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

Fatigue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00646633
• Other study ID #: 06-08-010
• Status: Completed
• Phase: N/A
• First received: March 25, 2008
• Last updated: July 5, 2016
• Start date: March 2008
• Est. completion date: October 2009

Study information

• Verified date: March 2008
• Source: Jonsson Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: October 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Fatigue

Intervention

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.

Locations

Country	Name	City	State
United States	UCLA Center for East-West Medicine	Santa Monica	California

Sponsors (2)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center	Susan G. Komen Breast Cancer Foundation

Country where clinical trial is conducted

United States, 

References & Publications (4)

Hays RD, Brodsky M, Johnston MF, Spritzer KL, Hui KK. Evaluating the statistical significance of health-related quality-of-life change in individual patients. Eval Health Prof. 2005 Jun;28(2):160-71. — View Citation

Hui KK, Hui EK, Johnston MF. The potential of a person-centered approach in caring for patients with cancer: a perspective from the UCLA center for East-West medicine. Integr Cancer Ther. 2006 Mar;5(1):56-62. Review. — View Citation

Johnston MF, Xiao B, Hui KK. Acupuncture and fatigue: current basis for shared communication between breast cancer survivors and providers. J Cancer Surviv. 2007 Dec;1(4):306-12. doi: 10.1007/s11764-007-0035-9. Epub 2007 Oct 31. — View Citation

Vickers AJ, Straus DJ, Fearon B, Cassileth BR. Acupuncture for postchemotherapy fatigue: a phase II study. J Clin Oncol. 2004 May 1;22(9):1731-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatigue as measured by the Brief Fatigue Inventory		prior to beginning of treatment and after treatment ends. Up to an average of 44 weeks.	No
Secondary	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.	No
Secondary	Pain as measured by an analog scale		prior to beginning of treatment and after conclusion of treatment. Up to an average of 44 weeks.	No
Secondary	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.	No