Kinesio Taping Versus Compression Garments for Breast Can... | NCT03051776

Studies
Kinesio Taping Versus Compression Garments for Breast Cancer-Related Lymphedema

NCT03051776

Sponsor

Violeta Pajero Otero

Status

Completed

Last Update Posted

Oct 6, 2017Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Breast Cancer Lymphedema

Interventions

Kinesio Taping
Compression Garment

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 3, 2016Actual

Primary Completion Date

Mar 30, 2016Actual

Completion Date

Mar 30, 2016Actual

First Submitted Date

Feb 8, 2017

First Submission Date that Met QC Criteria

Feb 9, 2017

First Posted Date

Feb 14, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 5, 2017

Last Update Posted Date

Oct 6, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Violeta Pajero Otero, Physiotherapist at the Mammary Pathology Unit, Hospital Universitario 12 de OctubreSponsor-Investigator

Lead Sponsor

Violeta Pajero OteroOTHER

Collaborators

Name	Class
Hospital Universitario 12 de Octubre	OTHER
University of Castilla-La Mancha	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Kinesio Taping	Other		Kinesio Taping
Compression Garment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Estimated volumen of the upper limb.	Truncated Cone Formula.	Four weeks during each treatment phase

Secondary Outcomes

Measure	Description	Time Frame
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
Goniometry of Upper Limb.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Violeta Pajero Otero, MRes	Hospital Universitario 12 de Octubre	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Universitario 12 de Octubre		Madrid		28041	Spain

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000072656	Breast Cancer Lymphedema

Ancestor Terms

ID	Term
D008209	Lymphedema
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases
D011183	Postoperative Complications

Browse Leaves

Not provided

Browse Branches

Not provided

Masking Info

Masking

Single

Masking Description

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.

Who Masked

Outcomes Assessor