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Kinesio Taping Versus Compression Garments for Breast Cancer-Related Lymphedema

Primary Purpose

Breast Cancer Lymphedema

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Kinesio Taping
Compression Garment
Sponsored by
Violeta Pajero Otero
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer Lymphedema focused on measuring Compression garments, Kinesio Taping, Breast Cancer-Related Lymphedema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Suffering from clinically significant breast cancer-related lymphedema at least since three months ago.
  2. Having a Compression Garment suitable for the lymphedema arm

Exclusion Criteria:

  1. Physiotherapy treatment for lymphedema during the 4 weeks before study start (pre-wash phase).
  2. Metastasis breast cancer or other tumour.
  3. Treated with systemic chemotherapy and /or radiotherapy at that time
  4. Heart Failure or Renal Failure.
  5. Using Diuretics.
  6. Bilateral axillary lymphadenectomy.
  7. Cognitive impairment or delay that impedes understanding the study's instructions.

Sites / Locations

  • Hospital Universitario 12 de Octubre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Kinesio Taping

Compression garment

Arm Description

It was done a four week phase with Kinesio Taping in the arm affected with lymphedema.

It was done a four week phase with Compression garment in the arm affected with lymphedema.

Outcomes

Primary Outcome Measures

Estimated volumen of the upper limb.
Truncated Cone Formula.

Secondary Outcome Measures

Symptoms associated with BCRL (pain, heaviness, pressure and hardness) using modified visual analogue scale (VAS).
Wong-Baker faces pain rating scale.
Goniometry of Upper Limb.
Goniometry of shoulder, elbow, wrist and hand.

Full Information

First Posted
February 8, 2017
Last Updated
October 5, 2017
Sponsor
Violeta Pajero Otero
Collaborators
Hospital Universitario 12 de Octubre, University of Castilla-La Mancha
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1. Study Identification

Unique Protocol Identification Number
NCT03051776
Brief Title
Kinesio Taping Versus Compression Garments for Breast Cancer-Related Lymphedema
Official Title
Kinesio Taping Versus Compression Garments in the Treatment of Breast Cancer-Related Lymphedema. Randomized Crossover Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
January 3, 2016 (Actual)
Primary Completion Date
March 30, 2016 (Actual)
Study Completion Date
March 30, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Violeta Pajero Otero
Collaborators
Hospital Universitario 12 de Octubre, University of Castilla-La Mancha

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Breast cancer-related lymphedema (BCRL) tends to become chronic and progressive. Current therapies have modest results for this condition. Compression garments (CG) prevent the worsening of lymphedema and even improve it, during periods between treatments of physical therapy. Kinesio Taping(KT) is being recently used for lymphedema, although little evidence backs it. The aim of this study is to compare the reduction of lymphedema volume with both therapies.
Detailed Description
Primary end points: to evaluate whether the decrease in BCRL volume is different for a 4-week treatment with KT than with CG. Research design: Randomized quasi-experimental clinical pilot study: initial sample randomly balanced into two groups . The initial sample was selected among the patients of "Breast Pathology Rehabilitation" at Hospital Universitario 12 de Octubre . The planned sample size was 30. Cross Design: it made possible to evaluate two different treatments in the same patient, cancelling intragroup variability. Open design: it was impossible to blind patients and physiotherapist researcher because of patent visual differences between the two therapies, CG or KT, both during application and while being worn, and even in the hours after its removal, due to the marks left on the skin. However, at least one external evaluator suitably trained was implemented and performed the randomisation of the groups and collected all patient data. Statistical study was also made by others (staff of the "Clinique Investigation Unit (i+12)" of Hospital Universitario 12 de Octubre) with coded variables to blind the analyst.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Lymphedema
Keywords
Compression garments, Kinesio Taping, Breast Cancer-Related Lymphedema

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Two treatmet phases, with a four week wash out period bewtween them: A four week phase with Kinesio Taping A four week phase with compression garments.
Masking
Outcomes Assessor
Masking Description
The statistical analysis will be supervised by staff of the Scientific Support Unit: Epidemiology and Biostatistics (i+12), Hospital Universitario 12 de Octubre with the variables coded to blind the analyst.
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Kinesio Taping
Arm Type
Experimental
Arm Description
It was done a four week phase with Kinesio Taping in the arm affected with lymphedema.
Arm Title
Compression garment
Arm Type
Active Comparator
Arm Description
It was done a four week phase with Compression garment in the arm affected with lymphedema.
Intervention Type
Other
Intervention Name(s)
Kinesio Taping
Intervention Type
Other
Intervention Name(s)
Compression Garment
Primary Outcome Measure Information:
Title
Estimated volumen of the upper limb.
Description
Truncated Cone Formula.
Time Frame
Four weeks during each treatment phase
Secondary Outcome Measure Information:
Title
Symptoms associated with BCRL (pain, heaviness, pressure and hardness) using modified visual analogue scale (VAS).
Description
Wong-Baker faces pain rating scale.
Time Frame
Four weeks during each treatment phase
Title
Goniometry of Upper Limb.
Description
Goniometry of shoulder, elbow, wrist and hand.
Time Frame
Four weeks during each treatment phase

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Suffering from clinically significant breast cancer-related lymphedema at least since three months ago. Having a Compression Garment suitable for the lymphedema arm Exclusion Criteria: Physiotherapy treatment for lymphedema during the 4 weeks before study start (pre-wash phase). Metastasis breast cancer or other tumour. Treated with systemic chemotherapy and /or radiotherapy at that time Heart Failure or Renal Failure. Using Diuretics. Bilateral axillary lymphadenectomy. Cognitive impairment or delay that impedes understanding the study's instructions.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Violeta Pajero Otero, MRes
Organizational Affiliation
Hospital Universitario 12 de Octubre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

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Kinesio Taping Versus Compression Garments for Breast Cancer-Related Lymphedema

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