Comparison of Techniques for Breast Cancer-Related Lymphedema.

NCT ID: NCT03051750

Last Updated: 2019-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-01
• Study Completion Date: 2016-12-21

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.

Conditions

Breast Cancer Lymphedema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

CPT+P

Complex Physical Therapy plus Pressotherapy during three weeks

Group Type: ACTIVE_COMPARATOR

Complex Physical Therapy plus Pressotherapy

Intervention Type: OTHER

Kinesio Taping

Kinesio Taping during three weeks

Group Type: EXPERIMENTAL

Kinesio Taping

Intervention Type: OTHER

Interventions

Complex Physical Therapy plus Pressotherapy

Intervention Type: OTHER

Kinesio Taping

Intervention Type: OTHER

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitario 12 de Octubre

OTHER

Sponsor Role: collaborator

University of Castilla-La Mancha

OTHER

Sponsor Role: collaborator

Violeta Pajero Otero

OTHER

Sponsor Role: lead

Responsible Party

Violeta Pajero Otero

Physiotherapist at the Mammary Pathology Unit

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Violeta Pajero Otero, MRes

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario 12 de Octubre

Locations

Hospital Universitario 12 de Octubre

Madrid, , Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 35642305 (View on PubMed)

Other Identifiers

InveCuidRh150316

Identifier Type: -

Identifier Source: org_study_id