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Randomized Controlled Trial Evaluating the Role of Exercise in Women Undergoing Treatment for Breast Cancer

Tata Memorial Hospital · 2010
ClinicalTrials.gov · Datasets · License: Public Domain · 2010
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TITLE: Randomized Controlled Evaluating the Role of Exercise in Women Undergoing Treatment for Breast Cancer Yoga and Quality of life: 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. Randomized studies have demonstrated evidence of yoga improving the emotional well being of women with breast cancer and improving their distressed mood, thus providing a buffering effect on QOL. The main beneficial effects demonstrated are on social functioning. Among patients not receiving chemotherapy, yoga appears to enhance emotional well-being and mood and may serve to buffer deterioration in both overall and specific domains of QOL. EVALUATION TOOLS- European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire (EORTC QLQ-C30 \& BR-23) Brief Fatigue Inventory VAS (Pain score) Spirituality Questionnaire Pulmonary function test Objective assessment STUDY ENDPOINTS- Primary end points- Disease free survival Secondary end points- Quality of life \& Improvements in overall survival STUDY DESIGN TREATMENT PLAN - All newly diagnosed cases with stage I-III of breast cancer who present to Tata Memorial Hospital will be randomly assigned to perform either a set of 'Yogic and Routine Exercises (referred to as exercise I) or Routine Exercises'(referred to as exercise II)./ Patients will begin the exercises within a week of starting treatment. Both arms of the study will receive a training session one hour per day for the first week, during which they will be instructed to practice daily and maintain a daily log. The other evaluation
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