Clinical trial NCT00583739: Yoga to Reduce Cancer Fatigue
Official title: Effect of a Yoga Intervention on Fatigue, Distress, and Quality of Life in Breast Cancer Patients: A Randomized Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Neoplasm
Keywords: Fatigue
Yoga
Anxiety
Quality of Life
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2007-12-31
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Determine if an 8 week yoga program designed for breast cancer patients improves subjective reports of overall well being and fatigue
timeFrame: 8 weeks
Secondary outcomes:
measure: Analyze symptoms of depression and anxiety
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: The University of Iowa Hospitals & Clinics
state: Iowa
Study officials:
affiliation: department of radiation oncology
name: Geraldine Jacobson, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bower JE, Woolery A, Sternlieb B, Garet D. Yoga for cancer patients and survivors. Cancer Control. 2005 Jul;12(3):165-71. doi: 10.1177/107327480501200304.
citation: Culos-Reed SN, Carlson LE, Daroux LM, Hately-Aldous S. A pilot study of yoga for breast cancer survivors: physical and psychological benefits. Psychooncology. 2006 Oct;15(10):891-7. doi: 10.1002/pon.1021.