- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT01909440
Resistance Training and Protein Supplementation for Prostate Cancer Survivors
Exercise and Protein Supplementation for Prostate Cancer Survivors Receiving Androgen Deprivation Therapy
Przegląd badań
Status
Warunki
Szczegółowy opis
PRIMARY OBJECTIVES:
I. To examine the effects of progressive, structured resistance training (RT) program , with and without protein supplementation (PS), on lean body mass (LBM) in prostate cancer survivors (PCS) on androgen deprivation therapy (ADT). Increases in LBM may influence additional outcomes such as physical function, quality of life (QOL) and molecular pathways that regulate skeletal muscle.
SECONDARY OBJECTIVES:
I. To examine the effects of a structured RT program, with and without PS, on muscle strength, physical function, and QOL in PCS on ADT .
TERTIARY OBJECTIVES:
I. To examine the effects of a progressive, structured RT program, with and without PS, on anabolic and catabolic molecular regulators of skeletal muscle in PCS on ADT.
II. To examine the effects of a progressive, structured RT program, with and without PS, on bone turnover markers and bone mineral density in PCS on ADT.
OUTLINE: Patients are randomized to 1 of 4 arms.
ARM I: Patients undergo total body high-intensity RT thrice weekly, and perform static stretching exercises after each session. Exercises progress from low intensity and high volume to higher intensity and lower volume over the course of the 12-week program. Patients also receive whey protein supplementation orally twice a day for 12 weeks.
ARM II: Patients undergo total body RT and stretching as in Arm I.
ARM III: Patients receive whey protein supplementation as in Arm I. Patients also undergo a home flexibility program 3 times per week, consisting of the same static stretching exercises performed after RT. After 12 weeks, may undergo the RT program as in Arm 1.
ARM IV: Patients undergo the home flexibility program as in Arm III. After 12 weeks, patient may undergo total body RT as in Arm 1.
After completion of study treatment, patients are followed up periodically.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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California
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Los Angeles, California, Stany Zjednoczone, 90033
- USC Norris Comprehensive Cancer Center
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
Diagnosed with prostate cancer
- Treatment with androgen deprivation therapy (ADT) (gonadotropin-releasing hormone [GnRH] agonist/antagonist with or without anti-androgen) for prostate cancer
- Receiving ADT for a minimum of 12 weeks before enrollment into the study
- Planned ADT for the duration of the 12-week study period
Asymptomatic, or minimally symptomatic from prostate cancer or prostate cancer related therapies
- No opioid-requiring cancer related pain
- Any therapy related genitourinary or gastrointestinal symptoms should be considered as mild (Common Terminology Criteria for Adverse Events [CTCAE] grade 1 or 2) and not interfering with activities of daily living
- Permission from treating/study physician to participate in RT
Exclusion Criteria:
- No concurrent use of chemotherapy or radiotherapy (radiotherapy should be completed at least 4 weeks from study entry)
- History of allergic reactions to whey protein
- Milk protein intolerance/allergies (lactose intolerance is acceptable)
- Subjects currently using N-acetylcysteine, alpha-lipoic acid supplements, or dry whey protein supplements
- Recovered from major surgery within the last 6 months
- Acute coronary (e.g. myocardial infarction) or vascular event within the last year as well as uncontrolled coronary heart disease (e.g. progressive angina)
- Stroke within the past 2 years
- Neurologic and/or orthopedic limitations that preclude the participation in the training program (e.g. bone metastases that may pose a high risk of pathologic fracture)
- Subjects currently participating in a RT program
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: Arm I (RT + PS)
Patients undergo total body high-intensity RT thrice weekly and perform static stretching exercises after each session.
Exercises progress from low intensity and high volume to higher intensity and lower volume over the course of the 12-week program.
Patients also receive whey protein supplementation orally twice a day for 12 weeks.
|
Badania korelacyjne
Badania pomocnicze
Badania pomocnicze
Inne nazwy:
Badania korelacyjne
Inne nazwy:
Receive whole body RT
Given whey protein supplementation PO
|
|
Eksperymentalny: Arm II (total body RT)
Patients undergo total body RT and stretching as in Arm I.
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Badania korelacyjne
Badania pomocnicze
Badania pomocnicze
Inne nazwy:
Badania korelacyjne
Inne nazwy:
Receive whole body RT
|
|
Eksperymentalny: Arm III (protein supplementation)
Patients receive whey protein supplementation as in Arm I. Patients also undergo a home flexibility program 3 times per week, consisting of the same static stretching exercises performed after RT.
After 12 weeks, patients may undergo the RT program as in Arm I.
|
Badania korelacyjne
Badania pomocnicze
Badania pomocnicze
Inne nazwy:
Badania korelacyjne
Inne nazwy:
Given whey protein supplementation PO
|
|
Aktywny komparator: Arm IV (attention control)
Patients undergo the home flexibility program as in Arm III.
After 12 weeks, patients may undergo total body RT as in Arm I.
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Badania korelacyjne
Badania pomocnicze
Badania pomocnicze
Inne nazwy:
Badania korelacyjne
Inne nazwy:
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Completion of the resistance training program with at least 80% of the sessions attended
Ramy czasowe: 12 weeks
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12 weeks
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Compliance with protein supplementation
Ramy czasowe: 12 weeks
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12 weeks
|
|
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Change in lean body mass
Ramy czasowe: Baseline up to 12 weeks
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Intent-to-treat models will be computed using repeated measures analysis of variance (ANOVA).
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Baseline up to 12 weeks
|
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Change in strength
Ramy czasowe: Baseline up to 12 weeks
|
Intent-to-treat models will be computed using repeated measures ANOVA.
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Baseline up to 12 weeks
|
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Change in quality of life
Ramy czasowe: Baseline up to 12 weeks
|
Intent-to-treat models will be computed using repeated measures ANOVA.
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Baseline up to 12 weeks
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Współpracownicy i badacze
Współpracownicy
Śledczy
- Główny śledczy: E. Todd Schroeder, University of Southern California
Publikacje i pomocne linki
Publikacje ogólne
- Dawson JK, Dorff TB, Tuzon C, Rice JC, Schroeder ET, Lane CJ, Gross ME, Dieli-Conwright CM. Effect of Periodized Resistance Training on Skeletal Muscle During Androgen Deprivation Therapy for Prostate Cancer: A Pilot Randomized Trial. Integr Cancer Ther. 2021 Jan-Dec;20:15347354211035442. doi: 10.1177/15347354211035442.
- Dawson JK, Dorff TB, Todd Schroeder E, Lane CJ, Gross ME, Dieli-Conwright CM. Impact of resistance training on body composition and metabolic syndrome variables during androgen deprivation therapy for prostate cancer: a pilot randomized controlled trial. BMC Cancer. 2018 Apr 3;18(1):368. doi: 10.1186/s12885-018-4306-9.
- Kiwata JL, Dorff TB, Todd Schroeder E, Salem GJ, Lane CJ, Rice JC, Gross ME, Dieli-Conwright CM. A pilot randomised controlled trial of a periodised resistance training and protein supplementation intervention in prostate cancer survivors on androgen deprivation therapy. BMJ Open. 2017 Jul 10;7(7):e016910. doi: 10.1136/bmjopen-2017-016910.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 4P-13-2
- P30CA014089 (Grant/umowa NIH USA)
- NCI-2013-01360 (Identyfikator rejestru: CTRP (Clinical Trial Reporting Program))
- HS-13-00315
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