- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03987217
Resistance Training +/- Creatine for Metastatic Prostate Cancer Patients
Creatine Supplementation With Resistance Training: A Novel Approach to Improving Body Composition and Associated Health Outcomes Among Prostate Cancer Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. To evaluate the change in lean mass with 12 weeks of creatine supplementation + resistance training compared to resistance training alone.
SECONDARY OBJECTIVES:
I. To evaluate change in other body composition variables (i.e. fat mass, fat-free mass, percent body fat, appendicular lean mass) with 12 weeks of creatine supplementation + resistance training compared to resistance training alone.
II. To evaluate the change in health outcomes associated with body composition (i.e. physical function, fatigue, insulin regulation) with 12 weeks of creatine supplementation + resistance training compared to resistance training alone.
III. To examine associations between creatine supplementation use and changes in biomarkers linked with prostate cancer progression (prostate specific antigen [PSA] and inflammatory markers).
IV. To evaluate the degree of adherence to the creatine supplementation protocol.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients complete Personal Optimism with Exercise Recovery (POWER) resistance training program sessions twice weekly over 30-60 minute each for 12 weeks.
GROUP II: Patients complete POWER resistance training program sessions twice weekly over 30-60 minutes each for 12 weeks and receive creatine monohydrate supplementation orally (PO) 4 times daily during week 1, and then once daily (QD) during weeks 2-12.
Study Type
Enrollment (Estimated)
Phase
- Early Phase 1
Contacts and Locations
Study Contact
- Name: Susan Sharry
- Phone Number: 801-585-3453
- Email: susan.sharry@hci.utah.edu
Study Locations
-
-
Utah
-
Salt Lake City, Utah, United States, 84112
- Recruiting
- Huntsman Cancer Institute/University of Utah
-
Contact:
- Adriana Coletta
- Email: adriana.coletta@hci.utah.edu
-
Principal Investigator:
- Adriana Coletta
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Metastatic prostate cancer patients who have not met criteria for disease progression on ongoing systemic therapy.
- 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.
- Confirmation by the patient's treating oncologist that the patient is able to start the exercise program.
- Regular access to an electronic device with internet service and ability for video calls (i.e. computer, smart phone, ipad, tablet, etc).
- Access to an active MyChart account or the willingness to create an account for the purposes of the trial.
- Must be able to read and understand English.
- Willingness to engage in a home-based resistance exercise program two days per week.
- If randomized to the creatine + resistance training group, willingness to take creatine monohydrate supplementation for the duration of the 12 week trial and avoid taking additional creatine-containing supplementation or other supplementation during the study period.
- If randomized to the resistance training group without creatine supplementation, willingness to avoid taking creatine monohydrate supplementation or additional creatine-containing supplementation or other supplementation during the study period.
- For participants randomized to the creatine arm willingness to complete and submit Weekly Creatine Supplementation logs to study personnel via email, fax, or in person.
- Willingness to complete two assessment sessions (baseline and end-of-study).
- Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
Exclusion Criteria:
- Treatment with cytotoxic chemotherapy within 12 weeks prior to enrollment.
- Estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73 m^2.
- Metastatic disease that, in the opinion of the treating oncologist, may obstruct compliant participation in the exercise program (i.e. extensive bone disease).
- Current or planned treatment with radiation therapy. *Subjects who may later require radiation therapy for their health and wellbeing during the course of the trial may be allowed to continue on trial, pending consultation with the PI, treating oncologist, and medical monitor (and DSMC as applicable).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group I (resistance training)
Patients complete POWER resistance training program sessions twice weekly over 30-60 minute each for 12 weeks.
|
Ancillary studies
Complete POWER resistance training program
|
Experimental: Group II (resistance training, creatine supplementation)
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.
|
Ancillary studies
Complete POWER resistance training program
Given orally
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in lean mass
Time Frame: Baseline to 12 weeks post intervention
|
Assessed by whole-body dual x-ray absorptiometry (DXA) scan.
|
Baseline to 12 weeks post intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in fat mass
Time Frame: Baseline to 12 weeks post intervention
|
Assess body composition by whole-body DXA (dual x-ray absorptiometry) scan.
|
Baseline to 12 weeks post intervention
|
Change in fat-free mass
Time Frame: Baseline to 12 weeks post intervention
|
Assess body composition by whole-body DXA (dual x-ray absorptiometry) scan.
|
Baseline to 12 weeks post intervention
|
Change in percent body fat
Time Frame: Baseline to 12 weeks post intervention
|
Assess body composition by whole-body DXA (dual x-ray absorptiometry) scan.
|
Baseline to 12 weeks post intervention
|
Change in appendicular lean mass
Time Frame: Baseline to 12 weeks post intervention
|
Assess body composition by whole-body DXA (dual x-ray absorptiometry) scan.
|
Baseline to 12 weeks post intervention
|
Change in physical function
Time Frame: Baseline to 12 weeks post intervention
|
Assessed by physical performance battery testing
|
Baseline to 12 weeks post intervention
|
Change in fatigue
Time Frame: Baseline to 12 weeks post intervention
|
Assessed by Functional Assessment of Chronic Illness Therapy Fatigue (FACIT Fatigue Scale, version 4) questionnaire which is a patient-reported measurement of change in fatigue. Level of fatigue is rated from 0 (not at all) to 4 (very much). FACIT-Fatigue Subscale Scoring Guidelines (Version 4)
|
Baseline to 12 weeks post intervention
|
Change in insulin regulation
Time Frame: Baseline to 12 weeks post intervention
|
Assessed by Homeostatic Model Assessment of Insulin Resistance assessment.
|
Baseline to 12 weeks post intervention
|
Change in serum PSA (prostate specific antigen)
Time Frame: Baseline to 12 weeks post intervention
|
Assessed by PSA lab
|
Baseline to 12 weeks post intervention
|
Total percent of creatine supplementation consumed at end of study
Time Frame: Baseline up to 12 weeks post intervention
|
Assessed by submission of supplementation logs and research pharmacy measurements of remaining creatine in the supplementation containers that will be returned by patients at the end-of-study assessment session.
Pharmacy creatine measurements will be documented in Vestigo.
|
Baseline up to 12 weeks post intervention
|
Change in inflammatory marker interleukin 6 (IL-6)
Time Frame: Baseline to 12 weeks post intervention
|
Assessed by serum testing of inflammatory marker
|
Baseline to 12 weeks post intervention
|
Change in inflammatory marker interleukin 8 (IL-8)
Time Frame: Baseline to 12 weeks post intervention
|
Assessed by serum testing of inflammatory marker
|
Baseline to 12 weeks post intervention
|
Change in inflammatory marker interleukin 10 (IL-10)
Time Frame: Baseline to 12 weeks post intervention
|
Assessed by serum testing of inflammatory marker
|
Baseline to 12 weeks post intervention
|
Change in inflammatory marker tumor necrosis factor alpha (TNF-a)
Time Frame: Baseline to 12 weeks post intervention
|
Assessed by serum testing of inflammatory marker
|
Baseline to 12 weeks post intervention
|
Change in serum glucose
Time Frame: Baseline to 12 weeks post intervention
|
Assessed by serum glucose testing
|
Baseline to 12 weeks post intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Adriana Coletta, Huntsman Cancer Institute/ University of Utah
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HCI120424 (Other Identifier: Huntsman Cancer Institute/University of Utah)
- NCI-2019-02877 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- P30CA042014 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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