This phase III trial compares creatine supplementation in combination with resistance training to placebo (dextrose powder) supplementation in combination with resistance training for preserving muscle mass and improving outcomes in patients who are receiving therapy for prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Treatment of metastatic prostate cancer can cause significant loss of muscle mass, which can lead to reduced survival and quality of life. Creatine helps supply energy to muscle cells for contraction and may improve muscle wasting associated with cancer and other chronic diseases. Resistance training has been shown to preserve muscle mass and improve fatigue, muscle strength, and physical function in patients with non-metastatic prostate cancer. Combining creatine supplementation with resistance training may be more effective at preserving muscle mass and improving other health-related outcomes (fatigue, physical function, strength, etc.) in patients with metastatic prostate cancer than resistance training without creatine.
Additional locations may be listed on ClinicalTrials.gov for NCT06112990.
Locations matching your search criteria
United States
Utah
Salt Lake City
Huntsman Cancer Institute/University of UtahStatus: Active
Contact: Adriana Coletta
Phone: 801-585-0255
PRIMARY OBJECTIVE:
I. To test the efficacy of 52-weeks of home-based, telehealth resistance training (RT) with creatine monohydrate supplementation (Cr) or placebo (PLA), Cr+RT versus (vs.) PLA+RT, on changes in muscle mass in metastatic castration sensitive prostate cancer survivors receiving androgen deprivation therapy (n=200).
OTHER OBJECTIVES:
I. To test the intervention’s effect on fatigue in metastatic castration sensitive prostate cancer survivors receiving androgen deprivation therapy (n=200).
II. To test the intervention’s effect on physical function in metastatic castration sensitive prostate cancer survivors receiving androgen deprivation therapy (n=200).
III. To test the intervention’s effect on strength in metastatic castration sensitive prostate cancer survivors receiving androgen deprivation therapy (n=200).
IV. To test the intervention’s effect on independence in metastatic castration sensitive prostate cancer survivors receiving androgen deprivation therapy (n=200).
V. To test the intervention’s effect on insulin sensitivity in metastatic castration sensitive prostate cancer survivors receiving androgen deprivation therapy (n=200).
VI. To test the intervention’s effect on fat mass in metastatic castration sensitive prostate cancer survivors receiving androgen deprivation therapy (n=200).
VII. To test the intervention’s effect on quality of life in metastatic castration sensitive prostate cancer survivors receiving androgen deprivation therapy (n=200).
VIII. To test the intervention’s effect on markers of cancer progression in metastatic castration sensitive prostate cancer survivors receiving androgen deprivation therapy (n=200).
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I (Cr+RT): Patients receive creatine monohydrate orally (PO) four times daily (QID) in week 1 and then once daily (QD) in weeks 2-52. Patients receive the resistance training intervention via telehealth twice a week (BIW) for 52 weeks. Patients also undergo dual x-ray absorptiometry (DXA) scan and collection of blood samples throughout the trial.
ARM II (PLA+RT): Patients receive dextrose powder PO QID in week 1 and then QD in weeks 2-52. Patients receive the resistance training intervention via telehealth BIW for 52 weeks. Patients also undergo DXA scan and collection of blood samples throughout the trial.
Lead OrganizationHuntsman Cancer Institute/University of Utah
Principal InvestigatorAdriana Coletta
