Iyengar Yoga for Chemotherapy-induced Fatigue in Breast Cancer Patients

Study Overview
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Brief Summary
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Breast cancer is the most frequent cancer in women and is associated with profound restrictions of health-related quality of life and psychosocial health. More than three-quarters of women with breast cancer suffer from fatigue during cancer treatment. While exercise interventions can improve fatigue in breast cancer patients, many patients request complementary treatment approaches. Therefore, this study investigates the effects of yoga in women with breast cancer compared to aerobic exercise and usual care. It is hypothesized that yoga is more effective than usual care and equally effective as aerobic exercise.

Official Title
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Iyengar Yoga for Chemotherapy-induced Fatigue in Breast Cancer Patients

Conditions
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Breast Neoplasms, Fatigue

Intervention / Treatment
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* Behavioral: Iyengar Yoga
* Behavioral: Walking


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: non-metastatic invasive breast cancer currently receiving adjuvant chemotherapy moderate to severe chemotherapy-induced fatigue physical and cognitive capacity to participate in yoga or walking Exclusion Criteria: diagnosed and pharmacologically treated psychiatric disorder except depressive adaptation disorder as a reaction to cancer diagnosis ECOG status > 1 prior malignancy with a disease-free survival < 10 years except curatively treated basalioma of the skin and carcinoma in situ of the cervix prior ductal carcinoma in situ (DCIS) ot the breast pregnancy or breastfeeding regular practice of yoga or walking during the past 12 months

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yoga<br>Iyengar Yoga 12 weeks of Iyengar yoga 2 weekly sessions of 60 minutes | Behavioral: Iyengar Yoga<br>* 12 weeks of Iyengar yoga 2 weekly sessions of 60 minutes<br>|
| Active Comparator: Aerobic exercise<br>Walking 12 weeks of walking 2 weekly sessions of 60 minutes | Behavioral: Walking<br>* 12 weeks of walking 2 weekly sessions of 60 minutes<br>|
| No Intervention: Usual Care<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue | Multidimensional Fatigue Inventory | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue | Multidimensional Fatigue Inventory | Week 36 | 
| Health-related quality of life | Functional Assessment of Cancer Therapy - Breast | Week 12, week 36 | 
| Depression and anxiety | Hospital Anxiety and Depression Scale | Week 12, week 36 | 
| Sleep quality | Pittsburgh Sleep Quality Index | Week 12, week 36 | 
| Perceived Stress | Perceived Stress Scale Impact of Event Scale | Week 12, week 36 | 
| Salivary Cortisol | Cortisol awakening response | Week 12, week 36 | 
| Safety | Adverse events | Week 0-36 |