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Completed

NCT Number: NCT00583739

Yoga to Reduce Cancer Fatigue

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The University of Iowa Hospitals & Clinics

Iowa City, Iowa, 52242, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Yoga

Behavioral

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

Primary outcomes

  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 outcomes

  1. Analyze symptoms of depression and anxiety

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

University of Iowa

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Dec 31, 2007
Registry last updated
Dec 4, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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