Iyengar Yoga for Chemotherapy-induced Fatigue in Breast Cancer Patients

NCT01686737 | Withdrawn

• 1 other identifier: 2012210
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Neoplasms; Fatigue

Outcome Measures

Primary Outcomes (1)

• Fatigue

  Multidimensional Fatigue Inventory

  Week 12

Secondary Outcomes (7)

• Fatigue

  Week 36

• Health-related quality of life

  Week 12, week 36

• Depression and anxiety

  Week 12, week 36

• Sleep quality

  Week 12, week 36

• Perceived Stress

  Week 12, week 36

Study Arms (3)

Yoga

EXPERIMENTAL

Iyengar Yoga * 12 weeks of Iyengar yoga * 2 weekly sessions of 60 minutes

Behavioral: Iyengar Yoga

Aerobic exercise

ACTIVE COMPARATOR

Walking * 12 weeks of walking * 2 weekly sessions of 60 minutes

Behavioral: Walking

Usual Care

NO INTERVENTION

Interventions

Iyengar Yoga BEHAVIORAL

* 12 weeks of Iyengar yoga * 2 weekly sessions of 60 minutes

Yoga

Walking BEHAVIORAL

* 12 weeks of walking * 2 weekly sessions of 60 minutes

Aerobic exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universität Duisburg-Essen: lead

Study Sites (2)

Brustzentrum Köln-Hohenlind, St. Elisabeth-Krankenhaus Köln-Hohenlind

Cologne, 50935, Germany

Location

Klinik für Senologie / Brustzentrum, Kliniken Essen-Mitte

Essen, 45136, Germany

Location

MeSH Terms

Conditions

Breast Neoplasms; Fatigue

Interventions

Walking

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Motor Activity

Study Officials

• Holger Cramer, PhD

  University of Duisburg-Essen, Chair of Complementary and Integrative Medicine

  PRINCIPAL INVESTIGATOR

• Gustav J. Dobos, MD

  University of Duisburg-Essen, Chair of Complementary and Integrative Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral fellow

Study Record Dates

• First Submitted: September 12, 2012
• First Posted: September 18, 2012
• Study Start: November 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: July 1, 2014
• Last Updated: February 5, 2013

Record last verified: 2013-02

Locations

DE (2)