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
NCT ID: NCT00957112
Last Updated: 2013-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
320 participants
INTERVENTIONAL
2007-10-31
2013-02-28
Brief Summary
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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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* 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
SUPPORTIVE_CARE
NONE
Study Groups
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Arm I
Patients undergo a 20-minute acupuncture session once a week for 6 weeks. Patients also receive written information about fatigue and its possible management.
acupuncture therapy
Patients undergo therapist-acupuncture with or without self-acupuncture
Arm II
Patients receive standard care. They also receive written information about fatigue as in arm I.
standard follow-up care
Patients receive standard care
Arm A
Patients receive treatment as in arm I for 4 more weeks.
acupuncture therapy
Patients undergo therapist-acupuncture with or without self-acupuncture
Arm B
Patients receive standard care as in arm II for 4 more weeks.
standard follow-up care
Patients receive standard care
Arm C
Patients learn to self-acupuncture and do so weekly for 4 more weeks.
acupuncture therapy
Patients undergo therapist-acupuncture with or without self-acupuncture
Interventions
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acupuncture therapy
Patients undergo therapist-acupuncture with or without self-acupuncture
standard follow-up care
Patients receive standard care
Eligibility Criteria
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Inclusion Criteria
* 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
FEMALE
No
Sponsors
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University of Manchester
OTHER
Principal Investigators
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Alex Molassiotis, MD
Role: PRINCIPAL_INVESTIGATOR
University of Manchester
Locations
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University of Manchester
Manchester, England, United Kingdom
Countries
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References
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Molassiotis A, Bardy J, Finnegan-John J, Mackereth P, Ryder WD, Filshie J, Ream E, Eaton D, Richardson A. A randomized, controlled trial of acupuncture self-needling as maintenance therapy for cancer-related fatigue after therapist-delivered acupuncture. Ann Oncol. 2013 Jun;24(6):1645-52. doi: 10.1093/annonc/mdt034. Epub 2013 Feb 21.
Molassiotis A, Bardy J, Finnegan-John J, Mackereth P, Ryder DW, Filshie J, Ream E, Richardson A. Acupuncture for cancer-related fatigue in patients with breast cancer: a pragmatic randomized controlled trial. J Clin Oncol. 2012 Dec 20;30(36):4470-6. doi: 10.1200/JCO.2012.41.6222. Epub 2012 Oct 29.
Other Identifiers
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UM-ASA
Identifier Type: -
Identifier Source: secondary_id
EU-20970
Identifier Type: -
Identifier Source: secondary_id
CDR0000649750
Identifier Type: -
Identifier Source: org_study_id