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

NCT03762044 | Completed

• 1 other identifier: Lymphedema Rehabilitation
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Lymphedema; Post-Mastectomy Secondary Lymphedema

Keywords

Breast Cancer; Breast Cancer Lymphedema; Post-Mastectomy Secondary Lymphedema; Occupational Therapy; Proprioceptive Neuromuscular Facilitation; Neural Mobilization

Outcome Measures

Primary Outcomes (2)

• Volume

  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).

  Baseline and 5 weeks

• Circometry

  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.

  Baseline and 5 weeks

Secondary Outcomes (2)

• Quick Disabilities of the Arm, Shoulder and Hand (Quick DASH)

  Baseline and 5 weeks

• Upper Limb Lymphedema 27 (ULL-27)

  Baseline and 5 weeks

Study Arms (2)

Activity-oriented Proprioceptive Antiedema Therapy (TAPA)

EXPERIMENTAL

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)

Complete Decongestive Therapy (CDT)

ACTIVE COMPARATOR

10 sessions of 30 minutes, twice a week in a total 5 week period of complete decongestive therapy (CDT).

Other: Complete Decongestive Therapy (CDT)

Interventions

Activity-oriented Proprioceptive Antiedema Therapy (TAPA) OTHER

* Health education / patient empowerment. * Neurodynamic activities oriented to ADL. * Proprioceptive neuromuscular facilitation exercises oriented to ADL. * Self-adherent self-adhesive antiedema of low compression.

Activity-oriented Proprioceptive Antiedema Therapy (TAPA)

Complete Decongestive Therapy (CDT) OTHER

* Skin care. * Kinesitherapy * Manual lymphatic drainage (MLD) * Multilayer bandage. The maintenance phase is based on self-care and the use of compression garments.

Complete Decongestive Therapy (CDT)

Eligibility Criteria

• Age: 14 Years - 70 Years
• Gender Eligibility Details: It consists in women with upper limb lymphedema secondary to breast cancer
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Universitario Reina Sofia de Cordoba: lead

Study Sites (1)

Centro Periférico de Especialidades Castilla del Pino

Córdoba, 14011, Spain

Location

Related Publications (1)

• Munoz-Alcaraz MN, Perula-de-Torres LA, Serrano-Merino J, Jimenez-Vilchez AJ, Olmo-Carmona MV, Munoz-Garcia MT, Bartolome-Moreno C, Olivan-Blazquez B, Magallon-Botaya R. Efficacy and efficiency of a new therapeutic approach based on activity-oriented proprioceptive antiedema therapy (TAPA) for edema reduction and improved occupational performance in the rehabilitation of breast cancer-related arm lymphedema in women: a controlled, randomized clinical trial. BMC Cancer. 2020 Nov 9;20(1):1074. doi: 10.1186/s12885-020-07558-x.

  PMID: 33167921 DERIVED

MeSH Terms

Conditions

Breast Cancer Lymphedema; Breast Neoplasms

Interventions

tapasin

Condition Hierarchy (Ancestors)

Lymphedema; Lymphatic Diseases; Hemic and Lymphatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• 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.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Medicine & Rehabilitation Hospital Resident

Model Details: 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.

Study Record Dates

• First Submitted: November 23, 2018
• First Posted: December 3, 2018
• Study Start: March 1, 2019
• Primary Completion: September 1, 2021
• Study Completion: February 1, 2022
• Last Updated: September 22, 2023

Record last verified: 2023-09

Locations

ES (1)