Grant Details
Grant Number: |
5R01CA281759-02 Interpret this number |
Primary Investigator: |
Coletta, Adriana |
Organization: |
University Of Utah |
Project Title: |
Creatine Supplementation and Resistance Training to Preserve Muscle Mass and Attenuate Cancer Progression: a Double-Blind Randomized Controlled Trial |
Fiscal Year: |
2024 |
Abstract
ABSTRACT
The incidence of metastatic prostate cancer has increased 3% per year since 2012, and the survival rate is
only 29%. Muscle mass is important for metastatic prostate cancer survival and quality of life (QoL). Androgen
deprivation therapy (ADT) with an androgen signaling inhibitor is the backbone of treatment for men with
metastatic castration sensitive prostate cancer (mCSPC). But the androgen blockade diminishes muscle mass
and contributes to adverse health outcomes critical to mCSPC survivors, such as fatigue, and declines in
physical function, independence, insulin sensitivity, and QoL. Resistance training (RT) can preserve muscle
mass and improve health outcomes in non-metastatic CSPC survivors receiving ADT. The addition of creatine
monohydrate supplementation to an RT program amplifies the effects of RT in cancer-free older adults and
other clinical populations. Evidence also suggests that creatine supplementation can complement cancer
treatment. Thus, creatine monohydrate supplementation with RT (Cr+RT) is a strategy that addresses an
important knowledge gap pertaining to survivorship needs of mCSPC survivors. We hypothesize that Cr+RT
will preserve muscle mass and improve health outcomes greater than RT alone, and that creatine use will lead
to favorable changes in markers of cancer progression in mCSPC survivors receiving ADT. Here we propose a
parallel, double-blind randomized controlled trial to test the effects of 52-weeks of Cr+RT compared with
placebo (PLA) and RT (PLA+RT) with our team's established, effective, home-based, telehealth RT program
in 200 mCSPC survivors receiving ADT. We will evaluate muscle mass (primary outcome), health outcomes
(fatigue, physical function, independence, insulin sensitivity, QoL), and markers or cancer progression (PSA,
cfDNA) at baseline, 24-, and 52-weeks. RT will be carried out twice weekly with elastic resistance bands, and
we will utilize an established creatine supplementation protocol for creatine and PLA delivery. Our trial builds
on work done by our investigative team, and addresses an evidence gap listed in this RFA (CA-22-027:
Research to Understand and Address Survivorship Needs of Individuals Living with Advanced Cancer) re:
“Interventional research to determine the best ways to improve the quality of care and QoL for individuals living
with likely incurable cancer”, identified gaps in the literature, and unmet needs of mCSPC survivors. Our
approach addresses a major facilitator to RT in mCSPC survivors, a home-based RT program, while utilizing a
supervised model for safety. Our approach can be translated on a large-scale as it can be adopted by
institutions who use an established telemedicine system, and creatine monohydrate supplementation and
elastic resistance bands are inexpensive and widely available. These findings will improve delivery of
comprehensive survivorship care by providing a multicomponent, patient-centered lifestyle strategy to preserve
muscle mass, improve health outcomes and QoL, and complement cancer treatment.
Publications
Creatine supplementation and resistance training to preserve muscle mass and attenuate cancer progression (CREATINE-52): a protocol for a double-blind randomized controlled trial.
Authors: Coletta A.M.
, Simon L.H.
, Maslana K.
, Taylor S.
, Larson K.
, Hansen P.A.
, Thomas V.M.
, Ulrich C.M.
, Kohli M.
, Chipman J.
, et al.
.
Source: Bmc Cancer, 2024-04-18 00:00:00.0; 24(1), p. 493.
EPub date: 2024-04-18 00:00:00.0.
PMID: 38637770
Related Citations