Iyengar Yoga for Chemotherapy-induced Fatigue in Breast Cancer Patients

Not Applicable

Withdrawn

• Conditions: Breast Neoplasms; Fatigue
• Interventions: Behavioral: Iyengar Yoga; Behavioral: Walking

• Registration Number: NCT01686737
• Lead Sponsor: Universität Duisburg-Essen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-09-12
• Study First Submitted QC: 2012-09-12
• Study First Posted: 2012-09-18
• Study Start: 2012-11
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-04
• Last Update Posted: 2013-02-05
• Primary Completion: 2014-01
• Study Completion: 2014-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Yoga	Iyengar Yoga	Iyengar Yoga * 12 weeks of Iyengar yoga * 2 weekly sessions of 60 minutes
Aerobic exercise	Walking	Walking * 12 weeks of walking * 2 weekly sessions of 60 minutes

Primary Outcome Measures

Name	Time	Method
Fatigue	Week 12	Multidimensional Fatigue Inventory

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Klinik für Senologie / Brustzentrum, Kliniken Essen-Mitte; 🇩🇪 Essen, Germany

Brustzentrum Köln-Hohenlind, St. Elisabeth-Krankenhaus Köln-Hohenlind; 🇩🇪 Köln, Germany