Yoga to Reduce Cancer Fatigue

Breast Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00583739
• Other study ID #: 200707733
• Status: Completed
• Phase: Phase 2
• First received: December 20, 2007
• Last updated: December 3, 2008
• Start date: August 2007
• Est. completion date: October 2008

Study information

• Verified date: December 2008
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Breast Neoplasm
• Breast Neoplasms

Intervention

Behavioral:
• Yoga
Gentle Yoga for breast cancer survivors, 1 time weekly, for 8 weeks.

Locations

Country	Name	City	State
United States	The University of Iowa Hospitals & Clinics	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
University of Iowa

Country where clinical trial is conducted

United States, 

References & Publications (2)

Bower JE, Woolery A, Sternlieb B, Garet D. Yoga for cancer patients and survivors. Cancer Control. 2005 Jul;12(3):165-71. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine if an 8 week yoga program designed for breast cancer patients improves subjective reports of overall well being and fatigue		8 weeks	No
Secondary	Analyze symptoms of depression and anxiety		8 weeks	No