Resistance Training and Protein Supplementation for Prostate Cancer Survivors
Exercise and Protein Supplementation for Prostate Cancer Survivors Receiving Androgen Deprivation Therapy
Aperçu de l'étude
Statut
Statut
Les conditions
Les conditions
Intervention / Traitement
Intervention / Traitement
Description détaillée
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.
Type d'étude
Type d'étude
Inscription (Réel)
Inscription
Phase
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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California
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Los Angeles, California, États-Unis, 90033
- USC Norris Comprehensive Cancer Center
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-
Critères de participation
Critère d'éligibilité
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Nombre de bras
Armes et Interventions
Groupe de participants / BrasGroupe de participants / Bras |
Intervention / TraitementIntervention / Traitement |
|---|---|
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Expérimental: 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.
|
Études corrélatives
Etudes annexes
Etudes annexes
Autres noms:
Études corrélatives
Autres noms:
Receive whole body RT
Given whey protein supplementation PO
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Expérimental: Arm II (total body RT)
Patients undergo total body RT and stretching as in Arm I.
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Études corrélatives
Etudes annexes
Etudes annexes
Autres noms:
Études corrélatives
Autres noms:
Receive whole body RT
|
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Expérimental: 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.
|
Études corrélatives
Etudes annexes
Etudes annexes
Autres noms:
Études corrélatives
Autres noms:
Given whey protein supplementation PO
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Comparateur actif: 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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Études corrélatives
Etudes annexes
Etudes annexes
Autres noms:
Études corrélatives
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Completion of the resistance training program with at least 80% of the sessions attended
Délai: 12 weeks
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12 weeks
|
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Compliance with protein supplementation
Délai: 12 weeks
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12 weeks
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|
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Change in lean body mass
Délai: 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
Délai: Baseline up to 12 weeks
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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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Parrainer
Collaborateurs
Collaborateurs
Les enquêteurs
Les enquêteurs
- Chercheur principal: E. Todd Schroeder, University of Southern California
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Début de l'étude
Achèvement primaire (Réel)
Achèvement primaire
Achèvement de l'étude (Réel)
Achèvement de l'étude
Dates d'inscription aux études
Première soumission
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Première publication
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour publiée
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
Autres numéros d'identification d'étude
- 4P-13-2
- P30CA014089 (Subvention/contrat des NIH des États-Unis)
- NCI-2013-01360 (Identificateur de registre: CTRP (Clinical Trial Reporting Program))
- HS-13-00315
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