Status:
COMPLETED
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
Lead Sponsor:
University of Manchester
Conditions:
Anxiety Disorder
Breast Cancer
Eligibility:
FEMALE
Phase:
PHASE3
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...
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 ad...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2013
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT00957112
Start Date
October 1 2007
End Date
February 1 2013
Last Update
August 26 2013
Active Locations (1)
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1
University of Manchester
Manchester, England, United Kingdom, M13 9PL