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Trial record 7 of 129 for:    lymphedema | Recruiting, Not yet recruiting, Available Studies

New Therapeutic Approach in Upper Limb Lymphedema Secondary to Breast Cancer: Activity-oriented Proprioceptive Antiedema Therapy (TAPA)

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ClinicalTrials.gov Identifier: NCT03762044
Recruitment Status : Recruiting
First Posted : December 3, 2018
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Antonio José Jiménez Vílchez, Hospital Universitario Reina Sofia de Cordoba

Brief Summary:

This study evaluates the effectiveness of an experimental proposal therapy for upper limb lymphedema secondary to breast called Activity-oriented proprioceptive antiedema therapy (TAPA) facing the consensual gold standard treatment, the complete decongestive therapy. TAPA consists in:

  • Health education / patient empowerment.
  • Neurodynamic activities oriented to Activities of Daily Living (ADL).
  • Proprioceptive neuromuscular facilitation exercises oriented to ADL.
  • Self-adherent self-adhesive antiedema of low compression.

Half of patients will receive TAPA treatment while the other half will receive CDT standard treatment.


Condition or disease Intervention/treatment Phase
Breast Cancer Lymphedema Post-Mastectomy Secondary Lymphedema Other: Activity-oriented Proprioceptive Antiedema Therapy (TAPA) Other: Complete Decongestive Therapy (CDT) Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: After proposing to the subjects the enrollment to the study and once they accept, they will be randomly allocated to experimental TAPA treatment group or standard CDT treatment. They will be assessed 1 to 3 days before and after completing the treatment. It will be consists in a total of 10 sessions of 30 minutes of treatment, twice per week in a total 5 weeks period.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: In order to masking, investigator who assess the subject before and after the treatment will not know which group the subjects belong, and so the biostatistician.
Primary Purpose: Treatment
Official Title: New Therapeutic Approach in Upper Limb Lymphedema Secondary to Breast Cancer: Activity-oriented Proprioceptive Antiedema Therapy (TAPA). A Randomized Controlled Therapy
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Activity-oriented Proprioceptive Antiedema Therapy (TAPA)
10 sessions of 30 minutes, twice a week in a total 5 week period of Activity-oriented Proprioceptive Antiedema Therapy (TAPA in Spanish)
Other: Activity-oriented Proprioceptive Antiedema Therapy (TAPA)
  • Health education / patient empowerment.
  • Neurodynamic activities oriented to ADL.
  • Proprioceptive neuromuscular facilitation exercises oriented to ADL.
  • Self-adherent self-adhesive antiedema of low compression.

Active Comparator: Complete Decongestive Therapy (CDT)
10 sessions of 30 minutes, twice a week in a total 5 week period of complete decongestive therapy (CDT).
Other: Complete Decongestive Therapy (CDT)
  • Skin care.
  • Kinesitherapy
  • Manual lymphatic drainage (MLD)
  • Multilayer bandage.

The maintenance phase is based on self-care and the use of compression garments.





Primary Outcome Measures :
  1. Volume [ Time Frame: Baseline and 5 weeks ]
    Volume of the upper limb lymphedema using the Kuhnke formula (Vol=(C1^2+C2^2+...Cn^2)/π). It allows you to assess the volume difference between the affected limb and the healthy one. According to the Working Group of the XI International Lymphology Congress, lymphedema are classified in grade I (mild) ( 10-25% difference), grade II (moderate) (26-50% difference) and grade III (severe) (>51% difference).

  2. Circometry [ Time Frame: Baseline and 5 weeks ]
    Perimeter of upper limb lymphedema using a measuring tape in seven spots: Metacarpophalangeal, 5 and 10cm over radial styloid, 5cm under lateral epicondyle and 5, 10 and 15cm over lateral epicondyle. It is significative when there is a 2cm difference between the healthy and affected limb.


Secondary Outcome Measures :
  1. Quick Disabilities of the Arm, Shoulder and Hand (Quick DASH) [ Time Frame: Baseline and 5 weeks ]
    Upper limp function for development of activities using the Quick Disabilities of the Arm, Shoulder and Hand (Quick DASH), which consists in eleven questions. 10 out of 11 eleven questions must be answered. All the answers are added and divided by the number of questions answered. Then, subtract 1 and multiply by 25. The higher the score, the greater the disability.

  2. Upper Limb Lymphedema 27 (ULL-27) [ Time Frame: Baseline and 5 weeks ]
    Quality of life in a questionnaire specific to patients with upper limb lymphedema secondary to breast cancer called Upper Limb Lymphedema 27 (ULL-27). The ULL-27 is a self-report questionnaire encompassing 27 questions with answers given on a 5-point Likert scale, ranging from "never" to "always" and is considered to measure the effects of lymphedema on health related quality of life. The questionnaire measures three domains: physical (15 items), psychological (7 items) and social (5 items), with scores ranging from 0 to 100 (100 being the best score possible).



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   It consists in women with upper limb lymphedema secondary to breast cancer
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Upper limb lymphedema secondary to breast cancer grade I and II, according to the Working Group of the XI International Lymphology Congress

Exclusion Criteria:

  • Upper limb lymphedema secondary to breast cancer grade 0 and III, according to the Working Group of the XI International Lymphology Congress

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03762044


Contacts
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Contact: Antonio J Jiménez Vílchez 957010122 antonioj.jimenez.vilchez.sspa@juntadeandalucia.es
Contact: María N Muñoz Alcaraz marian.munoz.sspa@juntadeandalucia.es

Locations
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Spain
Centro Periférico de Especialidades Castilla del Pino Recruiting
Córdoba, Spain, 14011
Contact: María V Olmo Carmona         
Sponsors and Collaborators
Hospital Universitario Reina Sofia de Cordoba
Investigators
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Principal Investigator: María N Muñoz Alcaraz Distrito Sanitario Córdoba Guadalquivir. Servicio Andaluz de Salud.
Principal Investigator: María V Olmo Carmona UGC de Medicina Física y Rehabilitación IN. Hospital Universitario Reina Sofía
Principal Investigator: Antonio J Jiménez Vílchez UGC de Medicina Física y Rehabilitación IN. Hospital Universitario Reina Sofía
Principal Investigator: Luis A Pérula de Torres Unidad Docente de Medicina Familiar y Comunitaria de Córdoba
Principal Investigator: Jesús Serrano Merino Distrito Sanitario Córdoba Guadalquivir. Servicio Andaluz de Salud.

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Responsible Party: Antonio José Jiménez Vílchez, Physical Medicine & Rehabilitation Hospital Resident, Hospital Universitario Reina Sofia de Cordoba
ClinicalTrials.gov Identifier: NCT03762044     History of Changes
Other Study ID Numbers: Lymphedema Rehabilitation
First Posted: December 3, 2018    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: We are still developing the documents, we haven't decided yet if we are going to share them

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Antonio José Jiménez Vílchez, Hospital Universitario Reina Sofia de Cordoba:
Breast Cancer
Breast Cancer Lymphedema
Post-Mastectomy Secondary Lymphedema
Occupational Therapy
Proprioceptive Neuromuscular Facilitation
Neural Mobilization

Additional relevant MeSH terms:
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Lymphedema
Breast Cancer Lymphedema
Breast Neoplasms
Neoplasm Metastasis
Postoperative Complications
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Lymphatic Diseases