An Open-label Randomized Trial of Exercise ± Creatine Supplementation to Augment the Adaptations of Exercise Training in Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in physical functional capacity in breast cancer survivors
研究概览
简要总结
The study's purpose is to evaluate whether creatine supplementation can help breast cancer survivors respond quicker to exercise by improving strength, endurance, and body composition. We are seeking to compare information collected from healthy woman of the same age who have never had breast cancer to those participants who have had breast cancer and undergone chemotherapy treatment.
详细描述
The primary objective of this study is to determine the effects of creatine supplementation in modulating strength and physical function in breast cancer survivors that have recently completed chemotherapy. The primary objective is to determine the effects of creatine in modulating strength and physical function in cancer survivors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •(Breast Cancer Group)
- •Age 18-75 years of age
- •Diagnosis of breast cancer requiring chemotherapy
- •Recent (within 6 months) completion of chemotherapy
- •Willing to attend 3 virtual-based exercise sessions per week
- •Able to take oral medications
- •Participant is willing and able to provide consent to participating in the study
- •Serum creatinine ≤ 1.5 x ULN or Estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration equation.
排除标准
- •(Breast Cancer Group)
- •Physical indications where performing exercise may be limited and/or contraindicated
- •Poorly controlled hypertension (blood pressure > 160/95mmHg)
- •Current tobacco use (within 6 months)
- •Anabolic steroids use
- •Pitting edema greater than 2+
- •Currently undergoing chemotherapy treatment for cancer
- •History of moderate-severe heart disease (New York Heart Classification greater than grade II) or pulmonary disease (dyspnea on exertion upon climbing one flight of stairs or less; abnormal breath sounds on auscultation)
- •Pregnant or plan to become pregnant during the study
- •Recent (within one month) or anticipated treatment with corticosteroids (except for short term use during the time of chemotherapy), or other appetite stimulants
- •Serum creatinine > 1.5 x ULN or Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration equation
- •Currently taking creatine supplements
- •Lack of availability to a smartphone and/or internet
- •Inclusion Criteria (Healthy Age-matched Control Group)
- •Age 18-75 years of age
- •Have never been diagnosed with cancer
- •Willing to provide consent to participate in this study
- •Exclusion Criteria (Healthy Age-matched Control Group)
- •Physical indications where performing exercise may be limited and/or contraindicated
- •Poorly controlled hypertension (blood pressure > 160/95mmHg)
- •Current tobacco use (within 6 months)
- •Anabolic steroids use
- •Pitting edema greater than 2+
- •History of cancer diagnosis
- •History of moderate-severe heart disease (New York Heart Classification greater than grade II) or pulmonary disease (dyspnea on exertion upon climbing one flight of stairs or less; abnormal breath sounds on auscultation)
- •Pregnant or currently taking prescribed medication to prepare for pregnancy (i.e.
- •hormonal therapy for IVF)
- •Recent (within one month) treatment with corticosteroids
- •Recent (within one month) use of appetite stimulants or appetite suppressants
- •Serum creatinine > 1.5 x ULN or Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration equation
- •Diagnosed Bipolar Disorder or MDQ score indicative of bipolar disorder or Neurological disorders
- •Uncontrolled diabetes (A1c of 6.5% or higher)
- •Currently taking creatine supplements
- •Lack of availability to a smartphone and/or internet
研究组 & 干预措施
Age-Matched Control Group
Women who have never been diagnosed with cancer.
Non-Creatine Supplement Group
Participants will engage in three center-based exercise sessions each week for 12 weeks; each session lasting roughly 1-hour. Participants will be given a Fitbit (electronic watch that measures steps or heart rate) as well to track heart rate and monitor activity throughout the study.
Creatine Supplement Group
Those randomized to receive creatine (experimental group) 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. Participants will engage in three center-based exercise sessions each week for 12 weeks; each session lasting roughly 1-hour. Participants will be given a fitbit (electronic watch that measures steps or heart rate) as well to track heart rate and monitor activity throughout the study.
干预措施: Creatine (Dietary Supplement)
结局指标
主要结局
Change in physical functional capacity in breast cancer survivors
时间窗: baseline and 12 weeks
Determine the change in strength in breast cancer survivors by comparing pre and post measurements of the six minute walk test.
Change in strength in breast cancer survivors
时间窗: baseline and 12 weeks
Determine the change in strength in breast cancer survivors by comparing pre and post measurements of strength measurement tools including 1RM/10RM/Biodex evaluations.
次要结局
- Change intramuscular storage of creatine(baseline and 12 weeks)
- Change in the return of strength for breast cancer survivors with creatine + exercise(12 weeks)
- Change in body composition in cancer survivors(baseline and 12 weeks)