Lymphedema Prevention in Breast Cancer

Breast Cancer Clinical Trial

Official title:

Manual Lymph Drainage in the Prevention of Lymphedema Related to Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04112966
• Other study ID #: ECA-DLM-5
• Status: Completed
• Phase: N/A
• Start date: May 2004
• Est. completion date: October 2016

Study information

• Verified date: October 2019
• Source: University of Castilla-La Mancha
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: October 2016
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Lymphedema

Intervention

Procedure:
• 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.

Other:
• the health education
The health education for lymphedema prevention.

Locations

Country	Name	City	State
Spain	Provincial Hospital	Toledo

Sponsors (2)

Lead Sponsor	Collaborator
University of Castilla-La Mancha	Castilla-La Mancha Health Service

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Circumference measurements	Circumference measurements of the upper limbs using at 5 cm intervals from the elbow fold preoperatively prior to randomization.	0 months
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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