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:
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 |
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 |
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)
|
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. |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contact: Antonio J Jiménez Vílchez | 957010122 | antonioj.jimenez.vilchez.sspa@juntadeandalucia.es | |
Contact: María N Muñoz Alcaraz | marian.munoz.sspa@juntadeandalucia.es |
Spain | |
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. |
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 |
|
|||||||||||||||
Original Primary Outcome Measures ICMJE | Same as current | |||||||||||||||
Change History | ||||||||||||||||
Current Secondary Outcome Measures ICMJE |
|
|||||||||||||||
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:
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:
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):
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 |
|
|||||||||||||||
Intervention ICMJE |
|
|||||||||||||||
Study Arms ICMJE |
|
|||||||||||||||
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 |
42 | |||||||||||||||
Original Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
|
|||||||||||||||
Sex/Gender ICMJE |
|
|||||||||||||||
Ages ICMJE | 14 Years to 70 Years (Child, Adult, Older Adult) | |||||||||||||||
Accepts Healthy Volunteers ICMJE | No | |||||||||||||||
Contacts ICMJE |
|
|||||||||||||||
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 |
|
|||||||||||||||
IPD Sharing Statement ICMJE |
|
|||||||||||||||
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 |
|
|||||||||||||||
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 |