Breast Cancer LymphedemaNCT03762044
New Therapeutic Approach in Upper Limb Lymphedema Secondary to Breast Cancer: Activity-oriented Proprioceptive Antiedema Therapy (TAPA)
A study testing Activity-oriented Proprioceptive Antiedema Therapy (TAPA) and Complete Decongestive Therapy (CDT) in people with Breast Cancer Lymphedema and Post-Mastectomy Secondary Lymphedema, run by Hospital Universitario Reina Sofia de Cordoba at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 70 years, women only
- Conditions the study is for
- Breast Cancer Lymphedema, Post-Mastectomy Secondary Lymphedema
- What is being tested?
- Activity-oriented Proprioceptive Antiedema Therapy (TAPA) and Complete Decongestive Therapy (CDT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2019to 1 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 70 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Upper limb lymphedema secondary to breast cancer grade I and II, according to the Working Group of the XI International Lymphology Congress
Who cannot join
- Upper limb lymphedema secondary to breast cancer grade 0 and III, according to the Working Group of the XI International Lymphology Congress
Trial locations and contacts
1 site in 1 country.
Spain1 site
Centro Periférico de Especialidades Castilla del Pino
Córdoba, 14011
About this study
Official title: New Therapeutic Approach in Upper Limb Lymphedema Secondary to Breast Cancer: Activity-oriented Proprioceptive Antiedema Therapy (TAPA). A Randomized Controlled Therapy
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.
Read the 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.
- Being tested
- Activity-oriented Proprioceptive Antiedema Therapy (TAPA), Complete Decongestive Therapy (CDT)
- Keywords
- Breast Cancer, Breast Cancer Lymphedema, Post-Mastectomy Secondary Lymphedema, Occupational Therapy, Proprioceptive Neuromuscular Facilitation, Neural Mobilization
- Medical subject headings
- Breast Cancer Lymphedema, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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). Receives: Other: Complete Decongestive Therapy (CDT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Baseline and 5 weeks
Secondary outcomes (2)
Quick Disabilities of the Arm, Shoulder and Hand (Quick DASH)
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.
Measured: Baseline and 5 weeks
Upper Limb Lymphedema 27 (ULL-27)
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).
Measured: Baseline and 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2018
- Study start1 Mar 2019
- Primary completion1 Sep 2021
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer LymphedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Reina Sofia de Cordoba
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Antonio José Jiménez Vílchez, Hospital Universitario Reina Sofia de Cordoba
- Investigators
- María N Muñoz Alcaraz, Principal investigator, Distrito Sanitario Córdoba Guadalquivir. Servicio Andaluz de Salud.María V Olmo Carmona, Principal investigator, UGC de Medicina Física y Rehabilitación IN. Hospital Universitario Reina SofíaAntonio J Jiménez Vílchez, Principal investigator, UGC de Medicina Física y Rehabilitación IN. Hospital Universitario Reina SofíaLuis A Pérula de Torres, Principal investigator, Unidad Docente de Medicina Familiar y Comunitaria de CórdobaJesús Serrano Merino, Principal investigator, Distrito Sanitario Córdoba Guadalquivir. Servicio Andaluz de Salud.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03762044
- Sponsor's protocol ID
- Lymphedema Rehabilitation
- Status last verified
- Sep 2023
- First submitted
- 23 Nov 2018
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We are still developing the documents, we haven't decided yet if we are going to share them
Publications
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.
PubMed 33167921
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Therapeutic Approach in Upper Limb Lymphedema Secondary to Breast Cancer: Activity-oriented Proprioceptive Antiedema Therapy (TAPA). A Randomized Controlled Therapy
- ClinicalTrials.gov ID
- NCT03762044
- Acronym / sponsor ID
- Lymphedema Rehabilitation
- Keywords
- Breast Cancer, Breast Cancer Lymphedema, Post-Mastectomy Secondary Lymphedema, Occupational Therapy, Proprioceptive Neuromuscular Facilitation, Neural Mobilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Hospital Universitario Reina Sofia de CordobaOther government
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 3 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Activity-oriented Proprioceptive Antiedema Therapy (TAPA) | Experimental | Other: 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) |
| Complete Decongestive Therapy (CDT) | Active comparator | Other: Complete Decongestive Therapy (CDT)10 sessions of 30 minutes, twice a week in a total 5 week period of complete decongestive therapy (CDT). |
Who may qualify
- Ages
- 14 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Upper limb lymphedema secondary to breast cancer grade I and II, according to the Working Group of the XI International Lymphology Congress
Key exclusion criteria (1 listed)
- Upper limb lymphedema secondary to breast cancer grade 0 and III, according to the Working Group of the XI International Lymphology Congress
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Activity-oriented Proprioceptive Antiedema Therapy (TAPA) |
| 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. | Other | Complete Decongestive Therapy (CDT) |
Primary outcome
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.
2 secondary outcomes
Quick Disabilities of the Arm, Shoulder and Hand (Quick DASH)
Time frame: Baseline and 5 weeks
Upper Limb Lymphedema 27 (ULL-27)
Time frame: Baseline and 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- Derived from this study: PubMed 33167921Munoz-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.
- Individual participant dataSharing planned: Undecided. We are still developing the documents, we haven't decided yet if we are going to share them
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
María N Muñoz Alcaraz principal investigator
Distrito Sanitario Córdoba Guadalquivir. Servicio Andaluz de Salud.
María V Olmo Carmona principal investigator
UGC de Medicina Física y Rehabilitación IN. Hospital Universitario Reina Sofía
Antonio J Jiménez Vílchez principal investigator
UGC de Medicina Física y Rehabilitación IN. Hospital Universitario Reina Sofía
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Activity-oriented Proprioceptive Antiedema Therapy (TAPA) and Complete Decongestive Therapy (CDT) in people with Breast Cancer Lymphedema and Post-Mastectomy Secondary Lymphedema, run by Hospital Universitario Reina Sofia de Cordoba at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volume (time frame: Baseline and 5 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03762044, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2023.