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Accepted for/Published in: JMIR Research Protocols

Date Submitted: Dec 29, 2020
Date Accepted: Oct 26, 2021

The final, peer-reviewed published version of this preprint can be found here:

Exercise and Creatine Supplementation to Augment the Adaptation of Exercise Training Among Breast Cancer Survivors Completing Chemotherapy: Protocol for an Open-label Randomized Controlled Trial (the THRIVE Study)

Patel D, Gonzalez A, Serra M, Roberts J, Burns A, Hughes D, Clarke G, Kilpela L, Jiwani R, Musi N

Exercise and Creatine Supplementation to Augment the Adaptation of Exercise Training Among Breast Cancer Survivors Completing Chemotherapy: Protocol for an Open-label Randomized Controlled Trial (the THRIVE Study)

JMIR Res Protoc 2022;11(4):e26827

DOI: 10.2196/26827

PMID: 35363152

PMCID: 9015753

An open-label randomized trial of exercise ± creatine supplementation to augment the adaptations of exercise training in breast cancer survivors completing chemotherapy: a study protocol for The THRIVE Study

  • Darpan Patel; 
  • Angela Gonzalez; 
  • Monica Serra; 
  • Joelle Roberts; 
  • Aisling Burns; 
  • Daniel Hughes; 
  • Geoffrey Clarke; 
  • Lisa Kilpela; 
  • Rozmin Jiwani; 
  • Nicolas Musi

ABSTRACT

Background:

In breast cancer (BCa) survivors, chemotherapy induced muscle loss has been shown to be reversed with structured resistance exercise. Creatine supplementation can increase bioenergetics in skeletal muscle, helping improve overall strength and endurance, and reduce muscular fatigue. Therefore, we hypothesize that adding creatine supplementation can accelerate improvements in strength, endurance, and bioenergetics in BCa survivors.

Objective:

PLEASE COMPLETE

Methods:

We aim to test this hypothesis by conducting an open-label, randomized controlled trial of 30 BCa survivors that have completed chemotherapy within 6 months of enrollment. Eligible participants will be equally randomized (1:1) to either a creatine + exercise group or an exercise only group for this 12-week intervention. Individuals randomized to receive creatine will be initially dosed at 20 g/day for 7 days to boost availability of creatine systemically. Thereafter, the dose will be reduced to 5 g/day for maintenance through the duration of the 12-week protocol. All participants will engage in three center-based exercise sessions completing 3 sets of 8-12 repetitions on the chest press, leg press, seated row, shoulder press, leg extension and leg curl machines. Primary outcomes include changes in strength, body composition, and physical function in BCa survivors. Secondary outcomes are intramuscular concentrations of creatine and ATP in the vastus lateralis, mid-thigh cross sectional area and quality of life.

Results:

As of October 2021, 9 patients have been enrolled into the study. No unexpected adverse events have been reported.

Conclusions:

Creatine is being studied as a potential agent to improve strength, endurance and bioenergetics in BCa survivors following chemotherapy. Findings from this trial may have future implications to supporting BCa survivors reverse the muscle loss experienced during chemotherapy and improve their physical function and quality of life.


 Citation

Please cite as:

Patel D, Gonzalez A, Serra M, Roberts J, Burns A, Hughes D, Clarke G, Kilpela L, Jiwani R, Musi N

Exercise and Creatine Supplementation to Augment the Adaptation of Exercise Training Among Breast Cancer Survivors Completing Chemotherapy: Protocol for an Open-label Randomized Controlled Trial (the THRIVE Study)

JMIR Res Protoc 2022;11(4):e26827

DOI: 10.2196/26827

PMID: 35363152

PMCID: 9015753

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