A Yoga and Wellness Program for Breast Cancer Survivors With Persistent Fatigue

Breast Cancer Clinical Trial

Official title:

Iyengar Yoga for Breast Cancer Survivors With Persistent Fatigue

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00727662
• Other study ID #: U01AT003682
• Status: Completed
• Phase: N/A
• First received: July 31, 2008
• Last updated: April 13, 2015
• Start date: June 2008
• Est. completion date: December 2010

Study information

• Verified date: April 2015
• Source: National Center for Complementary and Integrative Health (NCCIH)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

This randomized controlled trial will compare the effectiveness of an Iyengar Yoga intervention to a Wellness Seminar health education lecture series, for improvements in energy, mood and biological functioning in breast cancer survivors with persistent, post-treatment fatigue. It is anticipated that the Iyengar Yoga intervention will be feasible and acceptable to breast cancer survivors with minimal side effects and that the Yoga intervention will be effective in improving fatigue and physical performance.

Description:

Fatigue is the most common and distressing side effect of cancer treatment and persists beyond successful treatment completion in approximately 30% of breast cancer survivors, causing serious disruption in quality of life. Behavioral interventions incorporating physical activity or relaxation/stress management have demonstrated beneficial effects on cancer-related fatigue, although research in cancer survivors is limited. Mind-body interventions such as yoga are extremely popular among cancer patients and offer a promising alternative to traditional treatments. Research is needed to establish the feasibility and efficacy of these interventions in cancer populations, particularly those who are experiencing problems with fatigue.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 65 Years

Eligibility

Inclusion Criteria:

• Diagnosed with early, resectable breast cancer (Stage I or II)

• Completed treatment with surgery, radiation, and/or chemotherapy between 6 months and 5 years previously

• No other cancer in last 5 years, including breast cancer recurrence

• Postmenopausal women

• Age 40 - 65

• Reporting persistent cancer-related fatigue

Exclusion Criteria:

• Evidence that fatigue is directly related to a medical or psychiatric disorder (e.g., untreated hypothyroidism, diabetes, anemia (defined as hematocrit < 24), chronic fatigue syndrome, current major depression, insomnia, sleep apnea, restless leg syndrome)

• Evidence that fatigue is related to other non-cancer related factors (e.g., shift work, recent change in activity or schedule)

• Physical problems or conditions that could make yoga unsafe (e.g., serious neck injuries, unstable joints; also severe cachexia, dizziness, bone pain, severe nausea, etc)

• Regular use of medications and/or behavioral therapies that would confound evaluation of IY, including regular participation in yoga classes

• Presence of medical conditions that involve the immune system and would confound immune evaluation (e.g., autoimmune disorder, inflammatory disease)

• Use of medications that might confound immune evaluation (e.g., regular use of corticosteroids, narcotics, opiates)

• Unable to commit to intervention schedule

• Body mass index greater than 30 kg/m2

• Regular tobacco (defined as daily or near daily) or alcohol use (defined as > 2 drinks/day)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Fatigue

Intervention

Other:
• Iyengar Yoga
The poses and breathing techniques to be used in this study are based on sequences developed by B.K.S. Iyengar for breast cancer survivors who suffer from fatigue. Women will start with simple versions of the poses and progress to more advanced versions over the course of the intervention.
• Wellness Seminar Series
The Wellness Seminar Series consists of lectures on key topics, followed by group discussion. This series will focus entirely on cancer survivorship, including sessions on quality of life, side effects of cancer treatment, stress, nutrition and psychosocial issues.

Locations

Country	Name	City	State
United States	University of California, Cousins Center for PNI	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Bower JE, Woolery A, Sternlieb B, Garet D. Yoga for cancer patients and survivors. Cancer Control. 2005 Jul;12(3):165-71. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatigue		Measured at baseline, after the 12 week intervention and at 3 months post-intervention	No
Secondary	Secondary outcomes include depressed mood, sleep disturbance, pain, quality of life, and proinflammatory cytokine activity		Measured at baseline, after the 12 week intervention and at 3 months post-intervention	No