Comparison of Techniques for Breast Cancer-Related Lymphedema.

February 13, 2019 updated by: Violeta Pajero Otero

Complex Physical Therapy Plus Pressotherapy Versus Kinesio Taping in Breast Cancer-Related Lymphedema. Randomized Crossover Trial.

This crossover study compares two different treatment techniques for Breast Cancer-Related Lymphedema: 1. Complex Physical Therapy plus Pressotherapy.

2. Kinesio Taping.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Breast Cancer-Related Lymphedema (BCRL) tends to progress in stage and grade if it is not treated.

Complex Physical Therapy (CPT), that includes Manual Lymph Drainage + Multilayer Bandage + Self-care, is the most used technique in order to join the benefits of each technique by the lack of great results with only one technique. The most volume reduction found in a study was achieved combining CPT and Pressotherapy(P). On the other hand, the use of Kinesio Taping (KT) for BCRL has been spreading lately although its clinical efficacy has not been determined by high quality studies.

GOALS:

Main objective: To analyze the effectiveness in the reduction of BCRL volume with KT versus CPT+P in patients attended at the rehabilitation service at HU12Octubre.

Secondary objectives:

To analyze possible changes after each therapy in:

  • DASH (Disability Arm, Shoulder and Hand) outcome measure score.
  • TTDL (textile therapeutic device for lymphedema) questionnaire score (a quality of life questionnaire for patients with breast cancer-related upper lymb lymphedema using textile therapeutic device that has been validated previously).
  • Symptoms associated with BCRL (pain, heaviness, pressure and hardness) using visual analogue scale (VAS).
  • Goniometry of Upper Limb.

METHODOLOGY OF THE STUDY:

Design: crossover trial, with a 3-month washout period between both treatment phases. Open design: it is impossible during the treatment to blind physiotherapists and patients, due to the observable differences between both therapies neither during their application nor in the hours after their removal, by the marks left in the skin. The statistical analysis will be supervised by staff of the Clinical Research Unit-Clinical Trials (i+12) of HU12Octubre with the variables coded to blind the analyst.

Interventions: The two therapies compared are:

  • CPT+ P.
  • KT. Sample size: a sample of 50 patients (25 in each group) was calculated. Subjects of study and randomization: An initial computerized randomized sample was generated among the patients who had attended the Breast Pathology Rehabilitation visit at HU12Octubre during the previous year and who met the eligibility criteria and they were randomly assigned to the groups.

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28041
        • Hospital Universitario 12 De Octubre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Submit BCRL
  2. Be a patient of the Breast Pathology Rehabilitation at Hospital Universitario 12 de Octubre.
  3. Signing the informed consent.

Exclusion Criteria:

1) Breast Cancer metastasis or other active tumor. 2) Intravenous chemotherapy or radiotherapy actually. 3) Heart or kidney failure. 4) Use diuretics. 5) active infection (erysipelas) or any cutaneous disease in UL or back. 5) Bilateral lymphadenectomy. 6) present deterioration or cognitive delay that would prevent understanding instructions and purpose of the study.

7) Have performed treatment for BCRL during the 3 months prior to the start of the study (previous washing phase).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: CPT+P
Complex Physical Therapy plus Pressotherapy during three weeks
Other: Complex Physical Therapy plus Pressotherapy
EXPERIMENTAL: Kinesio Taping
Kinesio Taping during three weeks
Other: Kinesio Taping

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in the volume difference between the upper limb with lymphedema and the healthy upper limb before and after treatment.
Time Frame: Four weeks during each treatment phase
Truncated Cone Formula for Volume from upper limb circumference.
Four weeks during each treatment phase

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptoms associated with BCRL (pain, heaviness, pressure and hardness) using modified visual analogue scale (VAS).
Time Frame: Four weeks during each treatment phase
Wong-Baker faces pain rating scale.
Four weeks during each treatment phase
Score on the DASH Outcome Measure.
Time Frame: Four weeks during each treatment phase
Validated questionnaire about Disability of the Arm,Shoulder and Hand.
Four weeks during each treatment phase
Score of the TTDL questionnaire.
Time Frame: Four weeks during each treatment phase
a quality of life questionnaire for patients with breast cancer-related upper lymphedema using textile therapeutic device validated previously (not yet published).
Four weeks during each treatment phase
Stage of the lymphedema.
Time Frame: Four weeks during each treatment phase
I, IIA, IIB III, IV.
Four weeks during each treatment phase
Goniometry of Upper Limb.
Time Frame: Four weeks during each treatment phase
Goniometry of shoulder, elbow and wrist.
Four weeks during each treatment phase
Body Mass Index.
Time Frame: Four weeks during each treatment phase
The weight in kilograms divided by the square of the height in metres (kg/m2).
Four weeks during each treatment phase

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Age.
Time Frame: First day of treatment of the first phase.
Years old at the beginning of the study.
First day of treatment of the first phase.
Time since axillary surgery.
Time Frame: First day of treatment of the first phase.
Time since axillary surgery in years at the beginning of the study.
First day of treatment of the first phase.
Type of axillary surgery.
Time Frame: First day of treatment of the first phase.
Lymphadenectomy or Sentinel Lymph Node Biopsy.
First day of treatment of the first phase.
Type of breast surgery.
Time Frame: First day of treatment of the first phase.
Lumpectomy or mastectomy.
First day of treatment of the first phase.
Radiotherapy for Breast Cancer.
Time Frame: First day of treatment of the first phase.
Yes or not.
First day of treatment of the first phase.
Time since the appearance of the BCRL.
Time Frame: First day of treatment of the first phase.
Years since the BCRL appeared.
First day of treatment of the first phase.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Violeta Pajero Otero

Collaborators

Hospital Universitario 12 de Octubre
University of Castilla-La Mancha

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2016

Primary Completion (ACTUAL)

December 21, 2016

Study Completion (ACTUAL)

December 21, 2016

Study Registration Dates

First Submitted

February 8, 2017

First Submitted That Met QC Criteria

February 9, 2017

First Posted (ACTUAL)

February 14, 2017

Study Record Updates

Last Update Posted (ACTUAL)

February 15, 2019

Last Update Submitted That Met QC Criteria

February 13, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • InveCuidRh150316

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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