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 : October 22, 2020
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|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.|
|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 :||September 2021|
|Estimated Study Completion Date :||September 2021|
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)
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)
The maintenance phase is based on self-care and the use of compression garments.
- 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).
- 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.
- 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.
- 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).
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
|Contact: Antonio J Jiménez Vílchezfirstname.lastname@example.org|
|Contact: María N Muñoz Alcarazemail@example.com|
|Centro Periférico de Especialidades Castilla del Pino||Recruiting|
|Córdoba, Spain, 14011|
|Contact: María V Olmo Carmona|
|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.|