Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Resistance Training +/- Creatine for Metastatic Prostate Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03987217
Recruitment Status : Recruiting
First Posted : June 14, 2019
Last Update Posted : September 6, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Utah

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.

Condition or disease Intervention/treatment Phase
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 Dietary Supplement: Creatine Monohydrate Behavioral: Exercise Intervention Other: Questionnaire Administration Early Phase 1

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Creatine Supplementation With Resistance Training: A Novel Approach to Improving Body Composition and Associated Health Outcomes Among Prostate Cancer Patients
Actual Study Start Date : June 17, 2019
Estimated Primary Completion Date : June 7, 2024
Estimated Study Completion Date : June 7, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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.
Behavioral: Exercise Intervention
Complete POWER resistance training program

Other: Questionnaire Administration
Ancillary studies

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.
Dietary Supplement: Creatine Monohydrate
Given orally
Other Name: Creatine Supplement

Behavioral: Exercise Intervention
Complete POWER resistance training program

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  1. Change in lean mass [ Time Frame: Baseline to 12 weeks post intervention ]
    Assessed by whole-body dual x-ray absorptiometry (DXA) scan.


Secondary Outcome Measures :
  1. Change in fat mass [ Time Frame: Baseline to 12 weeks post intervention ]
    Assess body composition by whole-body DXA (dual x-ray absorptiometry) scan.

  2. 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.

  3. 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.

  4. 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.

  5. Change in physical function [ Time Frame: Baseline to 12 weeks post intervention ]
    Assessed by physical performance battery testing

  6. 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)

    1. Record answers in "item response" column. If missing, mark with an X
    2. Perform reversals as indicated, and sum individual items to obtain a score.
    3. 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.
    4. The higher the score, the better the QOL.

  7. Change in insulin regulation [ Time Frame: Baseline to 12 weeks post intervention ]
    Assessed by Homeostatic Model Assessment of Insulin Resistance assessment.

  8. Change in serum PSA (prostate specific antigen) [ Time Frame: Baseline to 12 weeks post intervention ]
    Assessed by PSA lab

  9. 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 supplementation containers that will be returned at the end-of-study assessment session.

  10. Change in inflammatory marker interleukin 6 (IL-6) [ Time Frame: Baseline to 12 weeks post intervention ]
    Assessed by serum testing of inflammatory marker

  11. Change in inflammatory marker interleukin 8 (IL-8) [ Time Frame: Baseline to 12 weeks post intervention ]
    Assessed by serum testing of inflammatory marker

  12. Change in inflammatory marker interleukin 10 (IL-10) [ Time Frame: Baseline to 12 weeks post intervention ]
    Assessed by serum testing of inflammatory marker

  13. 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

  14. Change in serum glucose [ Time Frame: Baseline to 12 weeks post intervention ]
    Assessed by serum glucose testing



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Metastatic prostate cancer patients who have not met criteria for disease progression on ongoing systemic therapy.
  • Currently treated with CYP17A1 inhibitors, 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.
  • Physically able to enroll in the Huntsman Cancer Institute (HCI) Personal Optimism with Exercise Recovery (POWER) fitness program, as determined by the patient's treating oncologist. This determination may be made in conjunction with the Huntsman Wellness Center team.
  • Sedentary activity pattern: < 30 minutes per week of structured moderate- or vigorous-intensity aerobic exercise and not currently engaging in structured resistance exercise.

    • Definitions:

      • Structured = time set aside specifically to engage in moderate- or vigorous-intensity aerobic exercise.
      • Moderate-intensity aerobic activity = you can talk during the exercise but can?t sing.
      • Vigorous-intensity aerobic activity = you can only say a few words while exercising.
      • Resistance exercise = time set aside specifically to complete body weight training, or exercises with resistance bands, free weights or weight machines.
  • A response of at least 4 on a 10-point scale (with 0 = not tired at all and 10 = extremely tired) to the question ?How tired did you feel in the past week??
  • 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.
  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03987217


Contacts
Layout table for location contacts
Contact: Sally Fairbairn 801-587-4765 Sally.Fairbairn@hci.utah.edu

Locations
Layout table for location information
United States, Utah
Huntsman Cancer Institute/University of Utah Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Adriana Coletta       adriana.coletta@hci.utah.edu   
Principal Investigator: Adriana Coletta         
Sponsors and Collaborators
University of Utah
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Adriana Coletta Huntsman Cancer Institute/ University of Utah

Layout table for additonal information
Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT03987217     History of Changes
Other Study ID Numbers: HCI120424
NCI-2019-02877 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
HCI120424 ( Other Identifier: Huntsman Cancer Institute/University of Utah )
P30CA042014 ( U.S. NIH Grant/Contract )
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: September 2019

Layout table for additional information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Fatigue
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Signs and Symptoms