Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Prostatic Neoplasms

Disease Progression

Disease Attributes

Anti-Arrhythmia Agents

Vasodilator Agents

Analgesics

All Drugs and Chemicals

Cardiotonic Agents

Other Dietary Supplements

Adenosine

Phosphocreatine

Creatine

Home-based, telehealth resistance training (RT) with creatine monohydrate supplementation (Cr)

Home-based, telehealth resistance training (RT) with placebo (PLA)

Creatine is part of the phosphagen system and plays a critical role in energy metabolism. Creatine monohydrate supplementation increases availability of creatine and phosphocreatine in the skeletal muscle. Increased phosphocreatine enables greater buffering of adenosine triphosphate, an organic compound providing energy to cells, enhancing training volume (e.g., an individual can work-out harder and longer).This augmentation in exercise capacity amplifies training adaptations. Additionally, creatine monohydrate supplementation reduces levels of inflammatory markers, which are associated with severe muscle loss.

creatine monohydrate

Placebo supplementation consists of a flavorless, colorless, dextrose powder and will be supplied in concealed, unlabeled packaging.

Placebo

Home-based, individualized, whole-body RT program, supervised via the telehealth platform within the electronic medical record system. The RT program consists of 12 resistance exercises, focusing on all major muscle groups including upper and lower body, core, and whole-body. Exercises within each participant's individualized RT program progress with a periodization model as recommended by the American College of Sports Medicine. In addition, the cancer exercise trainer will inquire about space availability in the home for completing resistance prior to developing the personalized prescription. This logistical information is key to ensure feasibility of completing the exercises prescribed. Participants will be provided with beginner and advanced sets of elastic resistance bands to enable progression throughout the 52-week study.

Home-based, telehealth

Susan Sharry

Adriana Coletta, PHD, MS, RD

Adriana Coletta, PhD, MS, RD

The goal of this clinical trial is to test the use of creatine monohydrate supplementation with resistance training to preserve muscle mass and help lessen prostate cancer progression.

The main question it aims to answer is if this treatment will help maintain muscle mass to help in reducing fatigue and improving physical function, independence, and quality of life.

Participants will be asked to participate in a 52-week exercise intervention consisting of a twice weekly telehealth resistance training program.

This is a parallel, double-blind randomized controlled trial to test the effects of 52-weeks of creatine monohydrate supplementation with resistance training (Cr+RT) compared with placebo (PLA) and RT (PLA+RT) with our team's established, effective, home-based, telehealth RT program in 200 metastatic castration sensitive prostate cancer (mCSPC) survivors receiving androgen deprivation therapy (ADT). We will evaluate muscle mass, health outcomes (fatigue, physical function, independence, insulin sensitivity, quality of life), and markers or cancer progression (prostate specific antigen, cell-free DNA) at baseline, 24-, and 52-weeks. RT will be carried out twice weekly with elastic resistance bands, and we will utilize an established creatine monohydrate supplementation protocol for creatine and PLA delivery.

Double-blind, placebo-controlled, randomized, controlled trial

The participants, the investigators, and all members of the study team will be blinded to the treatment assignment.

Creatine Supplementation and Resistance Training to Preserve Muscle Mass and Attenuate Cancer Progression

Creatine Supplementation and Resistance Training to Preserve Muscle Mass and Attenuate Cancer Progression: A Double-Blind Randomized Controlled Trial

To test the intervention's effect on fatigue in metastatic castration sensitive prostate cancer survivors receiving androgen deprivation therapy (n=200).

To test the intervention's effect on physical function in metastatic castration sensitive prostate cancer survivors receiving androgen deprivation therapy (n=200).

To test the intervention's effect on strength in metastatic castration sensitive prostate cancer survivors receiving androgen deprivation therapy (n=200).

To test the intervention's effect on independence in metastatic castration sensitive prostate cancer survivors receiving androgen deprivation therapy (n=200).

To test the intervention's effect on insulin sensitivity in metastatic castration sensitive prostate cancer survivors receiving androgen deprivation therapy (n=200) .

To test the intervention's effect on fat mass in metastatic castration sensitive prostate cancer survivors receiving androgen deprivation therapy (n=200) .

To test the intervention's effect on quality of life in metastatic castration sensitive prostate cancer survivors receiving androgen deprivation therapy (n=200) .

To test the intervention's effect on markers of cancer progression in metastatic castration sensitive prostate cancer survivors receiving androgen deprivation therapy (n=200) .

To test the efficacy of 52-weeks of home-based, telehealth resistance training (RT) with creatine monohydrate supplementation (Cr) or placebo (PLA), Cr+RT vs. PLA+RT, on changes in muscle mass in metastatic castration sensitive prostate cancer survivors receiving androgen deprivation therapy (n=200).

National Cancer Institute (NCI)

University of Utah

Nutritional and Metabolic Diseases

Weight Loss

Anorexia

Body Weight

Body Weight Changes

Wasting Syndrome

Cachexia

Syndrome

Signs and Symptoms, Digestive

Thinness

Metabolic Diseases

Nutrition Disorders

placebo

Aminah Jatoi, MD

RATIONALE: It is not yet known whether the supplement creatine is effective in increasing weight and improving appetite and quality of life in patients who have cancer.

PURPOSE: This randomized phase III trial is studying how well creatine works in increasing weight and improving appetite and quality of life in patients with weight loss caused by cancer.

OBJECTIVES:

* Compare weight-gain effects of creatine vs placebo in patients with cancer-associated weight loss and/or anorexia.
* Determine the effect of these regimens on quality of life in these patients.
* Compare the toxic effects of these regimens in these patients.
* Compare survival rates of patients treated with these regimens.

OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to primary cancer type (lung vs gastrointestinal vs other), weight loss severity (\< 10 lbs vs ≥10 lbs), age (\< 50 years vs ≥ 50 years), planned concurrent chemotherapy (yes vs no), gender, and prognosis. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive oral creatine daily.
* Arm II: Patients receive oral placebo daily. In both arms, treatment continues in the absence of unacceptable toxicity as long as treatment is considered beneficial.

Patients are followed every 6 months for up to 5 years.

PROJECTED ACCRUAL: A total of 300 patients will be accrued for this study.

Creatine in Treating Patients With Cancer-Associated Weight Loss

Phase III Double-Blind, Placebo-Controlled Randomized Comparison of Creatine for Cancer-Associated Weight Loss

Alliance for Clinical Trials in Oncology

Fatigue

Carcinoma

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

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.

Creatine Monohydrate

Complete POWER resistance training program

Exercise Intervention

Questionnaire Administration

Adriana Coletta

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.

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.

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

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

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

Assessed by physical performance battery testing

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.

Assessed by Homeostatic Model Assessment of Insulin Resistance assessment.

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.

Assessed by serum testing of inflammatory marker

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Creatine Supplementation and Resistance Training to Preserve Muscle Mass and Attenuate Cancer Progression	NCT06112990	Metastatic Pros...	creatine monohy... Placebo Home-based, tel...	18 Years -	University of Utah
Creatine in Treating Patients With Cancer-Associated Weight Loss	NCT00081250	Anorexia Cachexia Unspecified Adu... Weight Changes	creatine monohy... placebo	18 Years -	Alliance for Clinical Trials in Oncology
Resistance Training +/- Creatine for Metastatic Prostate Cancer Patients	NCT03987217	Fatigue Metastatic Pros... Sedentary Lifes... Stage IV Prosta... Stage IVA Prost... Stage IVB Prost...	Creatine Monohy... Exercise Interv... Questionnaire A...	18 Years -	University of Utah
Creatine Supplementation and Resistance Training to Preserve Muscle Mass and Attenuate Cancer Progression	NCT06112990	Metastatic Pros...	creatine monohy... Placebo Home-based, tel...	18 Years -	University of Utah

Spots Global Cancer Trial Database for creatine monohydrate