Effects of Yoga in the treatment of Breast Cancer: a randomized clinical trial

INTERVENTION: This is a randomized controlled, parallel, two‐arm clinical study. The experimental group will be 15 women undergoing treatment for stage I to III breast cancer who will undergo a Yoga program twice a week for eight weeks lasting 60 minutes each session. The control group will be 15 women who will participate in counseling sessions for a healthier life once a week for eight weeks, each session lasting 60 minutes. The randomization of participants will be processed by a researcher not involved in other research procedures and will occur in a 1:1 ratio. Blocks with even numbers of four or eight participants will be generated, with the size of the block planned to consider the interventions (Yoga or health education). The group consultation to be allocated to each participant will be carried out on a subject‐by‐subject basis by the same researcher (not involved in the assessments or interventions). The allocation of participants to one of the groups will be according to the order in which the pre‐intervention measures were completed. In this study, cancer‐related fatigue is the primary outcome. Secondary outcomes will be considered functional capacity, quality of life and pain perception and additional outcomes will be adherence and adverse events. Assessments of cancer‐related fatigue, functional capacity and quality of life will be carried out pre and post‐intervention. The intervention period will be eight weeks and participants will be assessed before (week 0) and after the intervention (week 9), starting 72 hours after the last session. The tests will be carried out on alternate days so that participants are spared from fatigue. The pre and post evaluations of each individual will be carried out by the same trained evaluator in a blinded manner. Both assessments and i CONDITION: Malignant neoplasm of breast PRIMARY OUTCOME: It is expected to find a difference in cancer‐related fatigue levels in the intervention group, assessed by a fatigue scale applied by an evaluator. Data collected pre‐intervention (week 0) and post‐intervention (week 9). SECONDARY OUTCOME: It is expected to observe an improvement in pain levels assessed through a questionnaire administered by an evaluator. Data collected pre‐intervention (week 0) and post‐intervention (week 9). It is expected to observe an increase in functional capacity in the intervention group, assessed through a battery of tests applied by an evaluator. Data collected pre‐intervention (week 0) and post‐intervention (week 9). It is expected to observe an increase in quality of life, assessed through a questionnaire administered by an evaluator. Data collected pre‐intervention (week 0) and post‐intervention (week 9). t is expected to observe an increase in the level of physical activity in the leisure domain. Data collected pre‐intervention (week 0) and post‐intervention (week 9). INCLUSION CRITERIA: To participate in the sample, participants must meet the following eligibility criteria: age equal to or greater than 18 years; diagnosis of stage I‐III breast cancer; undergoing chemotherapy or radiotherapy; if you are undergoing radiotherapy treatment, you have already completed chemotherapy treatment; not present a history of severe cardiovascular disease that prevents the practice of physical exercise (with the exception of arterial hypertension controlled by medication); no active metastatic or locoregional disease; not have any severe physical or psychiatric condition that makes it impossible to exercise and not be engaged in regular exercise programs for more than 75 minutes a week.