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Iyengar Yoga for Breast Cancer Survivors With Persistent Fatigue


N/A
40 Years
65 Years
Open (Enrolling)
Female
Breast Cancer, Fatigue

Thank you

Trial Information

Iyengar Yoga for Breast Cancer Survivors With Persistent Fatigue


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.


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)

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Fatigue

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

Julienne E Bower, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, Los Angeles

Authority:

United States: Federal Government

Study ID:

U01 AT003682

NCT ID:

NCT00727662

Start Date:

June 2008

Completion Date:

December 2010

Related Keywords:

  • Breast Cancer
  • Fatigue
  • Breast Cancer
  • Fatigue
  • Proinflammatory Cytokines
  • Physical functioning
  • Quality of life
  • Breast Neoplasms
  • Fatigue

Name

Location

University of California, Cousins Center for PNI Los Angeles, California  90095