Comparison of Techniques for Breast Cancer-Related Lymphedema.

Overview

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

2. Kinesio Taping.

Full Title of Study: “Complex Physical Therapy Plus Pressotherapy Versus Kinesio Taping in Breast Cancer-Related Lymphedema. Randomized Crossover Trial.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: December 21, 2016

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.

Interventions

  • Other: Complex Physical Therapy plus Pressotherapy
  • Other: Kinesio Taping

Arms, Groups and Cohorts

  • Active Comparator: CPT+P
    • Complex Physical Therapy plus Pressotherapy during three weeks
  • Experimental: Kinesio Taping
    • Kinesio Taping during three weeks

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • Score on the DASH Outcome Measure.
    • Time Frame: Four weeks during each treatment phase
    • Validated questionnaire about Disability of the Arm,Shoulder and Hand.
  • 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).
  • 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.
  • Stage of the lymphedema.
    • Time Frame: Four weeks during each treatment phase
    • I, IIA, IIB III, IV.
  • Goniometry of Upper Limb.
    • Time Frame: Four weeks during each treatment phase
    • Goniometry of shoulder, elbow and wrist.
  • 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).

Participating in This Clinical Trial

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).

Gender Eligibility: Female

female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Violeta Pajero Otero
  • Collaborator
    • Hospital Universitario 12 de Octubre
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Violeta Pajero Otero, Physiotherapist at the Mammary Pathology Unit – Hospital Universitario 12 de Octubre
  • Overall Official(s)
    • Violeta Pajero Otero, MRes, Principal Investigator, Hospital Universitario 12 de Octubre

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