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| ID | Type | Description | Link |
|---|---|---|---|
| UM-ASA | |||
| EU-20970 |
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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.
OBJECTIVES:
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.
After 6 weeks, patients in arm I are again randomized to 1 of 3 arms.
After completion of study therapy, patients are followed up periodically for 18 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | No Intervention | Patients receive standard care. They also receive written information about fatigue as in arm I. |
|
| Arm A | Experimental | Patients receive treatment as in arm I for 4 more weeks. |
|
| Arm B | No Intervention | Patients receive standard care as in arm II for 4 more weeks. |
|
| Arm C | Experimental | Patients learn to self-acupuncture and do so weekly for 4 more weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acupuncture therapy | Procedure | Patients undergo therapist-acupuncture with or without self-acupuncture |
|
| Measure | Description | Time Frame |
|---|---|---|
| General fatigue as measured by the Multidimensional Fatigue Inventory |
| 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 |
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DISEASE CHARACTERISTICS:
Diagnosis of breast cancer
Completed prior chemotherapy for ≥ 1 month and up to 5 years
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:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Alex Molassiotis, MD | University of Manchester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Manchester | Manchester | England | M13 9PL | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23436910 | Derived | 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. | |
| 23109700 |
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| standard follow-up care | Procedure | Patients receive standard care |
|
| Quality of life as measured by the FACT-G and Breast Cancer module |
| 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. |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001943 | Breast Neoplasms |
| D003863 | Depression |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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