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Hatha Yoga in Improving Physical Activity, Inflammation, Fatigue, and Distress in Postmenopausal Breast Cancer Survivors

This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), November 2007

Sponsors and Collaborators: Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00526526
  Purpose

RATIONALE: Yoga may improve inflammation, fatigue, and depression in postmenopausal breast cancer survivors.

PURPOSE: This randomized clinical trial is studying how well Hatha yoga works in improving physical activity, inflammation, fatigue, and distress in postmenopausal breast cancer survivors.


Condition Intervention
Breast Cancer
Depression
Fatigue
Pain
Procedure: chromatography
Procedure: fatigue assessment and management
Procedure: flow cytometry
Procedure: immunoenzyme technique
Procedure: management of therapy complications
Procedure: observation
Procedure: psychosocial assessment and care
Procedure: quality-of-life assessment
Procedure: yoga therapy

Genetics Home Reference related topics:   breast cancer   

MedlinePlus related topics:   Breast Cancer    Cancer    Depression   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Supportive Care, Randomized, Double-Blind, Active Control
Official Title:   Breast Cancer Survivors: Physical Activity, Inflammation, Fatigue, and Distress

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Proinflammatory cytokines
  • Fatigue
  • Depressive symptoms

Secondary Outcome Measures:
  • Psychological (quality of life, perceived stress, and stress responsiveness)
  • Behavioral (health behaviors)
  • Physical functioning (physical symptoms, pain, flexibility, and functional status)
  • Physiological stress responses (NF-κB and proinflammatory cytokine responses to a laboratory stressor assessed at baseline)

Estimated Enrollment:   250
Study Start Date:   August 2007
Estimated Primary Completion Date:   August 2013 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

  • To determine if the yoga intervention will decrease inflammation, fatigue, and depressive symptoms relative to the waiting-list controls in women who are stage I-IIIa breast cancer survivors.

Secondary

  • To determine the extent to which the yoga intervention modulates psychological, behavioral, and physical functioning in these patients.
  • To evaluate the relationship between depressive symptoms and the magnitude of the physiological responses elicited by a laboratory stressor, as well as the relationship of both to fatigue in these patients.
  • To assess the extent to which the yoga intervention will decrease physiological stress responses in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to stage of cancer (stage I vs stage II and stage IIIA) and prior radiation therapy (yes vs no). Patients are randomized to 1 of 2 intervention arms.

  • Arm I (waiting-list control): Patients are encouraged to perform usual activities, but asked to refrain from any yoga practice or other related activities. After a six-month observation period, patients undergo yoga intervention as described in arm II .
  • Arm II (yoga intervention): Patients participate in a Hatha yoga intervention session comprising body postures and breath control techniques for 1.5 hours twice a week for 12 weeks. Patients are encouraged to practice Hatha yoga at home with the support of appropriate monthly DVD/video segments. Patients complete daily diaries on home Hatha yoga practices and submit them at each session.

In both arms, patients are physically assessed, interviewed, and then complete heath and health-related behavior questionnaires regarding psychological (quality of life, perceived stress, and stress responsiveness), behavioral (health behaviors), physical functioning (physical symptoms, pain, flexibility, and functional status), and physiological stress responses (NF-κB and proinflammatory cytokine responses to a laboratory stressor) at baseline, 3 months, and 6 months.

Patients undergo fasting blood sample collection at baseline, 3 months, and 6 months to analyze fatty acid composition of plasma by gas chromatography, changes in immune function, proinflammatory cytokine, and key inflammation markers of fatigue and stress by ELISA, flow cytometry, and indirect immunofluorescence (IF) test. Additionally, patient response to laboratory stressors are assessed at baseline using the Trier Social Stress Test (TSST). Saliva samples are collected periodically and before and after the TSST for cortisol level measurement.

  Eligibility
Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS:

  • Stage I-IIIA breast cancer survivor
  • Completed cancer treatment within the past 24 months (except for tamoxifen/aromatase inhibitors)

    • Must have received chemotherapy or radiotherapy OR surgery only, as part of treatment
    • At least 2 months since prior surgery, adjuvant therapy, or radiotherapy, whichever occurred last
  • Women who are not currently practicing yoga and have not participated in any of the following activities:

    • Meditation, tai chi, or related activities
    • Yoga or tai chi within the past 6 months
    • Had classes for or practiced yoga for more than 3 months
  • Women who typically engage in a total of 5 or more hours of vigorous physical activity per week are not eligible
  • No diagnosed lymphedema
  • No inflammatory breast cancer
  • Hormone receptor status not specified

PATIENT CHARACTERISTICS:

Inclusion criteria:

  • Hemoglobin ≥ 10 g/dL (patients with a hemoglobin of < 10 g/dL may be retested in 6 weeks after treatment of anemia and allowed to participate in study if blood counts recovered)
  • Physically able to fully participate in yoga intervention

Exclusion criteria:

  • Inability to comfortably get up and down from the floor 2-3 times in a session
  • Breathing problems requiring use of oxygen
  • Problems walking without a cane or walker assistance
  • Prior knee or hip replacement with limited movement in the joint
  • Inability to comfortably lie on the stomach
  • Body mass index (BMI) ≥ 40
  • Alcohol, or drug abuse
  • Diagnosis of any of the following conditions:

    • Diabetes
    • Chronic obstructive pulmonary disease
    • Uncontrolled hypertension
    • Evidence of liver or kidney failure
    • Symptomatic ischemic heart disease
    • Significant visual or auditory problems
    • Mental disorder or cognitive impairment
    • Notable serious cardiovascular history (e.g., prior life-threatening abnormal heart rhythms)
    • Other medical conditions involving the immune system such as autoimmune and/or inflammatory diseases including rheumatoid arthritis and ulcerative colitis
  • Prior history of breast or any other cancer, except basal or squamous cell cancer

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No neoadjuvant therapy
  • No regular use of medications with major immunological consequences (e.g., steroids)
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00526526

Locations
United States, Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center     Recruiting
      Columbus, Ohio, United States, 43210-1240
      Contact: Clinical Trials Office - OSU Comprehensive Cancer Center     614-293-4976     osu@emergingmed.com    

Sponsors and Collaborators
Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
National Cancer Institute (NCI)

Investigators
Study Chair:     Janice Kiecolt-Glaser, PhD     Arthur G. James Cancer Hospital & Richard J. Solove Research Institute    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000562452, OSU-2007C0004, OSU-06137
First Received:   September 5, 2007
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00526526
Health Authority:   Unspecified

Keywords provided by National Cancer Institute (NCI):
fatigue  
depression  
pain  
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer

Study placed in the following topic categories:
Signs and Symptoms
Depression
Fatigue
Skin Diseases
Mental Disorders
Mood Disorders
Breast Neoplasms
Pain
Depressive Disorder
Breast Diseases
Behavioral Symptoms
Inflammation

Additional relevant MeSH terms:
Neoplasms
Pathologic Processes
Neoplasms by Site

ClinicalTrials.gov processed this record on October 16, 2008




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