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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00486525
• Other study ID #: OSU-06137
• Secondary ID: NCI-2012-00564R0
• Status: Completed
• Phase: N/A
• First received: June 13, 2007
• Last updated: April 17, 2014
• Start date: August 2007
• Est. completion date: March 2013

Study information

• Verified date: April 2014
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00526526

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Depression
• Fatigue
• Pain

Intervention

Procedure:
• Yoga Therapy
Patients will undergo yoga therapy

Locations

Country	Name	City	State
United States	Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Kiecolt-Glaser JK, Bennett JM, Andridge R, Peng J, Shapiro CL, Malarkey WB, Emery CF, Layman R, Mrozek EE, Glaser R. Yoga's impact on inflammation, mood, and fatigue in breast cancer survivors: a randomized controlled trial. J Clin Oncol. 2014 Apr 1;32(10 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stimulated ln (TNF-a)	log-transformed Lipopolysaccharide (LPS) stimulated Tumor Necrosis Factor-alpha (TNF-alpha)	Immediately post-treatment and 3 months post-treatment	No
Primary	Stimulated ln (IL-6)	log-transformed Lipopolysaccharide (LPS) stimulated Interleukin-6 (IL-6)	Immediately post-treatment and 3 months post-treatment	No
Primary	Stimulated ln (IL-1b)	log-transformed Lipopolysaccharide (LPS) stimulated Interleukin-1 beta (IL-1b)	Immediately post-treatment and 3 months post-treatment	No
Primary	MFSI-SF Fatigue	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	No
Primary	Vitality, SF-36	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	No
Primary	CES-D	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	No

External Links

•   The Jamesline