Lymphedema Prevention in Breast Cancer

Overview

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.

Full Title of Study: “Manual Lymph Drainage in the Prevention of Lymphedema Related to Breast Cancer”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: October 2011

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: 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.
  • Other: Health education for lymphedema prevention
    • Only the health education for lymphedema prevention.

Clinical Trial Outcome Measures

Primary Measures

  • Circumference measurements
    • Time Frame: 0 months
    • Circumference measurements of the upper limbs using at 5 cm intervals from the elbow fold preoperatively prior to randomization.
  • Circumference measurements
    • Time Frame: 3 months
    • 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.
  • Circumference measurements
    • Time Frame: 6 months
    • 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.
  • Circumference measurements
    • Time Frame: 12 months
    • 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.
  • Circumference measurements
    • Time Frame: 24 months
    • 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.
  • Circumference measurements
    • Time Frame: 36 months
    • 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.
  • Circumference measurements
    • Time Frame: 48 months
    • 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.
  • Circumference measurements
    • Time Frame: 60 months
    • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Castilla-La Mancha
  • Collaborator
    • Castilla-La Mancha Health Service
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Helena Romay Barrero, Prof. PhD., Principal Investigator, University of Castilla-La Mancha

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.