Ignite Creation Date:
2024-10-25 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06518200
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-11
Brief Title:
Preventing Breast Cancer Therapy-related Cardiovascular Toxicity With a Daily-adapted Program With Mhealth Support
Sponsor:
None
Organization:
None
Study Overview
Official Title:
ATOPE-PRO Effects on the Prevention of Breast Cancer Therapy-related Cardiovascular Toxicity of a Daily-adapted and Individualized Program With Support From a Mobile Application
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ATOPE-PRO
Brief Summary:
ATOPE-PRO was developed with the intention of consolidating the integration of an innovative system for the prevention of cancer therapy-related cardiovascular toxicity CTR-CVT in the continuum care of women with breast cancer in health services It is a step further towards personalized medicine by optimizing the already available tools and integrating artificial intelligence Breast cancer survival increases every year a situation that poses new challenges for health professionals The European Society for Medical Oncology a reference in Europe has just highlighted the need to anticipate to and prevent sequelae derived from the disease and its treatments This in addition to having a positive impact on improving the quality of life of people suffering from this disease would mean a reduction in the risk of recurrence the appearance of other tumors and other diseases and death from cancer or other causes which have a personal impact and represent an overload of the healthcare system To this end ATOPE- PRO aims to optimize and refine tools already developed in the previous project ATOPE Pl1801840 integrating artificial intelligence to help identify CTR-CVT risk profiles and effective and safe doses at a clinical level early on implementing the program in a longer term and transferring the results to the social sector social level The project has 4 stages Phase 0 or start-up to make improvements and analyse usability Phase 1 for piloting and optimization Phase 2 to verify efficacy randomized controlled clinical trial and Phase 3 in which a deep analysis will be performed and future projects will be conceived
Detailed Description:
More and more women are experiencing breast cancer at younger ages yet survival rates have become very promising However years after cancer treatment related sequelae physical psychological or emotional may emerge responsible for post-disease fatalities in many women The occurrence of these sequelae largely depends on treatment-induced toxicity and individual health status which is related to lifestyle habits Among these sequelae cancer-related cardiovascular toxicity CTR-CVT is noteworthy with an incidence close to 40 in breast cancer closely linked to treatments such as chemotherapy especially anthracyclines targeted therapy trastuzumab and radiotherapy left side or mediastinum causing DNA and mitochondrial damage Traditionally defined as a reduction in left ventricular ejection fraction LVEF 50 in its mildest form and a decrease in global longitudinal strain GLS of 15 from baseline andor an increase in cardiac markers cardiac troponin I or T cTnIcTnT 99th percentile brain natriuretic peptide BNP 35 pgmL or NT-proBNP 125 pgmL to severe requiring inotropic support mechanical circulatory support or consideration for transplantation adding the need for monitoring through various tests not just LVEF as it would be too late to detect it The risk detection of TCVRC is based on medical treatments which sometimes are insufficient since many patients theoretically considered low-risk develop TCVRC This has led to the need to study and include other patient-related factors at the time of diagnosis such as previous presence of cardiovascular diseases age lifestyle habits and comorbidities to be considered for overall cardiovascular and oncological prognosis and individualized surveillance of TCVRC along with additional factors that add to the complexity of risk assessment such as cancer type duration and doses of oncological treatment However the scientific evidence supporting the inclusion of some of these parameters is of questionable quality level C and moreover they are not usually included in routine assessments making them less applicable
To improve the situation and achieve proper prevention of TCVRC it is necessary to identify parameters with good sensitivity for early detection that can preferably be performed routinely by different healthcare professionals involved in the continuum of care as well as related risk factors With this information the implementation of interventions that could limit treatment interruptions and improve survival after breast cancer would be facilitated In this context the European Society of Cardiology Guidelines highlight in addition to the improvement of detection tools the inclusion of new parameters the creation of large data registries the use of artificial intelligence or the determination of new risk stratification algorithms among others
There is a lack of access to structured physical exercise programs for cancer patients even though adaptation of exercise to their health status is crucial as excessive doses could be harmful Ondulatory exercise prescription may be more suitable for cancer patients as it allows better adaptation to their health status So far one of the systems to achieve this has been prescription based on heart rate variability HRV previously used in the sports world and in some cardiovascular pathologies but promising and little studied in the cancer world However given the complexity of this disease its treatments and the impact it has on different spheres of these patients health the inclusion of additional markers is suggested to further optimize personalized exercise programs based on individual needs With the support of current technologies monitoring and control of physiological parameters are facilitated potentially reducing the costs of in-person supervision by healthcare professionals but also the potential health risks in these patients when engaging in physical exercise
Regarding these interventions both physical activity and exercise have been recognized as potent multi-effect non-pharmacological therapies in the treatment of TCVRC although to achieve optimal physiological adaptations and individualization physical exercise programs must be correctly prescribed In recent years interest has shifted towards supervised high-intensity interval exercise which has been shown to be safe well-tolerated effective for TCVRC treatment and cost-effective However most physical exercise programs implemented are general programs with linear prescriptions and questionable adherence To address adherence issues physical exercise programs have been combined with behavioral change programs showing promising short-term results but with loss in the mediumlong term In this regard the use of technology and patient monitoring which provide continuous feedback and have proven to be an effective and useful tool for establishing a healthy lifestyle could offer a solution for both patients and professionals in improving adherence
ATOPE-PRO aims to integrate into the usual care continuum of women with breast cancer a personalized and individualized mhealth model ATOPE 20 for TCVRC prevention which will allow us to advance towards precision clinical care to complete its implementation and transfer of results resulting in an improvement in quality of life recurrence and death meeting the standards requested through refining and automating the process ensuring adherence and offering safe and effective doses of physical exercise
To improve the situation and achieve proper prevention of TCVRC it is necessary to identify parameters with good sensitivity for early detection that can preferably be performed routinely by different healthcare professionals involved in the continuum of care as well as related risk factors With this information the implementation of interventions that could limit treatment interruptions and improve survival after breast cancer would be facilitated In this context the European Society of Cardiology Guidelines highlight in addition to the improvement of detection tools the inclusion of new parameters the creation of large data registries the use of artificial intelligence or the determination of new risk stratification algorithms among others
There is a lack of access to structured physical exercise programs for cancer patients even though adaptation of exercise to their health status is crucial as excessive doses could be harmful Ondulatory exercise prescription may be more suitable for cancer patients as it allows better adaptation to their health status So far one of the systems to achieve this has been prescription based on heart rate variability HRV previously used in the sports world and in some cardiovascular pathologies but promising and little studied in the cancer world However given the complexity of this disease its treatments and the impact it has on different spheres of these patients health the inclusion of additional markers is suggested to further optimize personalized exercise programs based on individual needs With the support of current technologies monitoring and control of physiological parameters are facilitated potentially reducing the costs of in-person supervision by healthcare professionals but also the potential health risks in these patients when engaging in physical exercise
Regarding these interventions both physical activity and exercise have been recognized as potent multi-effect non-pharmacological therapies in the treatment of TCVRC although to achieve optimal physiological adaptations and individualization physical exercise programs must be correctly prescribed In recent years interest has shifted towards supervised high-intensity interval exercise which has been shown to be safe well-tolerated effective for TCVRC treatment and cost-effective However most physical exercise programs implemented are general programs with linear prescriptions and questionable adherence To address adherence issues physical exercise programs have been combined with behavioral change programs showing promising short-term results but with loss in the mediumlong term In this regard the use of technology and patient monitoring which provide continuous feedback and have proven to be an effective and useful tool for establishing a healthy lifestyle could offer a solution for both patients and professionals in improving adherence
ATOPE-PRO aims to integrate into the usual care continuum of women with breast cancer a personalized and individualized mhealth model ATOPE 20 for TCVRC prevention which will allow us to advance towards precision clinical care to complete its implementation and transfer of results resulting in an improvement in quality of life recurrence and death meeting the standards requested through refining and automating the process ensuring adherence and offering safe and effective doses of physical exercise
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None