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Resistance Training +/- Creatine for Metastatic Prostate Cancer Patients

Primary Purpose

Fatigue, Metastatic Prostate Carcinoma, Sedentary Lifestyle

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Creatine Monohydrate
Exercise Intervention
Questionnaire Administration
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fatigue

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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 Creatinine 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).

Sites / Locations

  • Huntsman Cancer Institute/University of UtahRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group I (resistance training)

Group II (resistance training, creatine supplementation)

Arm Description

Patients complete POWER resistance training program sessions twice weekly over 30-60 minute each for 12 weeks.

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.

Outcomes

Primary Outcome Measures

Change in lean mass
Assessed by whole-body dual x-ray absorptiometry (DXA) scan.

Secondary Outcome Measures

Change in fat mass
Assess body composition by whole-body DXA (dual x-ray absorptiometry) scan.
Change in fat-free mass
Assess body composition by whole-body DXA (dual x-ray absorptiometry) scan.
Change in percent body fat
Assess body composition by whole-body DXA (dual x-ray absorptiometry) scan.
Change in appendicular lean mass
Assess body composition by whole-body DXA (dual x-ray absorptiometry) scan.
Change in physical function
Assessed by physical performance battery testing
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.
Change in insulin regulation
Assessed by Homeostatic Model Assessment of Insulin Resistance assessment.
Change in serum PSA (prostate specific antigen)
Assessed by PSA lab
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.
Change in inflammatory marker interleukin 6 (IL-6)
Assessed by serum testing of inflammatory marker
Change in inflammatory marker interleukin 8 (IL-8)
Assessed by serum testing of inflammatory marker
Change in inflammatory marker interleukin 10 (IL-10)
Assessed by serum testing of inflammatory marker
Change in inflammatory marker tumor necrosis factor alpha (TNF-a)
Assessed by serum testing of inflammatory marker
Change in serum glucose
Assessed by serum glucose testing

Full Information

First Posted
June 3, 2019
Last Updated
January 11, 2023
Sponsor
University of Utah
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03987217
Brief Title
Resistance Training +/- Creatine for Metastatic Prostate Cancer Patients
Official Title
Creatine Supplementation With Resistance Training: A Novel Approach to Improving Body Composition and Associated Health Outcomes Among Prostate Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 17, 2019 (Actual)
Primary Completion Date
June 7, 2024 (Anticipated)
Study Completion Date
June 7, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Utah
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue, Metastatic Prostate Carcinoma, 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

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
85 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group I (resistance training)
Arm Type
Experimental
Arm Description
Patients complete POWER resistance training program sessions twice weekly over 30-60 minute each for 12 weeks.
Arm Title
Group II (resistance training, creatine supplementation)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Creatine Monohydrate
Other Intervention Name(s)
Creatine Supplement
Intervention Description
Given orally
Intervention Type
Behavioral
Intervention Name(s)
Exercise Intervention
Intervention Description
Complete POWER resistance training program
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Change in lean mass
Description
Assessed by whole-body dual x-ray absorptiometry (DXA) scan.
Time Frame
Baseline to 12 weeks post intervention
Secondary Outcome Measure Information:
Title
Change in fat mass
Description
Assess body composition by whole-body DXA (dual x-ray absorptiometry) scan.
Time Frame
Baseline to 12 weeks post intervention
Title
Change in fat-free mass
Description
Assess body composition by whole-body DXA (dual x-ray absorptiometry) scan.
Time Frame
Baseline to 12 weeks post intervention
Title
Change in percent body fat
Description
Assess body composition by whole-body DXA (dual x-ray absorptiometry) scan.
Time Frame
Baseline to 12 weeks post intervention
Title
Change in appendicular lean mass
Description
Assess body composition by whole-body DXA (dual x-ray absorptiometry) scan.
Time Frame
Baseline to 12 weeks post intervention
Title
Change in physical function
Description
Assessed by physical performance battery testing
Time Frame
Baseline to 12 weeks post intervention
Title
Change in fatigue
Description
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.
Time Frame
Baseline to 12 weeks post intervention
Title
Change in insulin regulation
Description
Assessed by Homeostatic Model Assessment of Insulin Resistance assessment.
Time Frame
Baseline to 12 weeks post intervention
Title
Change in serum PSA (prostate specific antigen)
Description
Assessed by PSA lab
Time Frame
Baseline to 12 weeks post intervention
Title
Total percent of creatine supplementation consumed at end of study
Description
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.
Time Frame
Baseline up to 12 weeks post intervention
Title
Change in inflammatory marker interleukin 6 (IL-6)
Description
Assessed by serum testing of inflammatory marker
Time Frame
Baseline to 12 weeks post intervention
Title
Change in inflammatory marker interleukin 8 (IL-8)
Description
Assessed by serum testing of inflammatory marker
Time Frame
Baseline to 12 weeks post intervention
Title
Change in inflammatory marker interleukin 10 (IL-10)
Description
Assessed by serum testing of inflammatory marker
Time Frame
Baseline to 12 weeks post intervention
Title
Change in inflammatory marker tumor necrosis factor alpha (TNF-a)
Description
Assessed by serum testing of inflammatory marker
Time Frame
Baseline to 12 weeks post intervention
Title
Change in serum glucose
Description
Assessed by serum glucose testing
Time Frame
Baseline to 12 weeks post intervention

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 Creatinine 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sally Fairbairn
Phone
801-587-4765
Email
Sally.Fairbairn@hci.utah.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adriana Coletta
Organizational Affiliation
Huntsman Cancer Institute/ University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
Huntsman Cancer Institute/University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adriana Coletta
Email
adriana.coletta@hci.utah.edu
First Name & Middle Initial & Last Name & Degree
Adriana Coletta

12. IPD Sharing Statement

Plan to Share IPD
No

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Resistance Training +/- Creatine for Metastatic Prostate Cancer Patients

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