Comparison of Techniques for Breast Cancer-Related Lymphedema.

Breast Cancer Lymphedema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03051750
• Other study ID #: InveCuidRh150316
• Status: Completed
• Phase: N/A
• Start date: February 1, 2016
• Est. completion date: December 21, 2016

Study information

• Verified date: February 2019
• Source: Hospital Universitario 12 de Octubre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

2. Kinesio Taping.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: December 21, 2016
• Est. primary completion date: December 21, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Breast Cancer Lymphedema
• Breast Neoplasms
• Lymphedema

Intervention

Other:
• Complex Physical Therapy plus Pressotherapy

• Kinesio Taping

Locations

Country	Name	City	State
Spain	Hospital Universitario 12 de Octubre	Madrid

Sponsors (3)

Lead Sponsor	Collaborator
Violeta Pajero Otero	Hospital Universitario 12 de Octubre, University of Castilla-La Mancha

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Age.	Years old at the beginning of the study.	First day of treatment of the first phase.
Other	Time since axillary surgery.	Time since axillary surgery in years at the beginning of the study.	First day of treatment of the first phase.
Other	Type of axillary surgery.	Lymphadenectomy or Sentinel Lymph Node Biopsy.	First day of treatment of the first phase.
Other	Type of breast surgery.	Lumpectomy or mastectomy.	First day of treatment of the first phase.
Other	Radiotherapy for Breast Cancer.	Yes or not.	First day of treatment of the first phase.
Other	Time since the appearance of the BCRL.	Years since the BCRL appeared.	First day of treatment of the first phase.
Primary	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.	Four weeks during each treatment phase
Secondary	Score on the DASH Outcome Measure.	Validated questionnaire about Disability of the Arm,Shoulder and Hand.	Four weeks during each treatment phase
Secondary	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).	Four weeks during each treatment phase
Secondary	Symptoms associated with BCRL (pain, heaviness, pressure and hardness) using modified visual analogue scale (VAS).	Wong-Baker faces pain rating scale.	Four weeks during each treatment phase
Secondary	Stage of the lymphedema.	I, IIA, IIB III, IV.	Four weeks during each treatment phase
Secondary	Goniometry of Upper Limb.	Goniometry of shoulder, elbow and wrist.	Four weeks during each treatment phase
Secondary	Body Mass Index.	The weight in kilograms divided by the square of the height in metres (kg/m2).	Four weeks during each treatment phase