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Improving Fatigue: A Pilot Study of Acupuncture and Patient Education for Breast Cancer Survivors


Phase 2
18 Years
65 Years
Open (Enrolling)
Both
Fatigue

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Trial Information

Improving Fatigue: A Pilot Study of Acupuncture and Patient Education for Breast Cancer Survivors


Patients will be randomly assigned to one of the two groups. Our hypothesis is that
patients in the acupuncture/education group will experience greater relief of fatigue than
those in the standard care group.


Inclusion Criteria:



1. Patient is between 18 and 65 years of age

2. Patient has a rounded Brief Fatigue Inventory score of 4 or greater

3. Patient is in a stable clinical condition

Exclusion Criteria:

1. Severe anemia (hemoglobin level less than 9 g/dL, hematocrit level less than 30,
decline in hemoglobin of 2 g/dL in the previous month, or active treatment for
anemia)

2. Karnofsky Performance Status below 70

3. Acupuncture treatment in the previous 6 months

4. Fatigue before cancer diagnosis

5. Patient is mentally incapacitated or unfit to provide informed consent or participate
in an interview

6. Patient has the potential for serious bleeding due to inherited diseases such as
hemophilia

7. Patient is taking medications that are either fatigue-inducing or have sedating
properties

8. Patient is unavailable by telephone

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Fatigue as measured by the Brief Fatigue Inventory

Outcome Time Frame:

prior to beginning of treatment and after treatment ends

Safety Issue:

No

Principal Investigator

Ka-Kit Hui, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

UCLA Center for East-West Medicine, 1033 Gayley Ave, Suite 111, Los Angeles, CA 90024

Authority:

United States: Institutional Review Board

Study ID:

06-08-010

NCT ID:

NCT00646633

Start Date:

March 2008

Completion Date:

March 2009

Related Keywords:

  • Fatigue
  • Cancer
  • Acupuncture
  • Breast Neoplasms
  • Fatigue

Name

Location

UCLA Center for East-West Medicine Santa Monica, California  90404