Creatine supplementation and resistance training to preserve muscle mass and attenuate cancer progression (CREATINE-52): a protocol for a double-blind randomized controlled trial.
Study Goal
The researchers aimed to determine whether creatine monohydrate supplementation combined with resistance training (Cr + RT) improves muscle mass, health outcomes, and markers of cancer progression in metastatic castration-sensitive prostate cancer (mCSPC) survivors receiving androgen deprivation therapy (ADT).
Results Summary
The study proposes that Cr + RT may address fatigue barriers and improve muscle mass and related health outcomes in mCSPC survivors, but results are pending as this is a planned trial (NCT06112990).
Population
200 mCSPC survivors receiving ADT.
Effective Dosage
Not specified (only mentions "an established creatine supplementation protocol").
Duration
52 weeks.
Interactions
None mentioned.
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
androgen deprivation therapy (ADT) | decrease | muscle mass | men with metastatic castration sensitive prostate cancer (mCSPC) | significant | facilitates significant declines | #1 |
androgen deprivation therapy (ADT) | increase | adverse health outcomes | men with metastatic castration sensitive prostate cancer (mCSPC) | - | facilitates | #2 |
resistance training (RT) | no change | muscle mass | non-metastatic CSPC survivors | - | preserves | #3 |
resistance training (RT) | increase | related health outcomes | non-metastatic CSPC survivors | - | improves | #4 |
Creatine monohydrate supplementation coupled with RT (Cr + RT) | decrease | fatigue barrier | CSPC survivors | - | may address | #5 |
Cr + RT | increase | muscle mass | cancer-free older adults and other clinical populations | - | improves | #6 |
Cr + RT | increase | related health outcomes | cancer-free older adults and other clinical populations | - | improves | #7 |
creatine supplementation | increase | cancer treatment | - | - | can complement | #8 |
Cr + RT | increase | survivorship needs | people with mCSPC | - | addresses gaps | #9 |
52-weeks of Cr + RT | neutral | muscle mass | - | - | test the effects | #10 |
52-weeks of Cr + RT | neutral | other related health outcomes | - | - | test the effects | #11 |
52-weeks of Cr + RT | neutral | markers of cancer progression | - | - | test the effects | #12 |
home-based, telehealth RT program | increase | RT in mCSPC survivors | mCSPC survivors | - | addresses a major facilitator | #13 |
multicomponent, patient-centered lifestyle strategy | no change | muscle mass | - | - | preserve | #14 |
multicomponent, patient-centered lifestyle strategy | increase | health outcomes | - | - | improve | #15 |
multicomponent, patient-centered lifestyle strategy | increase | cancer treatment | - | - | complement | #16 |
BACKGROUND: Muscle mass is important for metastatic prostate cancer survival and quality of life (QoL). The backbone of treatment for men with metastatic castration sensitive prostate cancer (mCSPC) is androgen deprivation therapy (ADT) with an androgen signaling inhibitor. ADT is an effective cancer treatment, but it facilitates significant declines in muscle mass and adverse health outcomes important to mCSPC survivors, such as fatigue, and reductions in physical function, independence, insulin sensitivity, and QoL. In non-metastatic CSPC survivors, resistance training (RT) preserves muscle mass and improves these related health outcomes, but the biggest barrier to RT in CSPC survivors of all stages is fatigue. Creatine monohydrate supplementation coupled with RT (Cr + RT) may address this barrier since creatine plays a critical role in energy metabolism. Cr + RT in cancer-free older adults and other clinical populations improves muscle mass and related health outcomes. Evidence also suggests that creatine supplementation can complement cancer treatment. Thus, Cr + RT is a strategy that addresses gaps in survivorship needs of people with mCSPC. The purpose of this parallel, double-blind randomized controlled trial is to test the effects of 52-weeks of Cr + RT compared with placebo (PLA) and RT (PLA + RT) on muscle mass, other related health outcomes, and markers of cancer progression. METHODS: We will carry out this trial with our team's established, effective, home-based, telehealth RT program in 200 mCSPC survivors receiving ADT, and evaluate outcomes at baseline, 24-, and 52-weeks. RT will occur twice weekly with elastic resistance bands, and an established creatine supplementation protocol will be used for supplementation delivery. Our approach addresses a major facilitator to RT in mCSPC survivors, a home-based RT program, while utilizing a supervised model for safety. DISCUSSION: Findings will improve delivery of comprehensive survivorship care by providing a multicomponent, patient-centered lifestyle strategy to preserve muscle mass, improve health outcomes, and complement cancer treatment (NCT06112990).