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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT03051776
Date of registration: 08/02/2017
Prospective Registration: No
Primary sponsor: Violeta Pajero Otero
Public title: Kinesio Taping Versus Compression Garments for Breast Cancer-Related Lymphedema
Scientific title: Kinesio Taping Versus Compression Garments in the Treatment of Breast Cancer-Related Lymphedema. Randomized Crossover Trial.
Date of first enrolment: January 3, 2016
Target sample size: 30
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT03051776
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).  
Phase:  N/A
Countries of recruitment
Spain
Contacts
Name:     Violeta Pajero Otero, MRes
Address: 
Telephone:
Email:
Affiliation:  Hospital Universitario 12 de Octubre
Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Female
Health Condition(s) or Problem(s) studied
Breast Cancer Lymphedema
Intervention(s)
Other: Compression Garment
Other: Kinesio Taping
Primary Outcome(s)
Estimated volumen of the upper limb. [Time Frame: Four weeks during each treatment phase]
Secondary Outcome(s)
Goniometry of Upper Limb. [Time Frame: Four weeks during each treatment phase]
Symptoms associated with BCRL (pain, heaviness, pressure and hardness) using modified visual analogue scale (VAS). [Time Frame: Four weeks during each treatment phase]
Secondary ID(s)
InveCuidRhKM
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Hospital Universitario 12 de Octubre
University of Castilla-La Mancha
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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