Lymphedema Prevention in Breast Cancer
Manual Lymph Drainage in the Prevention of Lymphedema Related to Breast Cancer
1 other identifier
interventional
150
1 country
1
Brief Summary
OBJECTIVE: To find out the effectiveness of early application of Manual Lymph Drainage in the prevention of upper limb lymphedema after breast surgery and axillary lymphadenectomy in women with breast cancer. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable breast-cancer
Started May 2004
Longer than P75 for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedFirst Submitted
Initial submission to the registry
July 22, 2019
CompletedFirst Posted
Study publicly available on registry
October 2, 2019
CompletedOctober 2, 2019
October 1, 2019
7.4 years
July 22, 2019
October 1, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
Circumference measurements
Circumference measurements of the upper limbs using at 5 cm intervals from the elbow fold preoperatively prior to randomization.
0 months
Circumference measurements
Circumference measurements of the upper limbs using at 5 cm intervals from the elbow fold preoperatively prior to randomization and then post-operatively on 3 months after surgery.
3 months
Circumference measurements
Circumference measurements of the upper limbs using at 5 cm intervals from the elbow fold preoperatively prior to randomization and then post-operatively on 6 months after surgery.
6 months
Circumference measurements
Circumference measurements of the upper limbs using at 5 cm intervals from the elbow fold preoperatively prior to randomization and then post-operatively on 12 months after surgery.
12 months
Circumference measurements
Circumference measurements of the upper limbs using at 5 cm intervals from the elbow fold preoperatively prior to randomization and then post-operatively on 24 months after surgery.
24 months
Circumference measurements
Circumference measurements of the upper limbs using at 5 cm intervals from the elbow fold preoperatively prior to randomization and then post-operatively on 36 months after surgery.
36 months
Circumference measurements
Circumference measurements of the upper limbs using at 5 cm intervals from the elbow fold preoperatively prior to randomization and then post-operatively on 48 months after surgery.
48 months
Circumference measurements
Circumference measurements of the upper limbs using at 5 cm intervals from the elbow fold preoperatively prior to randomization and then post-operatively on 60 months after surgery.
60 months
Study Arms (2)
Early Manual Lymph Drainage
EXPERIMENTAL14 sessions of manual lymphatic drainage technique in the three months following surgery and received health education on the prevention of lymphedema.
Health education for lymphedema prevention
OTHEROnly the health education for lymphedema prevention.
Interventions
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 for lymphedema prevention.
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of breast cancer.
- Undergoing unilateral surgery with axillary lymph-node dissection.
You may not qualify if:
- Bilateral breast cancer.
- Systemic disease.
- Locoregional recurrence.
- Any contraindication to physical therapy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Provincial Hospital
Toledo, 45006, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Helena Romay Barrero, Prof. PhD.
University of Castilla-La Mancha
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 22, 2019
First Posted
October 2, 2019
Study Start
May 1, 2004
Primary Completion
October 1, 2011
Study Completion
October 1, 2016
Last Updated
October 2, 2019
Record last verified: 2019-10