Yoga to Reduce Cancer Fatigue | NCT00583739

Studies
Yoga to Reduce Cancer Fatigue

NCT00583739

Sponsor

University of Iowa

Status

Completed

Last Update Posted

Dec 4, 2008Estimated

Enrollment

66Estimated

Phase

Phase 2

Conditions

Breast Neoplasm

Interventions

Yoga

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2007

Primary Completion Date

Oct 2008Actual

Completion Date

Oct 2008Actual

First Submitted Date

Dec 20, 2007

First Submission Date that Met QC Criteria

Dec 20, 2007

First Posted Date

Dec 31, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 3, 2008

Last Update Posted Date

Dec 4, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

66Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Yoga intervention	Behavioral: Yoga
2	No Intervention	Control. No Yoga for 8 weeks.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Yoga	Behavioral	Gentle Yoga for breast cancer survivors, 1 time weekly, for 8 weeks.	1

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

Measure	Description	Time Frame
Analyze symptoms of depression and anxiety		8 weeks

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Geraldine Jacobson, MD MPH	department of radiation oncology	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
The University of Iowa Hospitals & Clinics		Iowa City	Iowa	52242	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16062164	Background	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.
16374892	Background	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.

ID	Term
D001943	Breast Neoplasms
D005221	Fatigue
D001008	Anxiety Disorders

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

ID	Term
D026441	Mind-Body Therapies
D000529	Complementary Therapies
D013812	Therapeutics
D026443	Spiritual Therapies