Nutrition and Exercise Interventions in Reducing Androgen Deprivation Therapy-Induced Obese Frailty in Prostate Cancer Survivors
Ключови думи
Резюме
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.
Дати
| Последна проверка: | 06/30/2020 |
| Първо изпратено: | 02/28/2019 |
| Очаквано записване подадено: | 03/14/2019 |
| Първо публикувано: | 03/18/2019 |
| Изпратена последна актуализация: | 07/06/2020 |
| Последна актуализация публикувана: | 07/07/2020 |
| Действителна начална дата на проучването: | 01/02/2019 |
| Приблизителна дата на първично завършване: | 01/02/2021 |
| Очаквана дата на завършване на проучването: | 01/02/2022 |
Състояние или заболяване
Интервенция / лечение
Dietary Supplement: Supportive care (diet, exercise, education)
Other: Supportive care (diet, exercise, education)
Behavioral: Supportive care (diet, exercise, education)
Other: Supportive care (diet, exercise, education)
Other: Supportive care (diet, exercise, education)
Фаза
Групи за ръце
| Arm | Интервенция / лечение |
|---|---|
| Experimental: Supportive care (diet, exercise, education) 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. | Dietary Supplement: Supportive care (diet, exercise, education) Receive diet plan |
Критерии за допустимост
| Възрасти, отговарящи на условията за проучване | 18 Years Да се 18 Years |
| Полове, допустими за проучване | Male |
| Приема здрави доброволци | Да |
| Критерии | Inclusion Criteria: - 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 - Body mass index (BMI) > 25.0 (overweight and obese) - 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 Exclusion Criteria: - 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) - Patients on ADT with concurrent chemotherapy, immunotherapy and/or radiotherapy. Palliative radiation okay. - 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 |
Резултат
Първични изходни мерки
1. Changes in body composition [Baseline up to 6 months]
Вторични изходни мерки
1. Changes in muscle strength [Baseline up to 6 months]
2. Changes in functional capacity muscle strength [Baseline up to 6 months]
3. Change in body composition [Baseline up to 6 months]
4. myokines concentration [Baseline up to 6 months]
5. cytokines concentration [Baseline up to 6 months]
6. Health related quality of life Short Form [Up to 6 months]
7. Changes in dietary intake [Baseline up to 6 months]
8. Changes in physical activity [Baseline up to 6 months]
9. Change in fatigue [Baseline up to 6 months]
10. Change in Respiratory Muscle Strength [Baseline up to 6 months]
Други изходни мерки
1. Serum prostate specific antigen (PSA) and androgen levels [Up to 6 months]
2. Adherence to nutrition and exercise advice [Up to 6 months]
