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

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ClinicalTrials.gov Identifier: NCT00486525
Recruitment Status : Completed
First Posted : June 14, 2007
Results First Posted : April 10, 2014
Last Update Posted : May 5, 2014
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Janice Kiecolt-Glaser, Ohio State University Comprehensive Cancer Center

Brief Summary:

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

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


Condition or disease Intervention/treatment Phase
Breast Cancer Depression Fatigue Pain Procedure: Yoga Therapy Not Applicable

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 0-IIIa breast cancer survivors.

OUTLINE: Patients are stratified according to stage of cancer (stage 0 vs 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. Patients complete daily diaries on home Hatha yoga practices and submit them at each session.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Breast Cancer Survivors: Physical Activity, Inflammation, Fatigue, and Distress
Study Start Date : August 2007
Actual Primary Completion Date : November 2012
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Arm I: Yoga Therapy
Patients participate in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients are also encouraged to practice yoga at home using the appropriate DVD/video segments for the month.
Procedure: Yoga Therapy
Patients will undergo yoga therapy
Other Name: Yoga
No Intervention: Arm II: Wait-List
Wait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes.



Primary Outcome Measures :
  1. Stimulated ln (TNF-a) [ Time Frame: Immediately post-treatment and 3 months post-treatment ]
    log-transformed Lipopolysaccharide (LPS) stimulated Tumor Necrosis Factor-alpha (TNF-alpha)

  2. Stimulated ln (IL-6) [ Time Frame: Immediately post-treatment and 3 months post-treatment ]
    log-transformed Lipopolysaccharide (LPS) stimulated Interleukin-6 (IL-6)

  3. Stimulated ln (IL-1b) [ Time Frame: Immediately post-treatment and 3 months post-treatment ]
    log-transformed Lipopolysaccharide (LPS) stimulated Interleukin-1 beta (IL-1b)

  4. MFSI-SF Fatigue [ Time Frame: Immediately post-treatment and 3 months post-treatment ]

    The 30-item Multidimensional Fatigue Symptom Inventory-Short form (MFSI-SF) assesses behavioral, cognitive, physical, and affective expressions of fatigue.

    Items are rated on a 5-point scale indicating how true each statement was for the respondent during the last week (0=not at all; 4=extremely). The total score represents the sum of the subscales measuring general, physical, emotional, and mental fatigue, minus the vigor scale, providing a possible range of scores from -24 to 96, with higher scores indicating greater fatigue.


  5. Vitality, SF-36 [ Time Frame: Immediately post-treatment and 3 months post-treatment ]

    The SF-36's (RAND Health Survey) energy/fatigue (vitality) scale focuses on the frequency of feelings of fatigue over the last month.

    Standardized scores on the RAND SF-36 vigor/vitality scale range from 0-100, with higher scores indicating less fatigue.


  6. CES-D [ Time Frame: Immediately post-treatment and 3 months post-treatment ]

    The Center for Epidemiological Studies Depression Scale (CES-D) is a self-report scale designed to measure current symptoms of depression rated on a four-point likert scale.

    Scores range from 0-60, with higher scores indicating a higher frequency of depressive symptoms.




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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Stage 0-IIIA breast cancer survivor
  • Completed cancer treatment within the past 36 months (except for tamoxifen/aromatase inhibitors)

    • 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 inflammatory breast cancer

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
  • 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
  • History of breast or any other cancer, except basal or squamous cell skin cancer

PRIOR CONCURRENT THERAPY:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00486525


Locations
United States, Ohio
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210-1240
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
Study Chair: Janice Kiecolt-Glaser, PhD Ohio State University Comprehensive Cancer Center

Additional Information:
Publications of Results:
Responsible Party: Janice Kiecolt-Glaser, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00486525     History of Changes
Obsolete Identifiers: NCT00526526
Other Study ID Numbers: OSU-06137
NCI-2012-00564 ( Registry Identifier: Clinical Trials Reporting Program (CTRP) )
R01CA126857 ( U.S. NIH Grant/Contract )
First Posted: June 14, 2007    Key Record Dates
Results First Posted: April 10, 2014
Last Update Posted: May 5, 2014
Last Verified: April 2014

Keywords provided by Janice Kiecolt-Glaser, Ohio State University Comprehensive Cancer Center:
fatigue
depression
pain
cancer survivor
stage IA breast cancer
stage IB breast cancer
stage II breast cancer
stage IIIA breast cancer
breast cancer in situ

Additional relevant MeSH terms:
Breast Neoplasms
Depression
Inflammation
Fatigue
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Behavioral Symptoms
Pathologic Processes
Signs and Symptoms