Iyengar Yoga for Chemotherapy-induced Fatigue in Breast Cancer Patients

Breast Neoplasms Clinical Trial

— IFaB  

Official title:

Iyengar Yoga for Chemotherapy-induced Fatigue in Breast Cancer Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01686737
• Other study ID #: 2012210
• Status: Withdrawn
• Phase: N/A
• First received: September 12, 2012
• Last updated: February 4, 2013
• Start date: November 2012
• Est. completion date: July 2014

Study information

• Verified date: February 2013
• Source: Universität Duisburg-Essen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Fatigue

Intervention

Behavioral:
• Iyengar Yoga
12 weeks of Iyengar yoga 2 weekly sessions of 60 minutes
• Walking
12 weeks of walking 2 weekly sessions of 60 minutes

Locations

Country	Name	City	State
Germany	Klinik für Senologie / Brustzentrum, Kliniken Essen-Mitte	Essen
Germany	Brustzentrum Köln-Hohenlind, St. Elisabeth-Krankenhaus Köln-Hohenlind	Köln

Sponsors (1)

Lead Sponsor	Collaborator
Universität Duisburg-Essen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatigue	Multidimensional Fatigue Inventory	Week 12	No
Secondary	Fatigue	Multidimensional Fatigue Inventory	Week 36	No
Secondary	Health-related quality of life	Functional Assessment of Cancer Therapy - Breast	Week 12, week 36	No
Secondary	Depression and anxiety	Hospital Anxiety and Depression Scale	Week 12, week 36	No
Secondary	Sleep quality	Pittsburgh Sleep Quality Index	Week 12, week 36	No
Secondary	Perceived Stress	Perceived Stress Scale; Impact of Event Scale	Week 12, week 36	No
Secondary	Salivary Cortisol	Cortisol awakening response	Week 12, week 36	No
Secondary	Safety	Adverse events	Week 0-36	Yes