Yoga on QOL Physiological Distress&Fatigue, on Patients Affected by Breast Cancer in Adjuvant Radiotherapy

Study Overview
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Brief Summary
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The study aims to investigate, through serial measurements of some biomarkers, the potential mechanisms through which yoga impacts on QOL and fatigue.

Detailed Description
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The study aims to assess QoL, fatigue and physiological distress (cortisol and proinflammatory markers) with blood sampling on day 1,15 and last of radiotherapy, at 1-3-6 months after the end of radiotherapy. Patients with breast cancer who will undergo radiotherapy will be randomly assigned to the yoga group (YG) or the control group (CG). Patients in the YG will participate in 2 weekly yoga classes during the 5 weeks of radiation therapy. The classes will be coordinated with the treatment program and will be held in the vicinity of the radiation therapy center.

Official Title
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Monocentric, Randomized Clinical Trial About the Effect of Yoga Practice on QOL, Physiological Distress and Fatigue, on Patients Affected by Breast Cancer Undergoing Adjuvant Radiotherapy

Conditions
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Female Breast Cancer, Fatigue, Quality of Life, Physiological Stress, Radiotherapy; Complications

Intervention / Treatment
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* Behavioral: Yoga lessons


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women with stage 0-III breast cancer who have undergone adjuvant daily radiotherapy for 5 weeks in Istituto Scientifico Romagnolo per lo studio e la cura dei Tumori (IRST) Department of Radiation Oncology of Meldola. Exclusion Criteria: Patients with documented diagnosis of mental disorders (eg Schizophrenia) Patients with stage IV disease Patients with active or non-canalised deep vein thrombosis Patients not undergoing surgery for the basic oncological disease Patients with mobility problems (eg unable to get up from the chair) Patients who have practiced yoga or are practicing yoga in the 6 months before the cancer diagnosis. Patients diagnosed with lymphedema

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm Yoga (YG)<br>Patients assigned to the YG arm participate in yoga classes | Behavioral: Yoga lessons<br>* 2 weekly yoga classes during the 5 weeks of radiotherapy<br>|
| No Intervention: Arm control (CG)<br>Patients assigned to the CG arm will follow the normal course of radiotherapy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of physiological distress | Evaluation of the efficacy of yoga on reduction of physiological distress after the end of radiotherapy, measured via Short Form 36 (SF-36), Pittsburgh Sleep Quality Index (PSQI) and Quality of life questionnaire Core30 (QLQ-C30) questionnaire, and physiological functions (cortisol, blood sampling with proinflammatory markers evaluation) in stage 0-III breast cancer patients | up to 32 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of quality of life with yoga during and after radiotherapy | Assess whether yoga helps on increase Quality of Life (QOL) and decreasing fatigue via questionnaire Brief Fatigue Inventory (BFI). | up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Female Breast Cancer, Fatigue, Quality of Life, Physiological Stress, Radiotherapy; Complications