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Iyengar Yoga for Chemotherapy-induced Fatigue in Breast Cancer Patients (IFaB)

Primary Purpose

Breast Neoplasms, Fatigue

Status
Withdrawn
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Iyengar Yoga
Walking
Sponsored by
Universität Duisburg-Essen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Klinik für Senologie / Brustzentrum, Kliniken Essen-Mitte
  • Brustzentrum Köln-Hohenlind, St. Elisabeth-Krankenhaus Köln-Hohenlind

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Yoga

Aerobic exercise

Usual Care

Arm Description

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

Walking 12 weeks of walking 2 weekly sessions of 60 minutes

Outcomes

Primary Outcome Measures

Fatigue
Multidimensional Fatigue Inventory

Secondary Outcome Measures

Fatigue
Multidimensional Fatigue Inventory
Health-related quality of life
Functional Assessment of Cancer Therapy - Breast
Depression and anxiety
Hospital Anxiety and Depression Scale
Sleep quality
Pittsburgh Sleep Quality Index
Perceived Stress
Perceived Stress Scale Impact of Event Scale
Salivary Cortisol
Cortisol awakening response
Safety
Adverse events

Full Information

First Posted
September 12, 2012
Last Updated
February 4, 2013
Sponsor
Universität Duisburg-Essen
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1. Study Identification

Unique Protocol Identification Number
NCT01686737
Brief Title
Iyengar Yoga for Chemotherapy-induced Fatigue in Breast Cancer Patients
Acronym
IFaB
Official Title
Iyengar Yoga for Chemotherapy-induced Fatigue in Breast Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Withdrawn
Why Stopped
Recruitment problems
Study Start Date
November 2012 (undefined)
Primary Completion Date
January 2014 (Anticipated)
Study Completion Date
July 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universität Duisburg-Essen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms, Fatigue

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Yoga
Arm Type
Experimental
Arm Description
Iyengar Yoga 12 weeks of Iyengar yoga 2 weekly sessions of 60 minutes
Arm Title
Aerobic exercise
Arm Type
Active Comparator
Arm Description
Walking 12 weeks of walking 2 weekly sessions of 60 minutes
Arm Title
Usual Care
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Iyengar Yoga
Intervention Description
12 weeks of Iyengar yoga 2 weekly sessions of 60 minutes
Intervention Type
Behavioral
Intervention Name(s)
Walking
Intervention Description
12 weeks of walking 2 weekly sessions of 60 minutes
Primary Outcome Measure Information:
Title
Fatigue
Description
Multidimensional Fatigue Inventory
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Fatigue
Description
Multidimensional Fatigue Inventory
Time Frame
Week 36
Title
Health-related quality of life
Description
Functional Assessment of Cancer Therapy - Breast
Time Frame
Week 12, week 36
Title
Depression and anxiety
Description
Hospital Anxiety and Depression Scale
Time Frame
Week 12, week 36
Title
Sleep quality
Description
Pittsburgh Sleep Quality Index
Time Frame
Week 12, week 36
Title
Perceived Stress
Description
Perceived Stress Scale Impact of Event Scale
Time Frame
Week 12, week 36
Title
Salivary Cortisol
Description
Cortisol awakening response
Time Frame
Week 12, week 36
Title
Safety
Description
Adverse events
Time Frame
Week 0-36

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Holger Cramer, PhD
Organizational Affiliation
University of Duisburg-Essen, Chair of Complementary and Integrative Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gustav J. Dobos, MD
Organizational Affiliation
University of Duisburg-Essen, Chair of Complementary and Integrative Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Klinik für Senologie / Brustzentrum, Kliniken Essen-Mitte
City
Essen
ZIP/Postal Code
45136
Country
Germany
Facility Name
Brustzentrum Köln-Hohenlind, St. Elisabeth-Krankenhaus Köln-Hohenlind
City
Köln
ZIP/Postal Code
50935
Country
Germany

12. IPD Sharing Statement

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Iyengar Yoga for Chemotherapy-induced Fatigue in Breast Cancer Patients

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