Kinesio Taping Versus Compression Garments for Breast Cancer-Related Lymphedema

NCT03051776 | Completed

• 1 other identifier: InveCuidRhKM
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Lymphedema

Keywords

Compression garments; Kinesio Taping; Breast Cancer-Related Lymphedema

Outcome Measures

Primary Outcomes (1)

• Estimated volumen of the upper limb.

  Truncated Cone Formula.

  Four weeks during each treatment phase

Secondary Outcomes (2)

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

  Four weeks during each treatment phase

• Goniometry of Upper Limb.

  Four weeks during each treatment phase

Study Arms (2)

Kinesio Taping

EXPERIMENTAL

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

Other: Kinesio Taping

Compression garment

ACTIVE COMPARATOR

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

Other: Compression Garment

Interventions

Kinesio Taping OTHER

Kinesio Taping

Compression Garment OTHER

Compression garment

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

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

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: 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.

Study Record Dates

• First Submitted: February 8, 2017
• First Posted: February 14, 2017
• Study Start: January 3, 2016
• Primary Completion: March 30, 2016
• Study Completion: March 30, 2016
• Last Updated: October 6, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)