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

This study has been completed.
Sponsor:
Collaborator:
Susan G. Komen Breast Cancer Foundation
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00646633
First received: March 25, 2008
Last updated: July 5, 2016
Last verified: March 2008

March 25, 2008
July 5, 2016
March 2008
January 2009   (final data collection date for primary outcome measure)
Fatigue as measured by the Brief Fatigue Inventory [ Time Frame: prior to beginning of treatment and after treatment ends. Up to an average of 44 weeks. ] [ Designated as safety issue: No ]
Fatigue as measured by the Brief Fatigue Inventory [ Time Frame: prior to beginning of treatment and after treatment ends ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00646633 on ClinicalTrials.gov Archive Site
  • Health-Related Quality of Life (HRQoL) as measured by the SF36 [ Time Frame: prior to beginning of treatment and after end of treatment. Up to an average of 44 weeks. ] [ Designated as safety issue: No ]
  • Pain as measured by an analog scale [ Time Frame: prior to beginning of treatment and after conclusion of treatment. Up to an average of 44 weeks. ] [ Designated as safety issue: No ]
  • Cognitive complaints as measured by the FACT-COG [ Time Frame: prior to the beginning of treatment and after end of treatment. Up to an average of 44 weeks. ] [ Designated as safety issue: No ]
  • Health-Related Quality of Life (HRQoL) as measured by the SF36 [ Time Frame: prior to beginning of treatment and after end of treatment ] [ Designated as safety issue: No ]
  • Pain as measured by an analog scale [ Time Frame: prior to beginning of treatment and after conclusion of treatment ] [ Designated as safety issue: No ]
  • Cognitive complaints as measured by the FACT-COG [ Time Frame: prior to the beginning of treatment and after end of treatment ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Improving Fatigue: A Pilot Study of Acupuncture and Patient Education for Breast Cancer Survivors
Improving Fatigue: A Pilot Study of Acupuncture and Patient Education for Breast Cancer Survivors
Based on the investigators clinical experience in patients with chronic disease (Hui, Hui, and Johnston, 2006; Hays et al 2005), a review of the literature (Johnston, Xiao and Hui 2007), and inspired by Vickers and colleagues (PMID: 15117996), the investigators carry out a pilot study that investigates if acupuncture combined with patient education will relieve fatigue in patients who have completed primary treatment for breast cancer.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Fatigue
Procedure: Acupuncture and patient education
Acupuncture involves the insertion of extremely thin needles, much thinner than those used for drawing blood, into very specific acupuncture points. Patients will receive a total of 8 acupuncture treatments, each lasting 50 minutes. Patient education will be delivered to individuals over the course of approximately 50 minutes for each of the four sessions; topics will include acupressure, nutrition, exercise, stress management, and lifestyle advice.
Other Name: Traditional Chinese Medicine, Integrative East-West Medicine
  • Active Comparator: Acupuncture & educ
    Patients will receive a total of 8 acupuncture treatments. In each of the first four sessions, they will also receive patient education.
    Intervention: Procedure: Acupuncture and patient education
  • No Intervention: 2. Standard care
    Patients in the control arm will continue to receive standard care from their physician.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
October 2009
January 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00646633
06-08-010
Yes
Not Provided
Not Provided
Jonsson Comprehensive Cancer Center
Jonsson Comprehensive Cancer Center
Susan G. Komen Breast Cancer Foundation
Principal Investigator: Ka-Kit Hui, M.D. UCLA Center for East-West Medicine, 1033 Gayley Ave, Suite 111, Los Angeles, CA 90024
Jonsson Comprehensive Cancer Center
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP