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CompletedNCT00583739Updated Dec 4, 2008

Yoga to Reduce Cancer Fatigue

A Phase 2 interventional study of Yoga in Breast Neoplasm, sponsored by University of Iowa. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-12-04.

Sponsored by University of Iowa · Phase 2, Interventional, and Supportive care

Phase
Phase 2
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Breast Neoplasm

Keywords

  • Fatigue
  • Yoga
  • Anxiety
  • Quality of Life
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 66 is close to the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

University of Iowa is the lead sponsor of 276 studies on the registry; 35 are open to participants now.

Of its 44 completed or terminated interventional studies of FDA-regulated products, 39 (89%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
66 participants (estimated)

Study arms

  • Active comparator
    1

    Yoga intervention

    Behavioral: Yoga

  • No intervention
    2

    Control. No Yoga for 8 weeks.

Interventions

  • BehavioralYoga

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

06

What researchers measure

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

07

Study locations

1 site
  • The University of Iowa Hospitals & Clinics
    Iowa City, Iowa 52242, United States
08

References and documents

Publications

  • 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. PubMed 16062164 ↗
  • 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. PubMed 16374892 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 4, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00583739
Lead sponsor
University of Iowa
First posted
Dec 31, 2007
Start date
Aug 2007
Primary completion
Oct 2008
Completion
Oct 2008
Last update
Dec 4, 2008

Study contacts

Geraldine Jacobson, MD MPH
principal investigator · department of radiation oncology

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2008. You cannot join it, but the record below documents what was studied.

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