Hospital Clínico Universitario de Santiago
Santiago de Compostela, A Coruña, 15706, Spain
NCT Number: NCT03964142
This project aims to determine whether a comprehensive cardiac rehabilitation program including supervised exercise training is able to prevent cardiotoxicity during treatment with anthracyclines and / or anti-HER-2 antibodies in women with breast cancer. Participants will be randomly allocated to cardiac rehabilitation (intervention group) or conventional management with physical exercise recommendation (control group).
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Notify Me18 year–69 year
Female
Interventional
Not applicable
Santiago de Compostela, A Coruña, 15706, Spain
Cardiovascular toxicity caused by chemotherapy is the leading cause of death in patients who survive cancer. Physical exercise during chemotherapy has shown to improve quality of life and decrease the risk of death. The objective of this project is to determine whether an intervention through a comprehensive cardiac rehabilitation program including supervised physical exercise is able to prevent anthracyclines and / or anti-HER-2 antibodies-induced cardiotoxicity in women with breast cancer.
For this purpose, the investigators intend to conduct a randomized controlled study including female patients managed under the same cardiotoxicity prevention protocol (clinical, laboratory and echocardiographic follow-up assessment). Patients will be randomized to a non-pharmacological intervention (participation in a multidisciplinary cardiac rehabilitation program with supervised exercise training) or control (conventional management and physical activity recommendation)*.
The investigators hypothesize that a cardiac rehabilitation program may limit chemotherapy-induced cardiotoxicity in women with breast cancer, improve cardiac remodeling assessed by echocardiography and enhance their global cardiovascular risk profile to a greater extent, compared to control group.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Integrated cardiac rehabilitation program that includes supervised exercise training*.
Time frame: Baseline to every 3 months through study completion, at the end of the study at an average of 18 months, and every year after study completion up to a maximum of 5 years
Fall of 10 absolute percentage points of left ventricular ejection fraction with final value below 53% or global longitudinal strain fall >15% with respect to baseline
Time frame: Baseline and at the end of the study at an average of 18 months
Score achieved in the Functional Assessment of Cancer Therapy - Breast plus Arm Morbidity (FACT-B+4) questionnaire, a specific validated scale to assess quality of life of women with breast cancer. It comprises 27 items within 5 areas of assessment: physical well-being (7 items), social and family environment (7 items), emotional well-being (7 items), functional well-being (6 items) and worries related to the diagnosis and treatment of the disease (9 items). Each item is scored by means of a Likert scale from 0 to 5, with higher scores representing better results. The total score is obtained by adding the scores for each item, and ranges from a minimum of 0 (worst posible result) to a maximum of 146 (best possible result).
Time frame: Every 3 months during study completion and at the end of the study at an average of 18 months
Significant cardiovascular and non-cardiovascular adverse effects during treatment, threatening life, requiring admission, prolonging hospitalization, being clinically relevant or causing chemotherapy interruptions
Time frame: Baseline and at the end of the study at an average of 18 months
Change in functional capacity assessed by conventional ergometry, cardiopulmonary exercise test or the 6-minute walking test (6MWT) (metabolic equivalents: METs or peak oxygen consumption: VO2) * .
*Due to COVID-19 pandemic, participants' assessment with CPET had to be stopped for safety concerns. In such cases, functional capacity was estimated from the maximum work rate in the 6-minute walking test (6MWT). This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes, which is well correlated with VO2. The 6MWT has been proved to be valid and reliable for functional capacity assessment in the study population.
Time frame: Baseline and at the end of the study at an average of 18 months
Number of repetitions in the sit-to-stand test within 30 seconds
Time frame: Baseline and at the end of the study at an average of 18 months
Range of degrees in shoulder movement measured by goniometry
Time frame: Baseline and at the end of the study at an average of 18 months
Kilograms by dynamometry of right and left upper limbs
Time frame: Baseline and at the end of the study at an average of 18 months
Score achieved in the SPADI (shoulder pain and disability index) questionnaire. The pain dimension consists of five questions regarding the severity of an individual's pain, functional activities are assessed with eight questions. Each question may be scored from 0 to 10. Verbal anchors for the pain dimension are 'no pain at all' (0) and 'worst pain imaginable' (10) ,and those for the functional activities are 'no difficulty' (0) and 'so difficult it required help' (10). The scores from both dimensions are averaged to produce a total score ranging from 0 (best) to 100 (worst).
Time frame: Baseline and at the end of the study at an average of 18 months
Dyslipidemia, Diabetes mellitus, Arterial Hypertension, Smoking status
Time frame: Baseline and at the end of the study at an average of 18 months
Height measured in cm
Time frame: Baseline and at the end of the study at an average of 18 months
Weight measured in kg
Time frame: Baseline and at the end of the study at an average of 18 months
Weight and height will be combined to report BMI in kg/m^2
Time frame: Baseline and at the end of the study at an average of 18 months
Abdominal perimeter measured with a tape measure in cm
Time frame: Baseline and at the end of the study at an average of 18 months
Resting heart rate by pulse oximetry (beats per min)
Time frame: Baseline and at the end of the study at an average of 18 months
Resting blood pressure by sphyngomanometer in mmHg
Time frame: Baseline and at the end of the study at an average of 18 months
Value of NT-ProBNP(pg/mL) in blood tests
Time frame: Baseline and at the end of the study at an average of 18 months
Value of troponin I (ng/mL) in blood tests
Time frame: Baseline and at the end of the study at an average of 18 months
Value of haemoglobin (g/dL) in blood tests
Time frame: Baseline and at the end of the study at an average of 18 months
Validated questionnaire to assess adherence to Mediterranean diet, including 14 questions regarding dietary habits, rated with 0 or +1 points. Global score is calculated by summing points and ranges from 0 to 14, with higher score representing higher adherence.
Time frame: Baseline and at study completion at an average of 18 months, plus at the end of training (at an average of 12 to 15 months) in the intervention group
Score achieved in the depression subscale of the Zigmond and Snaith test for anxiety or depression, a self-applied questionnaire. Depression scale includes 7 items each, scored on Likert scale from 0 to 3. Global score ranges from 0 to 21, with higher scores representing greater depression. The authors suggest that scores higher than eleven would indicate "case" and more than eight would be considered "probable case" (Zigmond and Snaith, 1983).
Time frame: Baseline and at study completion, plus at the end of training (at an average of 12 to 15 months) in the intervention group
Score achieved in the anxiety subscale of the Zigmond and Snaith test for anxiety or depression, a self-applied questionnaire. Anxiety scale includes 7 items each, scored on Likert scale from 0 to 3. Global score ranges from 0 to 21, with higher scores representing greater anxiety. The authors suggest that scores higher than eleven would indicate "case" and more than eight would be considered "probable case" (Zigmond and Snaith, 1983).
Time frame: Baseline and at study completion at an average of 18 months
Minutes of In- and out-of-hospital dedicated physical activity
Time frame: Baseline and at study completion at an average of 18 months
Score achieved in the Godin Leisure Test Exercise Questionnaire (GLTEQ) for quantification of physical activity. Activities are classified into three subgroups: "strenuous," "moderate," and "light." The scores corresponding to the energy expenditure (metabolic equivalent (MET)) are obtained by multiplying activities performed for more than 15 min in a week with their coefficients. The numbers represent the MET intensity values (strenuous/ exhausting exercises: 9 METs, moderate exercises: 5 METs, and light exercises: 3 METs).The increasing scores are associated with the increasing number of exercise behaviors, providing references about the contribution of physical activity to health: the activity score of 24 units and more as active (substantial benefits); the activity score of 14-23 units as moderately active (some benefits); and the activity score of 13 units and less as inactive (less substantial or low benefits).
Time frame: Baseline after surgery and 2-4 weeks after the end of chemotherapy (at an average of 12 to 15 months)
Perimeter of the upper limb by cirtometry (cm), stage and grade as defined by the Spanish Society of Rehabilitation and Physical Medicine
Time frame: At the end of the cardiac rehabilitation program at an average of 12 to 15 months
Number of training sessions attended / number of sessions planned
Time frame: At the end of the cardiac rehabilitation program at an average of 12 to 15 months
Adverse events during training
Time frame: Baseline and at the end of the cardiac rehabilitation program at an average of 12 to 15 months
Program-related expectations at baseline and at the end of the program' are collected through an open question "What do you expect to achieve by participating in the program?" Responses regarding expectations will be categorized by the evaluator within the following areas: psychological sphere and/or social sphere and/or physical sphere. Global expectations of benefit are scored from 0 (no benefit) to 10 (highest benefit).
Time frame: At the end of the cardiac rehabilitation program at an average of 12 to 15 months
Satisfaction at the end of the program is assessed by a questionnaire including 9 questions concerning comfort with training sessions, training spaces and development of the program, which are scored from 0 (worse posible result) to 10 (best posible result). Total score is calculated by adding for each question, and ranges from 0 to 90.
Hospital Clinico Universitario de Santiago
Other
Randomized Controlled Trial on Comprehensive Exercise-based Cardiac Rehabilitation Programs for the Prevention of Anthracyclines and/or Anti-HER2 Antibodies-induced Cardiotoxicity in Breast Cancer
Acronym: ONCORE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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