Trial Title:
Preventing Breast Cancer Therapy-related Cardiovascular Toxicity With a Daily-adapted Program With Mhealth Support
NCT ID:
NCT06518200
Condition:
Breast Cancer Female
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Breast Neoplasms
Cancer therapy-related cardiovascular toxicity
Physical Exercise
Prevention
Quality of life
Rehabilitation
Telemedicine
Health related lifestyle
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Randomized controlled trial
Primary purpose:
Prevention
Masking:
Double (Investigator, Outcomes Assessor)
Masking description:
Double masking until end of intervention and evaluations
Intervention:
Intervention type:
Behavioral
Intervention name:
Individualised health recommentations
Description:
Individualised recommendations for physical activity and exercise, lifestyle, stress
management and symptom management with solid scientific evidence established by health
organisations and scientific reference committeess through the ATOPE-PRO mobile
application based on patients reported status.
Arm group label:
Intervention Group
Intervention type:
Behavioral
Intervention name:
General health recommendations
Description:
Recommendations for physical activity and exercise, lifestyle, stress management and
symptom management with solid scientific evidence established by health organisations and
scientific reference committeess through the ATOPE-PRO mobile application.
Arm group label:
Control Group
Intervention type:
Behavioral
Intervention name:
Individualised physical exercise program
Description:
Follow-up of an individualised exercise program adjusted by daily monitoring of the level
of physical, physiological and psychological condition.
Arm group label:
Intervention Group
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, Pl18/01840),
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 and/or an increase in cardiac markers (cardiac troponin I or T cTnI/cTnT >99th
percentile, brain natriuretic peptide BNP ≥35 pg/mL, or NT-proBNP ≥125 pg/mL) 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 medium/long 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+ 2.0) 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Recently diagnosed with stage I-III breast cancer
- Treatments predisposing to cardiotoxicity (anthracyclines, targeted therapies,
radiotherapy)
- Signed informed consent form
- Medical authorisation to participate
- Smartphone user level
Exclusion Criteria:
- Patient underwent previous cancer treatments.
- Patients were previously diagnosed with cancer
- Pregnant patients. Patients performing other type of therapeutic exercise at
diagnosis time with an intake >or = to 150 moderate-intensity or 75 min of
vigorous-intensity a day
- Therapeutic exercise practice not recommended because psychiatric or cognitive
disorders or cute or chronic condition that prevents exercise (advanced lung
disease, oxygen requirement, stenosis >70%, metastasis etc.).
Gender:
Female
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Granada
Address:
City:
Granada
Zip:
18016
Country:
Spain
Start date:
January 1, 2025
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Universidad de Granada
Agency class:
Other
Collaborator:
Agency:
Instituto de Salud Carlos III
Agency class:
Other
Collaborator:
Agency:
Hospital Clinico Universitario San Cecilio
Agency class:
Other
Source:
Universidad de Granada
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06518200
https://ieeexplore.ieee.org/document/9314150
