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

April 17, 2014 updated by: Janice Kiecolt-Glaser, Ohio State University Comprehensive Cancer Center

Breast Cancer Survivors: Physical Activity, Inflammation, Fatigue, and Distress

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210-1240
        • Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Immediately post-treatment and 3 months post-treatment
Stimulated ln (IL-6)
Time Frame: Immediately post-treatment and 3 months post-treatment
log-transformed Lipopolysaccharide (LPS) stimulated Interleukin-6 (IL-6)
Immediately post-treatment and 3 months post-treatment
Stimulated ln (IL-1b)
Time Frame: Immediately post-treatment and 3 months post-treatment
log-transformed Lipopolysaccharide (LPS) stimulated Interleukin-1 beta (IL-1b)
Immediately post-treatment and 3 months post-treatment
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.
Immediately post-treatment and 3 months post-treatment
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.
Immediately post-treatment and 3 months post-treatment
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.
Immediately post-treatment and 3 months post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Janice Kiecolt-Glaser, PhD, Ohio State University Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

June 13, 2007

First Submitted That Met QC Criteria

June 13, 2007

First Posted (Estimate)

June 14, 2007

Study Record Updates

Last Update Posted (Estimate)

May 5, 2014

Last Update Submitted That Met QC Criteria

April 17, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSU-06137
  • NCI-2012-00564 (Registry Identifier: Clinical Trials Reporting Program (CTRP))
  • R01CA126857 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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