Clinical trial NCT03051776: Kinesio Taping Versus Compression Garments for Breast Cancer-Related Lymphedema
Official title: Kinesio Taping Versus Compression Garments in the Treatment of Breast Cancer-Related Lymphedema. Randomized Crossover Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Lymphedema
Keywords: Compression garments
Kinesio Taping
Breast Cancer-Related Lymphedema
Lead sponsor: Hospital Universitario 12 de Octubre
Sponsor class: OTHER
Collaborators: name: Hospital Universitario 12 de Octubre
name: University of Castilla-La Mancha
First posted: 2017-02-14
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: Primary end points: to evaluate whether the decrease in BCRL volume is different for a 4-week treatment with KT than with CG.

Research design:

Randomized quasi-experimental clinical pilot study: initial sample randomly balanced into two groups . The initial sample was selected among the patients of "Breast Pathology Rehabilitation" at Hospital Universitario 12 de Octubre . The planned sample size was 30.

Cross Design: it made possible to evaluate two different treatments in the same patient, cancelling intragroup variability.

Open design: it was impossible to blind patients and physiotherapist researcher because of patent visual differences between the two therapies, CG or KT, both during application and while being worn, and even in the hours after its removal, due to the marks left on the skin. However, at least one external evaluator suitably trained was implemented and performed the randomisation of the groups and collected all patient data. Statistical study was also made by others (staff of the "Clinique Investigation Unit (i+12)" of Hospital Universitario 12 de Octubre) with coded variables to blind the analyst.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Physiotherapy treatment for lymphedema during the 4 weeks before study start (pre-wash phase).
2. Metastasis breast cancer or other tumour.
3. Treated with systemic chemotherapy and /or radiotherapy at that time
4. Heart Failure or Renal Failure.
5. Using Diuretics.
6. Bilateral axillary lymphadenectomy.
7. Cognitive impairment or delay that impedes understanding the study's instructions.

Primary outcomes:
measure: Estimated volumen of the upper limb.
timeFrame: Four weeks during each treatment phase
Secondary outcomes:
measure: Symptoms associated with BCRL (pain, heaviness, pressure and hardness) using modified visual analogue scale (VAS).
timeFrame: Four weeks during each treatment phase
measure: Goniometry of Upper Limb.
timeFrame: Four weeks during each treatment phase
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
Study officials:
affiliation: Hospital Universitario 12 de Octubre
name: Violeta Pajero Otero, MRes
role: PRINCIPAL_INVESTIGATOR
References: