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
- Conditions
- Anxiety DisorderBreast CancerDepressionFatigue
- Interventions
- Procedure: acupuncture therapyProcedure: standard follow-up care
- Registration Number
- NCT00957112
- Lead Sponsor
- University of Manchester
- Brief 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.
- Detailed 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 & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 320
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Arm I acupuncture therapy 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 standard follow-up care Patients receive standard care. They also receive written information about fatigue as in arm I. Arm A acupuncture therapy Patients receive treatment as in arm I for 4 more weeks. Arm B standard follow-up care Patients receive standard care as in arm II for 4 more weeks. Arm C acupuncture therapy Patients learn to self-acupuncture and do so weekly for 4 more weeks.
- Primary Outcome Measures
Name Time Method General fatigue as measured by the Multidimensional Fatigue Inventory
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
University of Manchester
🇬🇧Manchester, England, United Kingdom