Yoga to Reduce Cancer Fatigue

Phase 2

Completed

• Conditions: Breast Neoplasm
• Interventions: Behavioral: Yoga

• Registration Number: NCT00583739
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-12-20
• Study First Submitted QC: 2007-12-20
• Study First Posted: 2007-12-31
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2008-12
• Last Update Submitted: 2008-12-03
• Last Update Posted: 2008-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Yoga	Yoga intervention

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Analyze symptoms of depression and anxiety	8 weeks

Trial Locations

Locations (1)

The University of Iowa Hospitals & Clinics; 🇺🇸 Iowa City, Iowa, United States