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FatigueEarly Phase 1NCT03987217

Resistance Training +/- Creatine for Metastatic Prostate Cancer Patients

A Early Phase 1 study testing Creatine Monohydrate, Exercise Intervention and Questionnaire Administration in people with Fatigue and Metastatic Prostate Carcinoma, run by University of Utah at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Creatine Monohydrate, Exercise Intervention and Questionnaire Administration
Could I receive a placebo?
No, everyone receives an active treatment
How many people
73 participants
Where
1 siteUnited States
Study dates
17 Jun 2019to 10 Mar 2025
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 12Show fewer
  • 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.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Huntsman Cancer Institute/University of Utah

    Salt Lake City, Utah, 84112

Other trials in United States

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To evaluate the change in lean mass with 12 weeks of creatine supplementation + resistance training compared to resistance training alone.

SECONDARY OBJECTIVES:

  1. 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 markers of the immune system and allostatic load).

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.

Being tested
Creatine Monohydrate, Exercise Intervention, Questionnaire Administration
Medical subject headings
Fatigue, Prostatic Neoplasms, Sedentary Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Creatine MonohydrateDietary supplement

    Also called Creatine Supplement

    Given orally

  • Exercise InterventionBehavioural

    Complete POWER resistance training program

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT03987217
Study groupRoleWhat they receive
Group I (resistance training)ExperimentalPatients complete POWER resistance training program sessions twice weekly over 30-60 minute each for 12 weeks.
Receives: Behavioral: Exercise Intervention; Other: Questionnaire Administration
Group II (resistance training, creatine supplementation)ExperimentalPatients 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.
Receives: Dietary Supplement: Creatine Monohydrate; Behavioral: Exercise Intervention; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in lean mass

    Assessed by whole-body dual x-ray absorptiometry (DXA) scan.

    Measured: Baseline to 12 weeks post intervention

Secondary outcomes (13)

  1. Change in fat mass

    Assess body composition by whole-body DXA (dual x-ray absorptiometry) scan.

    Measured: Baseline to 12 weeks post intervention

  2. Change in fat-free mass

    Assess body composition by whole-body DXA (dual x-ray absorptiometry) scan.

    Measured: Baseline to 12 weeks post intervention

  3. Change in percent body fat

    Assess body composition by whole-body DXA (dual x-ray absorptiometry) scan.

    Measured: Baseline to 12 weeks post intervention

  4. Change in appendicular lean mass

    Assess body composition by whole-body DXA (dual x-ray absorptiometry) scan.

    Measured: Baseline to 12 weeks post intervention

  5. Change in physical function

    Assessed by physical performance battery testing

    Measured: Baseline to 12 weeks post intervention

  6. 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)

    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.

    Measured: Baseline to 12 weeks post intervention

  7. Change in insulin regulation

    Assessed by Homeostatic Model Assessment of Insulin Resistance assessment.

    Measured: Baseline to 12 weeks post intervention

  8. Change in serum PSA (prostate specific antigen) markers of the immune system and allostatic load

    Assessed by PSA lab

    Measured: Baseline to 12 weeks post intervention

  9. Plasma markers of allostatic load: Interleukin-6 (IL-6)

    Change in IL-6 will be assessed by serum IL-6 testing.

    Measured: Baseline to 12 weeks post intervention

  10. Plasma markers of allostatic load: Insulin

    Changes in insulin will be assessed by serum insulin testing.

    Measured: Baseline to 12 weeks post intervention

  11. Plasma markers of allostatic load: Glucose

    Changes in glucose will be assessed by serum glucose testing.

    Measured: Baseline to 12 weeks post intervention

  12. 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.

    Measured: Baseline up to 12 weeks post intervention

  13. Plasma markers of the immune system

    Changes in plasma markers of the immune system.

    Measured: Baseline up to 12 weeks post intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2019
  2. Study start17 Jun 2019
  3. Primary completion10 Mar 2025
  4. Study completion10 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
73 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03987217
Sponsor's protocol ID
HCI120424
Other IDs
NCI-2019-02877, HCI120424, P30CA042014
Status last verified
May 2025
First submitted
3 Jun 2019
Last updated
14 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Creatine Monohydrate, Exercise Intervention and Questionnaire Administration in people with Fatigue and Metastatic Prostate Carcinoma, run by University of Utah at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in lean mass (time frame: Baseline to 12 weeks post intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03987217.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.

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