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

NCT00727662 | Completed DMC

• 1 other identifier: U01AT003682
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer; Fatigue

Keywords

Breast Cancer; Fatigue; Proinflammatory Cytokines; Physical functioning; Quality of life

Outcome Measures

Primary Outcomes (1)

• Fatigue

  Measured at baseline, after the 12 week intervention and at 3 months post-intervention

Secondary Outcomes (1)

• 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

Study Arms (2)

1

EXPERIMENTAL

Yoga

Other: Iyengar Yoga

2

ACTIVE COMPARATOR

A Wellness Seminar series

Other: Wellness Seminar Series

Interventions

Iyengar Yoga OTHER

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.

Also known as: Yoga

1

Wellness Seminar Series OTHER

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.

Also known as: Health education

2

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• National Center for Complementary and Integrative Health (NCCIH): lead

Study Sites (1)

University of California, Cousins Center for PNI

Los Angeles, California, 90095, United States

Location

Related Publications (1)

• Bower JE, Woolery A, Sternlieb B, Garet D. Yoga for cancer patients and survivors. Cancer Control. 2005 Jul;12(3):165-71. doi: 10.1177/107327480501200304.

  PMID: 16062164 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Fatigue

Interventions

Yoga

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Julienne E Bower, Ph.D.

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 31, 2008
• First Posted: August 4, 2008
• Study Start: June 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: December 1, 2010
• Last Updated: April 14, 2015

Record last verified: 2015-04

Locations

US (1)