Clinical trial NCT04112966: Lymphedema Prevention in Breast Cancer
Official title: Manual Lymph Drainage in the Prevention of Lymphedema Related to Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lymphedema
Keywords: Lymphedema
Prevention
Lead sponsor: University of Castilla-La Mancha
Sponsor class: OTHER
Collaborators: name: Castilla-La Mancha Health Service
First posted: 2019-10-02
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of breast cancer.
* Undergoing unilateral surgery with axillary lymph-node dissection.

Exclusion Criteria:

* Bilateral breast cancer.
* Systemic disease.
* Locoregional recurrence.
* Any contraindication to physical therapy.

Primary outcomes:
measure: Circumference measurements
timeFrame: 0 months
measure: Circumference measurements
timeFrame: 3 months
measure: Circumference measurements
timeFrame: 6 months
measure: Circumference measurements
timeFrame: 12 months
measure: Circumference measurements
timeFrame: 24 months
measure: Circumference measurements
timeFrame: 36 months
measure: Circumference measurements
timeFrame: 48 months
measure: Circumference measurements
timeFrame: 60 months
Secondary outcomes:
Other outcomes:
Locations:
city: Toledo
country: Spain
facility: Provincial Hospital
Study officials:
affiliation: University of Castilla-La Mancha
name: Helena Romay Barrero, Prof. PhD.
role: PRINCIPAL_INVESTIGATOR
References: