Reducing Metabolic Dysregulation in Obese Latina Breast Cancer Survivors Using Physical Activity: The ROSA Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Change in Metabolic Dysregulation (MetD) After Completion of Phase 1 Progressive Combine Training (PCT) -Insulin Resistance
研究概览
简要总结
This study is about testing whether exercise will improve fitness and lessen risk factors related to heart disease, diabetes, and obesity in Latina breast cancer survivors.
详细描述
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied. The purpose of this research is to determine whether a 16-week exercise program will improve fitness and lessen risk factors related to coronary artery disease, stroke, and type 2 diabetes in patients who have breast cancer and is sustainable for a Latina population to incorporate into their lifestyle following completion of the 16-week intervention.
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
Participants in this study will be randomly assigned into one of the study groups: Progressive Combine Training (PCT) or Attention Control.
- Progressive combined training (PCT) will be performed in 2 phases:
- supervised 16-week resistance and cardiovascular exercise at a local YMCA (months 1-4) or remotely at home via Zoom.
- unsupervised 16-week resistance and cardiovascular exercise at a local YMCA (months 5-8) or remotely at home with weekly check-ins with trainer.
- Attention Control Group: 51 weeks home-based stretching
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women newly diagnosed (Stage I-III) breast cancer.
- •Over the age of 18 years; children under the age of 18 will be excluded due to rarity of disease
- •The effects of exercise on the developing fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation. Should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately.
- •Are centrally obese with the following criteria[84] (determined by study team at eligibility screening): BMI >30 kg/m2 (calculated using height and weight; an upper limit BMI will not be set; we will rely on obtaining physicians' clearance to assess full eligibility) or body fat >30% (estimated by bioelectrical impedance), and waist circumference >35 in.
- •Have undergone a lumpectomy or mastectomy.
- •Have received and completed neoadjuvant or adjuvant chemotherapy and/or radiation therapy within the past 12 months.
- •Speak English or Spanish
- •Self-identify as Latina
- •Is in breast cancer remission with no detectable disease present
- •Able to initiate a supervised exercise program (free from any cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity)
- •Free from history of chronic disease including uncontrolled diabetes, hypertension or thyroid disease
- •Have not experienced a weight reduction ≥10% within the past 6 months
- •Currently participate in less than 60 minutes of structured exercise/week
- •No planned reconstructive surgery with flap repair during trial and follow-up period
- •May use adjuvant endocrine therapy if use will be continued for duration of study intervention
- •Does not smoke (no smoking during previous 12 months)
- •Willing to travel to Dana-Farber Cancer Institute for necessary data collection
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Patients should not have any uncontrolled illness including ongoing or active infection, uncontrolled diabetes, hypertension or thyroid disease; women using Metformin to manage diabetes will be excluded from the trial
- •Patients may not be receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy
- •Patients with other active malignancies are ineligible for this study.
- •Patients with metastatic disease
- •Is not centrally obese as defined above
- •Has not completed surgery, chemotherapy, or radiation treatment associated with their diagnosis
- •History of any musculoskeletal, cardiorespiratory or neurological diseases that preclude the participation in exercise
- •Participates in more than 60 minutes of structured exercise/week
- •Is planning reconstructive surgery with flap repair during trial and follow-up period
- •Currently smokes
- •Is unable to travel to Dana-Farber Cancer Institute and/or exercise facility for necessary data collection
- •Weight reduction ≥ 10% within past 6 months
- •Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.
研究组 & 干预措施
Progressive combine training (PCT)
Participants will be randomly assigned to Progressive combine training (PCT) group.
Participants will have two (2) baseline tests, then begin a two phase PCT program.
- Phase 1: Supervised 16-week resistance and cardiovascular exercise at a local YMCA (months 1-4) or remotely at home via Zoom
- Participants will receive midpoint testing, approximately week 8.
- Phase 2: Unsupervised 16-week resistance and cardiovascular exercise at a local YMCA (months 5-8) or remotely at home
- Participants will receive midpoint testing, approximately two months into phase 2.
After the two (2) 16-week phases, participants will be followed for 4 months.
干预措施: Progressive combine training (PCT) (Behavioral)
Attention Control (AC)
Participants will be randomly assigned to Attention Control (AC) group.
Two (2) baseline tests will be performed prior to starting the program. Participants will perform 12 months of home-based stretching and have a 1x test performed during months 2, 4, 6, 8 and 10. Two (2) tests will be performed in month 12.
干预措施: Attention Control (AC) (Behavioral)
结局指标
主要结局
Change in Metabolic Dysregulation (MetD) After Completion of Phase 1 Progressive Combine Training (PCT) -Insulin Resistance
时间窗: 16 weeks
Changes from baseline in insulin resistance (IR) measured by Homeostasis Model Assessment (HOMA)
Change in Metabolic Dysregulation (MetD) After Completion of Phase 1 Progressive Combine Training (PCT) -metabolic syndrome (MSY)
时间窗: 16 weeks
Frequency of metabolic syndrome (MSY) diagnosed by criteria accepted by the American Heart Association (AHA)
Change in Metabolic Dysregulation (MetD) After Completion of Phase 1 Progressive Combine Training (PCT) -Visceral adiposity
时间窗: 16 weeks
Changes from baseline in visceral adiposity (VA) measured by dual-energy X-ray absorptiometry (DXA), waist to hip ratio (WHR) and bioelectrical impedance technology (BIA)
次要结局
- Compare Metabolic Dysregulation (MetD) in Progressive Combine Training (PCT) and Attention (AC) groups - Visceral adiposity(16 weeks)
- Compare Metabolic Dysregulation (MetD) in Progressive Combine Training (PCT) and Attention (AC) groups - metabolic syndrome (MSY)(16 weeks)
- Metabolic Dysregulation (MetD) Status During 4 month follow up period - insulin resistance (IR)(16 weeks)
- Metabolic Dysregulation (MetD) Status During 4 month follow up period - Visceral adiposity (VA)(16 weeks)
- Compare Metabolic Dysregulation (MetD) in Progressive Combine Training (PCT) and Attention (AC) groups -Insulin Resistance(16 weeks)
- Metabolic Dysregulation (MetD) Status During 4 month follow up period - metabolic syndrome (MSY)(16 weeks)
研究者
Christina Dieli-Conwright, PhD
Principal Investigator
Dana-Farber Cancer Institute