Resistance Training +/- Creatine for Metastatic Prostate Cancer Patients

Fatigue Clinical Trial

Official title:

Creatine Supplementation With Resistance Training: A Novel Approach to Improving Body Composition and Associated Health Outcomes Among Prostate Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03987217
• Other study ID #: HCI120424
• Secondary ID: NCI-2019-02877HC
• Status: Recruiting
• Phase: Early Phase 1
• Start date: June 17, 2019
• Est. completion date: June 7, 2026

Study information

• Verified date: April 2024
• Source: University of Utah
• Contact: Susan Sharry
• Phone: 801-585-3453
• Email: susan.sharry[@]hci.utah.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial studies how well resistance training with or without creatine monohydrate supplement works in improving body composition and health outcomes in patients with prostate cancer that has spread to other places in the body. Resistance training, with or without creatine monohydrate supplement, may help to improve feelings of tiredness and overall physical function in patients with prostate cancer.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 7, 2026
• Est. primary completion date: June 7, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Fatigue
• Metastatic Prostate Carcinoma
• Prostatic Neoplasms
• Sedentary Lifestyle
• Stage IV Prostate Cancer AJCC (American Joint Committee on Cancer) v8
• Stage IVA Prostate Cancer AJCC (American Joint Committee on Cancer) v8
• Stage IVB Prostate Cancer AJCC (American Joint Committee on Cancer) v8

Intervention

Dietary Supplement:
• Creatine Monohydrate
Given orally

Behavioral:
• Exercise Intervention
Complete POWER resistance training program

Other:
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Huntsman Cancer Institute/University of Utah	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in lean mass	Assessed by whole-body dual x-ray absorptiometry (DXA) scan.	Baseline to 12 weeks post intervention
Secondary	Change in fat mass	Assess body composition by whole-body DXA (dual x-ray absorptiometry) scan.	Baseline to 12 weeks post intervention
Secondary	Change in fat-free mass	Assess body composition by whole-body DXA (dual x-ray absorptiometry) scan.	Baseline to 12 weeks post intervention
Secondary	Change in percent body fat	Assess body composition by whole-body DXA (dual x-ray absorptiometry) scan.	Baseline to 12 weeks post intervention
Secondary	Change in appendicular lean mass	Assess body composition by whole-body DXA (dual x-ray absorptiometry) scan.	Baseline to 12 weeks post intervention
Secondary	Change in physical function	Assessed by physical performance battery testing	Baseline to 12 weeks post intervention
Secondary	Change in fatigue	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); Record answers in "item response" column. If missing, mark with an X; Perform reversals as indicated, and sum individual items to obtain a score.; Multiply the sum of the item scores by the number of items in the subscale, then divide by the number of items answered. This produces the subscale score.; The higher the score, the better the QOL.	Baseline to 12 weeks post intervention
Secondary	Change in insulin regulation	Assessed by Homeostatic Model Assessment of Insulin Resistance assessment.	Baseline to 12 weeks post intervention
Secondary	Change in serum PSA (prostate specific antigen)	Assessed by PSA lab	Baseline to 12 weeks post intervention
Secondary	Total percent of creatine supplementation consumed at end of study	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
Secondary	Change in inflammatory marker interleukin 6 (IL-6)	Assessed by serum testing of inflammatory marker	Baseline to 12 weeks post intervention
Secondary	Change in inflammatory marker interleukin 8 (IL-8)	Assessed by serum testing of inflammatory marker	Baseline to 12 weeks post intervention
Secondary	Change in inflammatory marker interleukin 10 (IL-10)	Assessed by serum testing of inflammatory marker	Baseline to 12 weeks post intervention
Secondary	Change in inflammatory marker tumor necrosis factor alpha (TNF-a)	Assessed by serum testing of inflammatory marker	Baseline to 12 weeks post intervention
Secondary	Change in serum glucose	Assessed by serum glucose testing	Baseline to 12 weeks post intervention