Randomized Controlled Evaluating the Role of Exercise in Women Undergoing Treatment for Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 850
- 主要终点
- Disease-free survival
研究概览
简要总结
Randomized controlled trial to evaluate the impact of yoga on QOL is also powered to evaluate the impact of yoga on survival. Study involves various phases of yoga(divided in three phases: Phase I/II/III) during treatment and survivorship, with a comparative analysis of different time points and the response to yoga, which will help integrating yoga as a complementary modality. Also, this study will help identify the long term and short term effects of this therapy in breast cancer patients and survivors.
One of the main differences between yoga and other forms of physical activity is that yoga exercises oppose violent muscle movement and is designed to counteract fatigue through relaxation and breathing. 6 monthly Follow Up will be for 5 years followed by yearly follow up.
详细描述
Women with breast cancer are constantly exploring measures in addition to ongoing conventional therapy to relieve disease related symptoms, minimize side effects associated with conventional treatment, reduce their risk of recurrence and enhance their prospects for survival. Breast cancer survival rates have considerably improved over the years with the advent of new therapeutic measures and early detection. However its treatment sequelae are associated with significant changes in quality of life (QOL) and well being. Fatigue is one of the most prevalent QOL concerns, affecting 30% to 70% of breast cancer survivors.
Yoga is based on the practice of physical postures, breathing techniques and meditation. Philosophically, it aims at increasing the body's ability to master the mind with the goal of spiritual awareness and connection. A randomized trial of yoga in women with breast cancer undergoing radiation therapy demonstrated an improvement in impact of events scale at 3 months suggesting that the more intrusive thoughts at 1 month the greater the finding of meaning in cancer by 3 months.
- This is the first randomized controlled trial of this magnitude (850 women), which in addition to testing the impact of yoga on QOL is also powered to evaluate the impact of yoga on survival
- This is a longitudinal study measuring various phases of yoga during treatment and survivorship, with a comparative analysis of different time points and the response to yoga , which will help integrating yoga as a complementary modality
- Also, this study will help identify the long term and short term effects of this therapy in breast cancer patients and survivors
- The exercises are carefully designed keeping the phase of treatment or recovery of the breast cancer patient/survivor in focus.
- Chronic ailments have also been kept in mind (eg: which impede mobility or flexibility ie: spondylosis)
- One of the main differences between yoga and other forms of physical activity is that yoga exercises oppose violent muscle movement and is designed to counteract fatigue through relaxation and breathing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with unilateral breast cancer
- •Age 18-65 years
排除标准
- •Metastatic breast cancer
- •Pregnant Women
- •Women with physical limitations to perform exercises
- •Previous history of cancer
研究组 & 干预措施
Exercise I
Yogic and Routine Exercises (referred to as exercise I) Phase I: 1-7 days (Minimum attendance 4 days), Phase II: 8 - 14 days (Minimum attendance 4 days), Phase III: at 6-9 months or 12-15 months 1 year up gradation of exercises at 6-9 month or 12-15 months 1 year (Depending upon compliance to phase II exercises) Objective assessment at baseline, 14 days, 6-9, 12-15, 18-21, 36-39 and 54-57 months Exercise evaluation will be done at 6-9, 12-15, 30-33, 48-51 and 66-69 months
干预措施: Yoga Exercises (Other)
Exercise II
Objective assessment at baseline, 14 days, 6-9, 12-15, 18-21, 36-39 and 54-57 months
干预措施: Yoga Exercises (Other)
结局指标
主要结局
Disease-free survival
时间窗: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months.
To assess the effect of yoga on disease free survival in women breast cancer.
次要结局
- Assess the impact of Yoga on inflammatory cytokines and cell free chromatin(From randomization to 12 months)
- Pain assessment(from randomization to 60 months)
- Quality of life assessment(from randomization to 60 months)
- Improvements in Lung Function(The FEV1/ FVC ratio and the value will be checked, if the value is within 80% to 120%, it will be considered as normal (95 percent confidence interval). From randomization until 12 months.)
- Improvements in Overall survival(from the date of randomization to the date of death or censored at the date of last follow up for the patients who are alive or lost to follow up, until 60 months)
研究者
Nita Sukumar Nair
Professor and Surgeon (Breast Surgical Oncology Services)
Tata Memorial Centre