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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Anxiety Disorder, Breast Cancer, Depression, Fatigue

Intervention / Treatment
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* Procedure: acupuncture therapy
* Procedure: standard follow-up care


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>Patients undergo a 20-minute acupuncture session once a week for 6 weeks. Patients also receive written information about fatigue and its possible management. | Procedure: acupuncture therapy<br>* Patients undergo therapist-acupuncture with or without self-acupuncture<br>|
| No Intervention: Arm II<br>Patients receive standard care. They also receive written information about fatigue as in arm I. | Procedure: standard follow-up care<br>* Patients receive standard care<br>|
| Experimental: Arm A<br>Patients receive treatment as in arm I for 4 more weeks. | Procedure: acupuncture therapy<br>* Patients undergo therapist-acupuncture with or without self-acupuncture<br>|
| No Intervention: Arm B<br>Patients receive standard care as in arm II for 4 more weeks. | Procedure: standard follow-up care<br>* Patients receive standard care<br>|
| Experimental: Arm C<br>Patients learn to self-acupuncture and do so weekly for 4 more weeks. | Procedure: acupuncture therapy<br>* Patients undergo therapist-acupuncture with or without self-acupuncture<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General fatigue as measured by the Multidimensional Fatigue Inventory |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mental fatigue as measured by the Multidimensional Fatigue Inventory |  |  | 
| Anxiety as measured by the Hospital Anxiety and Depression Scale |  |  | 
| Depression as measured by the Hospital Anxiety and Depression Scale |  |  | 
| Quality of life as measured by the FACT-G and Breast Cancer module |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anxiety disorder, depression, fatigue, stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer