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Completed

NCT Number: NCT00486525

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

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.

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Key information

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210-1240, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Yoga therapy

Procedure

Patients will undergo yoga therapy

Other names: Yoga

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2012
Study completion
2013
First posted
Jun 14, 2007
Registry last updated
May 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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