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

July 5, 2016 updated by: Jonsson Comprehensive Cancer Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
prior to beginning of treatment and after treatment ends. Up to an average of 44 weeks.

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
prior to beginning of treatment and after end of treatment. Up to an average of 44 weeks.
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.
prior to beginning of treatment and after conclusion of treatment. Up to an average of 44 weeks.
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.
prior to the beginning of treatment and after end of treatment. Up to an average of 44 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jonsson Comprehensive Cancer Center

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (ACTUAL)

January 1, 2009

Study Completion (ACTUAL)

October 1, 2009

Study Registration Dates

First Submitted

March 25, 2008

First Submitted That Met QC Criteria

March 25, 2008

First Posted (ESTIMATE)

March 28, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

July 7, 2016

Last Update Submitted That Met QC Criteria

July 5, 2016

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06-08-010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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