NCT04720209进行中（未招募）不适用
Taking AIM at Breast Cancer: Targeting Adiposity and Inflammation With Movement to Improve Prognosis in Breast Cancer Survivors
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 102
- 试验地点
- 4
- 主要终点
- Decrease in adipose tissue levels of inflammation.
研究概览
简要总结
The purpose of this research is to determine whether a 16-week exercise program for individuals with breast cancer and have completed treatment (i.e., surgery, chemotherapy, or radiation) for breast cancer will decrease inflammation in fat tissue.
详细描述
This study is about using different types of exercise to reduce inflammation in fat tissue in an effort to minimize the risk of cancer recurrence related to being overweight or obese. The investigators hope to learn whether participating in a specific exercise program can cause inflammation in the fat tissue to decrease.
The names of the study interventions involved in this study are:
- Circuit-style aerobic and resistance exercise (CARE)
- Traditional aerobic and resistance exercise (TARE)
The research study procedures include screening for eligibility, and study treatment including evaluations and follow up visits.
The study treatment will be for 4 months and participants will followed for 8 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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 diagnosed with breast cancer (all stages excluding stage IV), low grade disease positive for estrogen and progesterone receptors
- •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 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. Patients must undergo a pregnancy test via urine strip that will be covered and provided by the PI. Urine strips will be utilized over bloodwork for cost effectiveness. Urine tests will be distributed once before DEXA scans.
- •Are centrally obese with the following criteria[57] (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.
- •If cancer treatment included neoadjuvant or adjuvant chemotherapy and/or radiation therapy, participant must have received and completed treatment.
- •Speak English
- •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, trastuzumab or pertuzumab 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
- •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
- •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 the exercise facilities
- •Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
结局指标
主要结局
Decrease in adipose tissue levels of inflammation.
时间窗: 16 weeks
Adipose tissue inflammation will be assessed by measuring: leptin, adiponectin, IL-6 and IL-8
次要结局
- 4-month CARE intervention on sarcopenic obesity.(16 Weeks)
研究者
Christina Dieli-Conwright, PhD
Principal Investigator
Dana-Farber Cancer Institute
研究点 (4)
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