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Yoga to Reduce Cancer Fatigue

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00583739
Recruitment Status : Completed
First Posted : December 31, 2007
Last Update Posted : December 4, 2008
Information provided by:
University of Iowa

Brief Summary:
A randomized trial from the British National Health Service found that supervised exercise benefits women with early stage breast cancer with improved functional and psychological benefit after a 12-week intervention and 6 months later. Considering the needs of breast cancer patients and survivors and the reported benefits of exercise and yoga intervention, the investigators propose a pilot study of an 8-week yoga intervention in breast cancer patients. This study would specifically address measures of fatigue and psychosocial distress in the population of breast cancer patients during treatment and within the year following treatment. Currently there is very limited literature on yoga intervention in this population.

Condition or disease Intervention/treatment Phase
Breast Neoplasm Behavioral: Yoga Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effect of a Yoga Intervention on Fatigue, Distress, and Quality of Life in Breast Cancer Patients: A Randomized Pilot Study
Study Start Date : August 2007
Primary Completion Date : October 2008
Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
Yoga intervention
Behavioral: Yoga
Gentle Yoga for breast cancer survivors, 1 time weekly, for 8 weeks.
No Intervention: 2
Control. No Yoga for 8 weeks.

Primary Outcome Measures :
  1. Determine if an 8 week yoga program designed for breast cancer patients improves subjective reports of overall well being and fatigue [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Analyze symptoms of depression and anxiety [ Time Frame: 8 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Potential subjects must have had histologically or cytologically confirmed breast cancer. This includes, but is not limited to: breast cancer-in situ; ductal carcinoma in situ; lobular carcinoma in situ; cystosarcoma phyllodes; inflammatory breast carcinoma; invasive breast carcinoma; and breast cancer not otherwise specified; cancer must be stage 0 through stage III.
  • Treatment completion within the past calendar year.
  • Age ≥ 18 years. While breast cancer can occur in the pediatric population, the pediatric population is best served by trials specifically designed for their age group.
  • Life expectancy of greater than 1 year.
  • Karnofsky ≥ 60%; see Appendix A.
  • Women of childbearing potential are eligible for this study.
  • Pregnant women are eligible for this study pending a doctor's note.
  • The ability to understand and complete the study questionnaires.
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Patients who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
  • Patients with known metastasis.
  • Patients who are actively participating in a yoga class.
  • Known uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would compromise subject health during yoga.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00583739

United States, Iowa
The University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
Principal Investigator: Geraldine Jacobson, MD MPH department of radiation oncology

Responsible Party: Geraldine Jacobson, MD, MPH, Department of Radiation Oncology
ClinicalTrials.gov Identifier: NCT00583739     History of Changes
Other Study ID Numbers: 200707733
First Posted: December 31, 2007    Key Record Dates
Last Update Posted: December 4, 2008
Last Verified: December 2008

Keywords provided by University of Iowa:
Quality of Life

Additional relevant MeSH terms:
Breast Neoplasms
Signs and Symptoms
Neoplasms by Site
Breast Diseases
Skin Diseases