4006-776-356 出国就医服务电话

免费获得国外相关药品,最快 1 个工作日回馈药物信息

出境医 / 临床实验 / New Therapeutic Approach in Upper Limb Lymphedema Secondary to Breast Cancer: Activity-oriented Proprioceptive Antiedema Therapy (TAPA)

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

Study Description
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 Show detailed description
Study Design
Layout table for study information
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 : September 2021
Estimated Study Completion Date : September 2021
Arms and Interventions
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.


Outcome Measures
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).


Eligibility Criteria
Layout table for eligibility information
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
Contacts and Locations

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

Locations
Layout table for location information
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
Layout table for investigator information
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.
Tracking Information
First Submitted Date  ICMJE November 23, 2018
First Posted Date  ICMJE December 3, 2018
Last Update Posted Date October 22, 2020
Actual Study Start Date  ICMJE March 1, 2019
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2018)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2018)
  • 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE New Therapeutic Approach in Upper Limb Lymphedema Secondary to Breast Cancer: Activity-oriented Proprioceptive Antiedema Therapy (TAPA)
Official Title  ICMJE New Therapeutic Approach in Upper Limb Lymphedema Secondary to Breast Cancer: Activity-oriented Proprioceptive Antiedema Therapy (TAPA). A Randomized Controlled Therapy
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.

Detailed Description

Lymphedema is defined as the abnormal accumulation of tissue proteins, which is accompanied of edema and chronic inflammation of a limb, so post-mastectomy lymphedema is one of the most serious sequelae of Breast Cancer (BC) that affects the quality of life of women operated for breast cancer. Its incidence is approximately between 6 and 30% of patients and its prevalence varies between 15-20%. It is considered a process without spontaneous resolution that involves the application of a palliative therapy conservative for life, with preventive measures to reduce it and prevent complications and an expected increase in the number of patients with lymphedema in the next years

Changes in work performance resulting from lymphedema vary from minor temporary changes to significant difficulties in the ADL, depending on the chronicity and severity of the affectation. It could affect physical components and psychological, as well as social and economic environment. In these limitations on activities and / or restrictions of participation, the Occupational Therapists (OT) provide a unique approach, since they are professionals specifically enabled for the use of the therapeutic potential of the activity and graduation of its control parameters in favor of the best occupational performance possible of the person. Furthermore, there are some research that support the inclusion of OT in the cancer rehabilitation and reveal a significant need for more research to explore ways in which the OT favorably influences the results of the cancer survivors.

The anamnesis, clinical exploration and complementary studies if necessary, allow us confirm the diagnosis of lymphedema, stage, possibilities of progression and approach the most indicated therapeutic in each case.

The conservative therapeutic of upper limb lymphoedema secondary to breast cancer plan includes preventive exercises and lifestyle habits, complete decongestive therapy (CDT) and compression garments.

The CDT comprises a series of measures, a first intensive phase consists of:

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

Despite the consensus of the experts in the evidence of decongestive therapy in lymphedema, there is still a lack of evidence to inform the optimal doses of treatment and the level of evidence about its efficacy in the treatment of lymphedema is only moderately strong, due to the scarcity of randomized trials with control group, well interventions controlled, accurate measures of volume, mobility or function and quality of life.

Likewise, the prescription of compression garments for lymphoedema is very varied and it may be due to the lack of underlying evidence to inform about the treatment. The evidence also suggests that the comprehensiveness and effectiveness of rehabilitation post-operative BC should also consider the self-control (empowerment) of patients, approaches to redesign the lifestyle and incorporate aspects of the promotion of health.

On the other hand, there are studies that confirm that women with lymphedema and pain after BC may present alterations in neural mechanosensitivity, neuropathic pain, as a result of nerve compression or peripheral neuropathy induced by chemotherapy and that it is worth conducting a clinical trial to evaluate the techniques of Neural mobilization (NM) oriented to the functionality of upper extremities, supporting the clinical mechanism of NM in the reduction of intraneural edema.

Published research suggests incorporating proprioceptive neuromuscular facilitation (PNF) with the traditional NM method, to facilitate the process of treatment for patients with lymphoedema, because it induces powerful synergistic effects on the volume of edema, range of motion (ROM) of the shoulder, pain and depression. That treatment independently or in combination with laser also improves these variables and even the speed of blood circulation in the armpit. Furthermore, in a study in which bandaging could not be used and CDT was combined with PNF and respiration, reducing lymphedema and improving ROM too, which could improve performance of activities, level of participation and, therefore, quality of life.

There are research supporting use of Coban®3M bandage as early start of pressotherapy in the rehabilitation treatment of lymphedema to reduce prolonged edema (agent cause of multiple complications and functional loss), we consider the possibility of testing the efficacy of a bandage with similar characteristics, in terms of elasticity and self-adherence, more economical, applying it from distal to proximal, with a low level of compression, in order to provide proprioceptive information, but avoiding compressive syndrome, reducing pain and edema and improving the performance of ADL through the practice of them. It consists in only two thin layers and it is fast (10 minutes) and simple placement (can be self-administered by the patient and / or caregiver), improving cost- effectiveness of treatments combined with three other techniques whose evidence has been previously reviewed. We have agreed to call this therapy we propose in this study Activity-oriented Proprioceptive Antiedema Therapy (TAPA in Spanish):

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

Given the consensus of the CDT as a gold standard treatment in lymphedema, we consider that our experimental treatment TAPA should make the comparison with it. So, half of patients will receive TAPA treatment while the other half will receive CDT standard treatment.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Breast Cancer Lymphedema
  • Post-Mastectomy Secondary Lymphedema
Intervention  ICMJE
  • 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.
  • 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.

Study Arms  ICMJE
  • 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)
    Intervention: 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).
    Intervention: Other: Complete Decongestive Therapy (CDT)
Publications * Muñoz-Alcaraz MN, Pérula-de-Torres LÁ, Serrano-Merino J, Jiménez-Vílchez AJ, Olmo-Carmona MV, Muñoz-García MT, Bartolomé-Moreno C, Oliván-Blázquez B, Magallón-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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 26, 2019)
42
Original Estimated Enrollment  ICMJE
 (submitted: November 30, 2018)
70
Estimated Study Completion Date  ICMJE September 2021
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: It consists in women with upper limb lymphedema secondary to breast cancer
Ages  ICMJE 14 Years to 70 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Antonio J Jiménez Vílchez 957010122 antonioj.jimenez.vilchez.sspa@juntadeandalucia.es
Contact: María N Muñoz Alcaraz marian.munoz.sspa@juntadeandalucia.es
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03762044
Other Study ID Numbers  ICMJE Lymphedema Rehabilitation
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Responsible Party Antonio José Jiménez Vílchez, Hospital Universitario Reina Sofia de Cordoba
Study Sponsor  ICMJE Hospital Universitario Reina Sofia de Cordoba
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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.
PRS Account Hospital Universitario Reina Sofia de Cordoba
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

治疗医院