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

Not Applicable

Completed

• Conditions: Fatigue
• Interventions: Procedure: Acupuncture and patient education

• Registration Number: NCT00646633
• Lead Sponsor: Jonsson Comprehensive Cancer Center

Brief Summary

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.

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 Timeline

• Status Verified: 2008-03
• Study Start: 2008-03
• Study First Submitted: 2008-03-25
• Study First Submitted QC: 2008-03-25
• Study First Posted: 2008-03-28
• Primary Completion: 2009-01
• Study Completion: 2009-10
• Last Update Submitted: 2016-07-05
• Last Update Posted: 2016-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acupuncture & educ	Acupuncture and patient education	Patients will receive a total of 8 acupuncture treatments. In each of the first four sessions, they will also receive patient education.

Primary Outcome Measures

Name	Time	Method
Fatigue as measured by the Brief Fatigue Inventory	prior to beginning of treatment and after treatment ends. Up to an average of 44 weeks.

Secondary Outcome Measures

Name	Time	Method
Health-Related Quality of Life (HRQoL) as measured by the SF36	prior to beginning of treatment and after end of treatment. Up to an average of 44 weeks.
Pain as measured by an analog scale	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	prior to the beginning of treatment and after end of treatment. Up to an average of 44 weeks.

Trial Locations

Locations (1)

UCLA Center for East-West Medicine; 🇺🇸 Santa Monica, California, United States