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
NA
150 participants
INTERVENTIONAL
2004-05-31
2016-10-31
Brief Summary
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DESIGN: Randomized, controlled and single blinded clinical trial. Five years duration. Patients were randomly assigned to one of these groups: Experimental group: Manual Lymph Drainage + training in means of prevention; Control group: just training in means of prevention. In both groups several physical therapy assessments were undertaken: 1st before surgery; 2nd 3 month after surgery; 4th, 5th, 6th, 7th, 8th and 9th after 6, 12, 24, 36, 48 and 60 months.
SUBJECTS: Women with breast cancer treated with breast surgery including axillary lymphadenectomy in Provincial Hospital of Toledo, provided that there is no contraindication for manual lymph drainage, and after reading, understanding and freely signing an informed consent form.
SAMPLE SIZE: A total of 150 subjects were included in the study (57 subjects in experimental group and 93 in control group), assuming a 20% of drop-outs and at least 25% reduction, with a statistical power of 75%.
DATA ANALYSIS: To find out the effectiveness of intervention the investigators will compare the rate of lymphedema in both groups by means of a logistic regression analysis, in which the main factor is the intervention group. Other factors aimed to control the effect of the intervention will also be included. In order to compare the rate of appearance of lymphedema in both groups, a survival analysis will also be included.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Early Manual Lymph Drainage
14 sessions of manual lymphatic drainage technique in the three months following surgery and received health education on the prevention of lymphedema.
14 sessions of manual lymphatic drainage technique
Early manual lymph drainage including 14 sessions of manual lymphatic drainage technique in the three months following surgery and health education for lymphedema prevention including verbal instructions and written materials.
the health education
The health education for lymphedema prevention.
Health education for lymphedema prevention
Only the health education for lymphedema prevention.
the health education
The health education for lymphedema prevention.
Interventions
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14 sessions of manual lymphatic drainage technique
Early manual lymph drainage including 14 sessions of manual lymphatic drainage technique in the three months following surgery and health education for lymphedema prevention including verbal instructions and written materials.
the health education
The health education for lymphedema prevention.
Eligibility Criteria
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Inclusion Criteria
* Undergoing unilateral surgery with axillary lymph-node dissection.
Exclusion Criteria
* Systemic disease.
* Locoregional recurrence.
* Any contraindication to physical therapy.
18 Years
85 Years
FEMALE
No
Sponsors
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Castilla-La Mancha Health Service
OTHER
University of Castilla-La Mancha
OTHER
Responsible Party
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Principal Investigators
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Helena Romay Barrero, Prof. PhD.
Role: PRINCIPAL_INVESTIGATOR
University of Castilla-La Mancha
Locations
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Provincial Hospital
Toledo, , Spain
Countries
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Other Identifiers
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ECA-DLM-5
Identifier Type: -
Identifier Source: org_study_id
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