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
  Purpose
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.

Condition Intervention
Fatigue
Procedure: Acupuncture and patient education

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Improving Fatigue: A Pilot Study of Acupuncture and Patient Education for Breast Cancer Survivors

Resource links provided by NLM:


Further study details as provided by Jonsson Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 12
Study Start Date: March 2008
Study Completion Date: October 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
No Intervention: 2. Standard care
Patients in the control arm will continue to receive standard care from their physician.

Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00646633

Locations
United States, California
UCLA Center for East-West Medicine
Santa Monica, California, United States, 90404
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Susan G. Komen Breast Cancer Foundation
Investigators
Principal Investigator: Ka-Kit Hui, M.D. UCLA Center for East-West Medicine, 1033 Gayley Ave, Suite 111, Los Angeles, CA 90024
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00646633     History of Changes
Other Study ID Numbers: 06-08-010 
Study First Received: March 25, 2008
Last Updated: July 5, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Jonsson Comprehensive Cancer Center:
Cancer
Acupuncture

Additional relevant MeSH terms:
Fatigue
Signs and Symptoms

ClinicalTrials.gov processed this record on August 30, 2016