Comparison of Techniques for Breast Cancer-Related Lymphedema.

NCT03051750 | Completed

• 1 other identifier: InveCuidRh150316
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

This crossover study compares two different treatment techniques for Breast Cancer-Related Lymphedema: 1. Complex Physical Therapy plus Pressotherapy. 2\. Kinesio Taping.

Conditions

Breast Cancer Lymphedema

Keywords

Breast Cancer-Related Lymphedema; Complex Physical Therapy; Pressotherapy; Kinesio Taping; Physiotherapy; Manual Lymph Drainage; Multilayer Bandage; TTDL questionnaire

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Score on the DASH Outcome Measure.

  Four weeks during each treatment phase

• Score of the TTDL questionnaire.

  Four weeks during each treatment phase

• Symptoms associated with BCRL (pain, heaviness, pressure and hardness) using modified visual analogue scale (VAS).

  Four weeks during each treatment phase

• Stage of the lymphedema.

  Four weeks during each treatment phase

• Goniometry of Upper Limb.

  Four weeks during each treatment phase

Other Outcomes (6)

• Age.

  First day of treatment of the first phase.

• Time since axillary surgery.

  First day of treatment of the first phase.

• Type of axillary surgery.

  First day of treatment of the first phase.

Study Arms (2)

CPT+P

ACTIVE COMPARATOR

Complex Physical Therapy plus Pressotherapy during three weeks

Other: Complex Physical Therapy plus Pressotherapy

Kinesio Taping

EXPERIMENTAL

Kinesio Taping during three weeks

Other: Kinesio Taping

Interventions

Complex Physical Therapy plus Pressotherapy OTHER

CPT+P

Kinesio Taping OTHER

Kinesio Taping

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Submit BCRL
• Be a patient of the Breast Pathology Rehabilitation at Hospital Universitario 12 de Octubre.
• Signing the informed consent.

You may not qualify if:

• \) 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.
• \) Have performed treatment for BCRL during the 3 months prior to the start of the study (previous washing phase).

Sponsors & Collaborators

• Violeta Pajero Otero: lead
• Hospital Universitario 12 de Octubre: collaborator
• University of Castilla-La Mancha: collaborator

Study Sites (1)

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Related Publications (1)

• 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.

  PMID: 35642305 DERIVED

MeSH Terms

Conditions

Breast Cancer Lymphedema

Condition Hierarchy (Ancestors)

Lymphedema; Lymphatic Diseases; Hemic and Lymphatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Violeta Pajero Otero, MRes

  Hospital Universitario 12 de Octubre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physiotherapist at the Mammary Pathology Unit

Model Details: 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.

Study Record Dates

• First Submitted: February 8, 2017
• First Posted: February 14, 2017
• Study Start: February 1, 2016
• Primary Completion: December 21, 2016
• Study Completion: December 21, 2016
• Last Updated: February 15, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)