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Resistance Training +/− Creatine for Prostate Cancer
Phase < 1
Recruiting
Led By Adriana Coletta
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Currently treated with CYP17A1 inhibitors, surgical castration or medical castration with GnRH (gonadotropin-releasing hormone) agonists/antagonists, or androgen receptor blockers. Must have started the current regimen at least 12 weeks prior to enrollment
Metastatic prostate cancer patients who have not met criteria for disease progression on ongoing systemic therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 12 weeks post intervention
Awards & highlights
Study Summary
This trial is testing whether resistance training, with or without creatine, can improve body composition and health outcomes in patients with prostate cancer that has spread.
Who is the study for?
This trial is for metastatic prostate cancer patients who can read English, have internet access for video calls, and are willing to do a home-based exercise program. They must be on certain cancer treatments for at least 12 weeks before joining and get their oncologist's okay to start exercising.Check my eligibility
What is being tested?
The study looks at whether resistance training improves body composition and health in prostate cancer patients with fatigue. It compares the effects of doing exercises alone or combined with a creatine supplement over 12 weeks.See study design
What are the potential side effects?
Potential side effects may include muscle cramps or digestive issues from creatine monohydrate, as well as general risks associated with resistance training like muscle soreness or injury.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I've been on hormone therapy for prostate cancer for at least 12 weeks.
Select...
My prostate cancer has spread, but it hasn't gotten worse on my current treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 12 weeks post intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 12 weeks post intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in lean mass
Secondary outcome measures
Change in appendicular lean mass
Change in fat mass
Change in fat-free mass
+11 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Group II (resistance training, creatine supplementation)Experimental Treatment3 Interventions
Patients complete POWER resistance training program sessions twice weekly over 30-60 minutes each for 12 weeks and receive creatine monohydrate supplementation given orally 4 times daily during week 1, and then QD (once per day) during weeks 2-12.
Group II: Group I (resistance training)Experimental Treatment2 Interventions
Patients complete POWER resistance training program sessions twice weekly over 30-60 minute each for 12 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Exercise Intervention
2016
Completed Phase 4
~1330
Creatine Monohydrate
2009
Completed Phase 2
~170
Find a Location
Who is running the clinical trial?
University of UtahLead Sponsor
1,099 Previous Clinical Trials
1,778,589 Total Patients Enrolled
8 Trials studying Prostate Cancer
5,349 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,754 Total Patients Enrolled
561 Trials studying Prostate Cancer
507,095 Patients Enrolled for Prostate Cancer
Adriana ColettaPrincipal InvestigatorHuntsman Cancer Institute/ University of Utah
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had chemotherapy in the last 12 weeks.My doctor thinks my cancer spread won't stop me from joining the exercise program.I am willing to not take any creatine supplements if I join the resistance training group.My kidney function is severely reduced.I've been on hormone therapy for prostate cancer for at least 12 weeks.I am willing to take creatine and do resistance training without using other supplements for 12 weeks.I am willing to complete two assessment sessions.You are willing to do resistance exercise at home two days a week.My prostate cancer has spread, but it hasn't gotten worse on my current treatment.I am willing to track and share my creatine intake weekly if assigned to that group.I am currently receiving or will receive radiation therapy.
Research Study Groups:
This trial has the following groups:- Group 1: Group II (resistance training, creatine supplementation)
- Group 2: Group I (resistance training)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any opportunities for participation in this experiment currently available?
"Indeed. According to clinicaltrials.gov, this study is actively seeking new participants and was initially posted on June 17th 2019 with its last edit occurring January 11th 2022. A total of 85 patients are needed from one location for the trial's completion."
Answered by AI
How many participants are being observed in this research endeavor?
"Affirmative. Data hosted on the clinicaltrials.gov website reveals that this study, which was initially advertised on June 17th 2019, is still open for recruitment. 85 participants need to be enrolled from 1 medical centre."
Answered by AI
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