NeoChemoPRT: A Randomized Study of Resistance Training and Post-Workout Protein to Improve Body Composition During Neoadjuvant Chemotherapy for Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Changes in muscle mass and fat mass (pounds) at completion of chemotherapy
研究概览
简要总结
In this study, the investigators hypothesize that a high dose of post-workout protein nutrition regimen focused on food quality and an observed exercise regimen utilizing high-load resistance training initiated during or after cancer treatment will improve body composition and functional capacity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 89 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 20-89 years
- •Women with a biopsy proven diagnosis of invasive carcinoma of the breast.
- •Women must undergo neoadjuvant chemotherapy for breast cancer treatment prior to surgery
- •Must be able to read and understand English and consent for themselves.
排除标准
- •Inability to get up and down off the ground or squat body weight
- •Inability to safely engage in group exercise sessions as deemed by study PI
- •Severe arthritic, joint, cardiovascular, musculoskeletal, or any other condition deemed by PI to be unsafe to engage in resistance training
- •Lactose intolerance
- •Cow's milk or whey protein allergy
- •Pregnant women
研究组 & 干预措施
20 grams of protein
Participants will be randomized (like flipping a coin) to a post-workout protein consisting of 20 grams of whey protein. The protein will be 100% cold processed and micro-filtered, non-GMO grass-fed whey protein isolate, soy and gluten free, unflavored, and unsweetened. This will include Irish Dairy, which is whey protein isolate and soy lecithin, and Raw GrassFed Whey, which is whey protein concentrate. Participants will not know which amount of protein they receive.
干预措施: Whey protein (20 grams) (Dietary Supplement)
60 grams of protein
Participants will be randomized (like flipping a coin) to a post-workout protein consisting of 60 grams of whey protein. The protein will be 100% cold processed and micro-filtered, non-GMO grass-fed whey protein isolate, soy and gluten free, unflavored, and unsweetened. This will include Irish Dairy, which is whey protein isolate and soy lecithin, and Raw GrassFed Whey, which is whey protein concentrate. Participants will not know which amount of protein they receive.
干预措施: Whey protein (60 grams) (Dietary Supplement)
结局指标
主要结局
Changes in muscle mass and fat mass (pounds) at completion of chemotherapy
时间窗: Baseline and at program completion (within 4 weeks of exercise completion).
次要结局
- Response to Chemotherapy Assed Via the Guidelines or the Response evaluation criteria in solid tumors (RECIST)(Chemotherapy response assessment is at program completion (within 4 weeks of exercise completion))
- Changes in EuroQol-5 Dimensions (EQ-5D) at completion of chemotherapy assessment(Baseline assessment (prior to program) and at exercise program completion (at 24 weeks).)
- Changes in Patient Health Questionnaire-9 (PHQ9) depression score at completion of chemotherapy assessment(Baseline assessment (prior to program) and at exercise program completion (at 24 weeks).)
- Changes in General Anxiety Disorder-7 (GAD7) anxiety score at completion of chemotherapy assessment(Baseline assessment (prior to program) and at exercise program completion (at 24 weeks).)
- Changes in activity levels via Godin Leisure-Time Exercise Questionnaire(Baseline assessment (prior to program) and at exercise program completion (at 24 weeks).)
- Changes in resting metabolic rate at completion of chemotherapy(Baseline and at program completion (within 4 weeks of exercise completion).)
- Changes in body composition at completion of chemotherapy, including fat-free mass in pounds.(Baseline and at program completion (within 4 weeks of exercise completion).)
- Changes in Y-Balance Test Scores at baseline and at completion of chemotherapy(Baseline and at program completion (within 4 weeks of exercise completion).)
- Changes in Functional Mobility Score at baseline and at completion of chemotherapy(Baseline and at program completion (within 4 weeks of exercise completion).)
- Changes in phase angle at completion of chemotherapy(At program completion (at 24 weeks))
研究者
Colin Champ, MD
Principal Investigator
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)