Patel Darpan I, Gonzalez Angela, Moon Crisann, Serra Monica, Bridges Preston Blake, Hughes Daniel, Clarke Geoffrey, Kilpela Lisa, Jiwani Rozmin, Musi Nicolas
Biobehavioral Research Laboratory, School of Nursing, University of Texas Health Science Center at San Antonio, San Antonio, TX, United States.
Barshop Institute for Longevity and Aging Studies, University of Texas Health Science Center at San Antonio, San Antonio, TX, United States.
JMIR Res Protoc. 2022 Apr 1;11(4):e26827. doi: 10.2196/26827.
In breast cancer survivors, chemotherapy-induced muscle loss has been shown to be attenuated with structured resistance exercise. Creatine supplementation can increase bioenergetics in skeletal muscle, which helps to improve overall strength and endurance and reduce muscular fatigue. Therefore, we hypothesize that adding creatinine supplementation to exercise training will accelerate improvements in strength, endurance, and bioenergetics in breast cancer survivors.
The primary objective is to determine the effects of combining creatine supplementation with exercise on modulating strength and physical function in breast cancer survivors by comparing these effects to those of exercise alone. The secondary objectives are to determine if creatine supplementation and exercise can increase the intramuscular storage of creatine and improve body composition by comparing this intervention to exercise alone.
We aim to test our hypothesis by conducting an open-label randomized controlled trial of 30 breast cancer survivors who have completed chemotherapy within 6 months of enrollment. Eligible participants will be equally randomized (1:1) to either a creatine and exercise group or an exercise-only group for this 12-week intervention. Individuals who are randomized to receive creatine will be initially dosed at 20 g per day for 7 days to boost the availability of creatine systemically. Thereafter, the dose will be reduced to 5 g per day for maintenance throughout the duration of the 12-week protocol. All participants will engage in 3 center-based exercise sessions, which will involve completing 3 sets of 8 to 12 repetitions on chest press, leg press, seated row, shoulder press, leg extension, and leg curl machines. The primary outcomes will include changes in strength, body composition, and physical function in breast cancer survivors. The secondary outcomes will be intramuscular concentrations of creatine and adenosine triphosphate in the vastus lateralis, midthigh cross-sectional area, and quality of life.
As of October 2021, a total of 9 patients have been enrolled into the study. No unexpected adverse events have been reported.
Creatine is being studied as a potential agent for improving strength, endurance, and bioenergetics in breast cancer survivors following chemotherapy. The findings from our trial may have future implications for supporting breast cancer survivors in reversing the muscle loss experienced during chemotherapy and improving their physical function and quality of life.
ClinicalTrials.gov NCT04207359; https://clinicaltrials.gov/ct2/show/NCT04207359.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/26827.
在乳腺癌幸存者中，结构化抗阻运动已被证明可减轻化疗引起的肌肉损失。补充肌酸可增加骨骼肌中的生物能量，有助于提高整体力量和耐力，并减少肌肉疲劳。因此，我们假设在运动训练中添加肌酸补充剂将加速乳腺癌幸存者在力量、耐力和生物能量方面的改善。
主要目的是通过将补充肌酸与运动相结合的效果与单独运动的效果进行比较，来确定其对调节乳腺癌幸存者力量和身体功能的影响。次要目的是通过将这种干预措施与单独运动进行比较，确定补充肌酸和运动是否能增加肌酸在肌肉内的储存并改善身体成分。
我们旨在通过对30名在入组后6个月内完成化疗的乳腺癌幸存者进行一项开放标签随机对照试验来检验我们的假设。符合条件的参与者将被等比例随机分配（1:1）到肌酸与运动组或仅运动组，进行为期12周的干预。被随机分配接受肌酸的个体最初每天服用20克，持续7天，以提高全身肌酸的可用性。此后，剂量将减至每天5克，在整个12周方案期间维持服用。所有参与者将参加3次基于中心的运动课程，包括在卧推、腿举、坐姿划船、肩推、腿部伸展和腿部弯举器械上完成3组，每组8至12次重复动作。主要结局将包括乳腺癌幸存者力量、身体成分和身体功能的变化。次要结局将是股外侧肌中肌酸和三磷酸腺苷的肌肉内浓度、大腿中部横截面积和生活质量。
截至2021年10月，共有9名患者入组该研究。未报告意外不良事件。
正在研究肌酸作为一种潜在药物，用于改善乳腺癌幸存者化疗后的力量、耐力和生物能量。我们试验的结果可能对支持乳腺癌幸存者逆转化疗期间经历的肌肉损失、改善其身体功能和生活质量具有未来意义。
ClinicalTrials.gov NCT04207359；https://clinicaltrials.gov/ct2/show/NCT04207359。
国际注册报告识别码（IRRID）：PRR1-10.2196/26827。
