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Effect of a Yoga Intervention on Fatigue, Distress, and Quality of Life in Breast Cancer Patients: A Randomized Pilot Study

Phase 2
18 Years
Not Enrolling
Breast Neoplasm

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Trial Information

Effect of a Yoga Intervention on Fatigue, Distress, and Quality of Life in Breast Cancer Patients: A Randomized Pilot Study

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

- 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

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Determine if an 8 week yoga program designed for breast cancer patients improves subjective reports of overall well being and fatigue

Outcome Time Frame:

8 weeks

Safety Issue:


Principal Investigator

Geraldine Jacobson, MD MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

department of radiation oncology


United States: Institutional Review Board

Study ID:




Start Date:

August 2007

Completion Date:

October 2008

Related Keywords:

  • Breast Neoplasm
  • Fatigue
  • Yoga
  • Anxiety
  • Quality of Life
  • Breast Neoplasms
  • Neoplasms
  • Fatigue



The University of Iowa Hospitals & Clinics Iowa City, Iowa  52242