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Completed

NCT Number: NCT04112966

Lymphedema Prevention in Breast Cancer

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Provincial Hospital

Toledo, 45006, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

14 sessions of manual lymphatic drainage technique

Procedure

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

Other

The health education for lymphedema prevention.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

University of Castilla-La Mancha

Other

Collaborators

  • Castilla-La Mancha Health Service

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2011
Study completion
2016
First posted
Oct 2, 2019
Registry last updated
Oct 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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