Acupuncture or Self-Acupuncture in Managing Cancer-Related Fatigue in Women Who Have Received Chemotherapy for Stage I, Stage II, or Stage IIIA Breast Cancer

Breast Cancer Clinical Trial

Official title:

The Efficacy of Acupuncture and Self-acupuncture in Managing Cancer-related Fatigue in Breast Cancer Patients: a Pragmatic Randomised Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00957112
• Other study ID #: CDR0000649750
• Secondary ID: UM-ASAEU-20970
• Status: Completed
• Phase: Phase 3
• First received: August 11, 2009
• Last updated: August 23, 2013
• Start date: October 2007
• Est. completion date: February 2013

Study information

• Verified date: August 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Acupuncture may help relieve fatigue caused by breast cancer. It is not yet known whether acupuncture is more effective than self-acupuncture in managing fatigue in women with breast cancer.

PURPOSE: This randomized phase III trial is studying acupuncture to see how well it works compared with self-acupuncture in managing cancer-related fatigue in women who have received chemotherapy for stage I, stage II, or stage IIIA breast cancer.

Description:

OBJECTIVES:

• Assess the efficacy of a course of acupuncture in the management of cancer-related fatigue in a homogeneous sample of women with stage I, II, or IIIA breast cancer who have completed adjuvant chemotherapy.

• Assess the efficacy of self-acupuncture in comparison to therapist-administered acupuncture in sustaining, in the longer term, any effects observed with a 6-week course of acupuncture in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to study center and fatigue score (low vs moderate vs severe). Patients are randomized at 3:1 ratio (arm I: arm II) to 1 of 2 treatment arms.

• Arm I (experimental): Patients undergo a 20-minute acupuncture session once a week for 6 weeks. Patients also receive written information about fatigue and its possible management.

• Arm II (control): Patients undergo standard care. They also receive written information about fatigue as in arm I.

After 6 weeks, patients in arm I are again randomized to 1 of 3 arms.

• Arm A: Patients receive treatment as in arm I for 4 more weeks.

• Arm B: Patients receive treatment as in arm II for 4 more weeks.

• Arm C: Patients learn to self-acupuncture and do so weekly for 4 more weeks. All patients complete questionnaires on fatigue, hospital anxiety and depression, quality of life, and use of complementary therapies at baseline and periodically during study. Patient's sociodemographic and treatment characteristic records are also reviewed.

After completion of study therapy, patients are followed up periodically for 18 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: February 2013
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

DISEASE CHARACTERISTICS:

• Diagnosis of breast cancer

• Stage I, II, or IIIA disease

• Completed prior chemotherapy for = 1 month and up to 5 years

• No needling on the ipsilateral arm of patients who have undergone axillary dissection

• No needling on the lymphedematous limbs

• Score of = 5 on a 0-10 single-item screening fatigue scale, where 0 is no fatigue at all and 10 is extremely fatigued

• Hormone receptor status not specified

PATIENT CHARACTERISTICS:

• Life expectancy = 6 months

• Menopausal status not specified

• Platelet count = 50,000/mm^3

• Hemoglobin = 10 g/dL

• Hematocrit = 30%

• Not pregnant

• No needle phobia

• No co-morbidity with any of the following:

• Bleeding disorder

• Thyroid dysfunction

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No planned concurrent chemoradiotherapy

• No concurrent steroids

• No concurrent epoetin alfa or transfusion for anemia

• No other concurrent complementary therapies

Study Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Anxiety Disorder
• Anxiety Disorders
• Breast Cancer
• Breast Neoplasms
• Depression
• Fatigue

Intervention

Procedure:
• acupuncture therapy
Patients undergo therapist-acupuncture with or without self-acupuncture
• standard follow-up care
Patients receive standard care

Locations

Country	Name	City	State
United Kingdom	University of Manchester	Manchester	England

Sponsors (1)

Lead Sponsor	Collaborator
University of Manchester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	General fatigue as measured by the Multidimensional Fatigue Inventory			No
Secondary	Mental fatigue as measured by the Multidimensional Fatigue Inventory			No
Secondary	Anxiety as measured by the Hospital Anxiety and Depression Scale			No
Secondary	Depression as measured by the Hospital Anxiety and Depression Scale			No
Secondary	Quality of life as measured by the FACT-G and Breast Cancer module			No