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Comparison of Techniques for Breast Cancer-Related Lymphedema.

Primary Purpose

Breast Cancer Lymphedema

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Complex Physical Therapy plus Pressotherapy
Kinesio Taping
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 Breast Cancer-Related Lymphedema, Complex Physical Therapy, Pressotherapy, Kinesio Taping, Physiotherapy, Manual Lymph Drainage, Multilayer Bandage, TTDL questionnaire

Eligibility Criteria

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

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).

Sites / Locations

  • Hospital Universitario 12 de Octubre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

CPT+P

Kinesio Taping

Arm Description

Complex Physical Therapy plus Pressotherapy during three weeks

Kinesio Taping during three weeks

Outcomes

Primary Outcome Measures

Changes in the volume difference between the upper limb with lymphedema and the healthy upper limb before and after treatment.
Truncated Cone Formula for Volume from upper limb circumference.

Secondary Outcome Measures

Score on the DASH Outcome Measure.
Validated questionnaire about Disability of the Arm,Shoulder and Hand.
Score of the TTDL questionnaire.
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).
Wong-Baker faces pain rating scale.
Stage of the lymphedema.
I, IIA, IIB III, IV.
Goniometry of Upper Limb.
Goniometry of shoulder, elbow and wrist.
Body Mass Index.
The weight in kilograms divided by the square of the height in metres (kg/m2).

Full Information

First Posted
February 8, 2017
Last Updated
February 13, 2019
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
NCT03051750
Brief Title
Comparison of Techniques for Breast Cancer-Related Lymphedema.
Official Title
Complex Physical Therapy Plus Pressotherapy Versus Kinesio Taping in Breast Cancer-Related Lymphedema. Randomized Crossover Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
February 1, 2016 (Actual)
Primary Completion Date
December 21, 2016 (Actual)
Study Completion Date
December 21, 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
This crossover study compares two different treatment techniques for Breast Cancer-Related Lymphedema: 1. Complex Physical Therapy plus Pressotherapy. 2. Kinesio Taping.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Lymphedema
Keywords
Breast Cancer-Related Lymphedema, Complex Physical Therapy, Pressotherapy, Kinesio Taping, Physiotherapy, Manual Lymph Drainage, Multilayer Bandage, TTDL questionnaire

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
3-month previous washout period; 3-week treatment phases; 3-month washout period between both treatment phases. Open design: it is impossible during the treatment to blind the physiotherapists and patients, due to the observable differences between both therapies both during their application and in the hours after their removal, by the marks that leave in the skin. Interventions: The two therapies compared are: CPT+ P. KT.
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
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CPT+P
Arm Type
Active Comparator
Arm Description
Complex Physical Therapy plus Pressotherapy during three weeks
Arm Title
Kinesio Taping
Arm Type
Experimental
Arm Description
Kinesio Taping during three weeks
Intervention Type
Other
Intervention Name(s)
Complex Physical Therapy plus Pressotherapy
Intervention Type
Other
Intervention Name(s)
Kinesio Taping
Primary Outcome Measure Information:
Title
Changes in the volume difference between the upper limb with lymphedema and the healthy upper limb before and after treatment.
Description
Truncated Cone Formula for Volume from upper limb circumference.
Time Frame
Four weeks during each treatment phase
Secondary Outcome Measure Information:
Title
Score on the DASH Outcome Measure.
Description
Validated questionnaire about Disability of the Arm,Shoulder and Hand.
Time Frame
Four weeks during each treatment phase
Title
Score of the TTDL questionnaire.
Description
a quality of life questionnaire for patients with breast cancer-related upper lymphedema using textile therapeutic device validated previously (not yet published).
Time Frame
Four weeks during each treatment phase
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
Stage of the lymphedema.
Description
I, IIA, IIB III, IV.
Time Frame
Four weeks during each treatment phase
Title
Goniometry of Upper Limb.
Description
Goniometry of shoulder, elbow and wrist.
Time Frame
Four weeks during each treatment phase
Title
Body Mass Index.
Description
The weight in kilograms divided by the square of the height in metres (kg/m2).
Time Frame
Four weeks during each treatment phase
Other Pre-specified Outcome Measures:
Title
Age.
Description
Years old at the beginning of the study.
Time Frame
First day of treatment of the first phase.
Title
Time since axillary surgery.
Description
Time since axillary surgery in years at the beginning of the study.
Time Frame
First day of treatment of the first phase.
Title
Type of axillary surgery.
Description
Lymphadenectomy or Sentinel Lymph Node Biopsy.
Time Frame
First day of treatment of the first phase.
Title
Type of breast surgery.
Description
Lumpectomy or mastectomy.
Time Frame
First day of treatment of the first phase.
Title
Radiotherapy for Breast Cancer.
Description
Yes or not.
Time Frame
First day of treatment of the first phase.
Title
Time since the appearance of the BCRL.
Description
Years since the BCRL appeared.
Time Frame
First day of treatment of the first phase.

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Submit BCRL Be a patient of the Breast Pathology Rehabilitation at Hospital Universitario 12 de Octubre. 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).
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
Citations:
PubMed Identifier
35642305
Citation
Pajero Otero V, Garcia Delgado E, Martin Cortijo C, Rodriguez Ramos ML, De Carlos Iriarte E, Gil Garcia A, Romay-Barrero H, Avendano-Coy J. Intensive complex physical therapy combined with intermittent pneumatic compression versus Kinesio taping for treating breast cancer-related lymphedema of the upper limb: A randomised cross-over clinical trial. Eur J Cancer Care (Engl). 2022 Sep;31(5):e13625. doi: 10.1111/ecc.13625. Epub 2022 May 31.
Results Reference
derived

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Comparison of Techniques for Breast Cancer-Related Lymphedema.

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