patients should not have any uncontrolled illness including ongoing or active infection, uncontrolled diabetes, hypertension or thyroid disease.
• Patients may not be receiving any other investigational agents.
• Patients with other active malignancies are ineligible for this study.
• Patients with metastatic disease.
• History of any musculoskeletal, cardiorespiratory or neurological diseases that preclude the participation in exercise.
• Patients expected to receive other cancer directed treatments during the study and assessment period.
• Participates in more than 60 minutes of structured moderate or vigorous exercise/week.
• Currently smokes.
• Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.
• Is unable to travel to DFCI for assessments.
• Patients who are pregnant due to the unknown effects of exercise on the developing fetus.

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

Скрининг

Центры проведения

США · 1 центр

• Dana Farber Cancer Institute — Boston

Идентификаторы

NCT: NCT05356117 · 21-506

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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