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Effects of Yoga in Breast Cancer Patients
This study is ongoing, but not recruiting participants.

First Received on July 27, 2007.   Last Updated on November 11, 2011   History of Changes
Sponsor: M.D. Anderson Cancer Center
Collaborators: National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party): M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00508794
  Purpose

In this study researchers will examine the initial efficacy of implementing a yoga program for patients with breast cancer as an adjuvant to their radiotherapy. Patients with breast cancer who are undergoing radiotherapy will be randomly assigned to either a yoga group (YG), or a stretching (ST) control group, or a waitlist control (WL) group. Participants in YG and ST groups will attend three sessions each week throughout their 6-week radiotherapy schedule. The sessions will be coordinated with the treatment schedule and conducted adjacent to the treatment facility. Measures will be obtained prior to randomization, a brief assessment during the middle of radiation therapy, during the last week of radiation therapy, and 1, 3 and 6 months after the last radiation session. With the inclusion of two control groups in this randomized trial researchers will attempt to validate the benefits of yoga as an adjuvant to radiotherapy in patients with breast cancer wherein researchers will control for specific components of the yoga program and also examine some of the mechanisms that are necessary for the program to be effective.

Our specific aims in the proposed study are to:

  • Conduct an initial evaluation of whether participation in the yoga program improves patients' fatigue and sleep disturbances. Fatigue and sleep will be assessed with self-report measures and the use of actigraphy for a more objective measure of sleep quality.
  • Secondary end points will include examining QOL, mental health and objective physiological outcomes (blood samples for immune measures, saliva samples for cortisol levels, and heart rate variability).
  • Exploratory analyses will examine some plausible mediators of the yoga program including cognitive processing, spirituality, and finding meaning in the cancer experience.

Condition Intervention
Breast Cancer
 Behavioral: Yoga Group
Behavioral: Stretching Control Group
Behavioral: Waitlist Control Group
Other: Questionnaire

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Biobehavioral Effects of Yoga During Breast Cancer Treatment

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer Fatigue
U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Fatigue and sleep assessed with self-report measures and actigraphy. [ Time Frame: Measures will be obtained prior to randomization, a brief assessment during the middle of radiation therapy, during the last week of radiation therapy, and 1, 3 and 6 months after the last radiation session. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To see if yoga will help to improve patients' quality of life (QOL) during treatment for cancer and during recovery from the effects of cancer treatment. [ Time Frame: 4 Years ] [ Designated as safety issue: No ]
  • To learn if a yoga program is effective in helping to decrease emotional distress and improve physiological functioning. [ Time Frame: 4 Years ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: March 2006
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1 Yoga Program Behavioral: Yoga Group
3 sessions of yoga each week for 6 weeks.
Other: Questionnaire
Questionnaire evaluating treatment-related symptoms during the middle of radiotherapy.
Other Name: Survey
Experimental: Group 2 Stretching Program Behavioral: Stretching Control Group
3 sessions of stretching each week for 6 weeks
Other: Questionnaire
Questionnaire evaluating treatment-related symptoms during the middle of radiotherapy.
Other Name: Survey
No Intervention: Group 3 Waitlist Control Group Behavioral: Waitlist Control Group
Option of participating in the yoga or stretching program after the study has ended.
Other: Questionnaire
Questionnaire evaluating treatment-related symptoms during the middle of radiotherapy.
Other Name: Survey

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Women with Stage 0 - III breast cancer, undergoing daily adjuvant radiation for 6 weeks in the Department of Radiation Oncology at the M. D. Anderson.
  2. The participants will need to be 18 years of age or older.
  3. Patients should be able to read, write, and speak English or Spanish.

Exclusion Criteria:

  1. Patients who have a documented diagnosis of a formal thought disorder (e.g., schizophrenia) will be excluded from the study.
  2. Patients with metastatic disease of the bone will be excluded to avoid any bone fractures that may result from yoga movements.
  3. Patients with active/non-canalized deep vein thrombosis will be excluded from the study.
  4. Patients who have not undergone any surgical treatment for their cancer will be excluded to ensure a more homogeneous sample.
  5. Patients with extreme mobility issues (e.g., unable to get in and out of a chair unassisted) will be excluded.
  6. Patients who have practiced yoga or taken yoga classes in the year prior to diagnosis will be excluded.
  7. Patients diagnosed with lymphedema at baseline will be excluded.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00508794

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Investigators
Principal Investigator: Lorenzo Cohen, PhD M.D. Anderson Cancer Center
  More Information

Additional Information:
UT MD Anderson Cancer Center website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00508794     History of Changes
Other Study ID Numbers: 2005-0522
Study First Received: July 27, 2007
Last Updated: November 11, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Breast Cancer
Tibetan Yoga
Stretching Program
Yoga
 Quality of Life
Questionnaire
Survey

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 22, 2012



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