Nutrition and Exercise Interventions for Androgen Deprivation Therapy-Induced Obese Frailty in Elderly and Non-Elderly Survivors of Advanced Prostate Cancer

Обзор

This trial studies how well nutrition and exercise interventions work in reducing androgen deprivation therapy-induced obese frailty in prostate cancer survivors. Individualized nutrition and exercise advice for prostate cancer patients on androgen deprivation therapy may help to reduce obese frailty and change the levels of myokines in blood.

Подробное описание

PRIMARY OBJECTIVES:

I. Assess the effect of individualized nutrition and exercise counseling interventions on myokine expression and body composition in prostate cancer (PrCa) patients being treated with androgen deprivation therapy (ADT).

SECONDARY OBJECTIVES:

I. Determine any changes in muscle strength, respiratory muscle strength and functional capacity resulting from the nutrition and exercise counseling interventions.

II. Determine any changes in myokines, circulating inflammatory and frailty-associated cytokines resulting from the nutrition and exercise counseling interventions.

III. Determine the effect of the study interventions on dietary intake, physical activity, fatigue, and quality of life.

EXPLORATORY OBJECTIVES:

I. Correlate changes in secondary objectives with prostate specific antigen (PSA) and testosterone levels.

II. Evaluate adherence to nutrition and exercise advice. III. Evaluate assessment tools and recruiting strategies.

OUTLINE:

Patients receive an individualized diet plan for 6 months. Patients complete an individualized home-based exercise program aerobic and resistance exercise over 10-30 minutes per day, at minimum 3 days per week for 6 months, and a progressive resistance exercise program including an individually tailored prescription targeting the chest, shoulders, arms, and leg musculature for 1-4 sets of 10-15 repetitions, 5 days per week over 6 months. Patients also attend monthly educational meetings for 6 months.

Вмешательства

• Пищевая добавка Dietary Intervention
  Receive diet plan
• Другое Educational Intervention
  Attend educational meeting
• Поведенческое Exercise Intervention
  Complete exercise program
• Другое Quality-of-Life Assessment
  Ancillary studies
• Другое Survey Administration
  Ancillary studies

Первичные конечные точки

• Changes in body composition [Срок оценки: Baseline up to 6 months]

Вторичные конечные точки (10)

• Changes in muscle strength [Срок оценки: Baseline up to 6 months]
• Changes in functional capacity muscle strength [Срок оценки: Baseline up to 6 months]
• Change in body composition [Срок оценки: Baseline up to 6 months]
• myokines concentration [Срок оценки: Baseline up to 6 months]
• cytokines concentration [Срок оценки: Baseline up to 6 months]
• Health related quality of life Short Form [Срок оценки: Up to 6 months]
• Changes in dietary intake [Срок оценки: Baseline up to 6 months]
• Changes in physical activity [Срок оценки: Baseline up to 6 months]
• Change in fatigue [Срок оценки: Baseline up to 6 months]
• Change in Respiratory Muscle Strength [Срок оценки: Baseline up to 6 months]

Критерии участия

Критерии включения

• Biopsy-confirmed prostate adenocarcinoma of any stage/grade
• Prescribed or already receiving continuous ADT for < 5 years
• Hemoglobin > 11 g/dL
• Creatinine < 1.5 x upper limit of normal (ULN), AST or ALT <2 x ULN within 6 months prior to enrollment
• Liver function tests < 2 x ULN
• Able to walk unassisted at least 100 meters (200 steps) or ECOG <= 1
• No contraindications to any aspect of participation, including aerobic exercise
• Participant must be able to read, write, and understand the English language and be able to provide written consent
• Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Критерии исключения

• Known clinically significant severe chronic obstructive pulmonary disease (COPD), ischemic heart disease, congestive heart failure, and/or significant cardiac arrhythmias
• Limiting orthopedic, musculoskeletal or psychological conditions (clinician discretion)
• Overall medical frailty (clinician discretion)
• Any condition contraindicating additional blood collection beyond standard of care
• Unwilling or unable to follow protocol requirements
• Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study intervention

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Roswell Park Cancer Institute — Buffalo

Идентификаторы

NCT: NCT03880422 · I 72118 · NCI-2019-00341 · I 72118

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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