The aim of this study is to determine if therapeutic exercise before anticancer treatment will mitigate the onset or extent of cardiotoxicity comparing to therapeutic exercise performed during anticancer treatment.
The positive relationship between physical exercise and cancer is widely justified in the literature, but an emerging research line warns of its capacity to improve the effectiveness and reduce the toxicity of cancer treatment (responsible for the appearance of side effects and comorbidities), that overload the health care system. To date, there is a lack of knowledge in different subjects: the possibility of implementing individualized exercise programs in clinical environment to mitigate the side effects of cancer treatment; the best moment in natural history of the disease to perform therapeutic exercise; and a tailored dose of exercise that maximizes its benefits. In this context, the present study will evaluate the effects of a therapeutic exercise program conducted previously at the beginning of the cancer treatment, in the treatments' toxicity against the same program conducted during cancer treatments in women with breast cancer, and its positive effects on both clinical and biological variables and their possible impact on disease-free survival. This study will be conducted in 3 phases with 110 participants in total: phase 1: a pilot study be carried out to check the feasibility of the proposed physical exercise program; phase 2: to test the effectiveness of the program ATOPE performed prior to surgical medical treatment against the same made during treatment, with a randomized controlled clinical trial; and phase 3: in which it will be integrated into the health service and a larger project will be requested at the international level.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
University of Granada
Granada, Spain
Left ventricular ejection fraction
To assess cardiac toxicity by echocardiography
Time frame: Participants will be followed over 12 months
Cardiovascular events
Number of cardiovascular events registered in a diary
Time frame: Participants will be followed over 12 months
Resting heart rate
To assess cardiac function by a Holter
Time frame: Participants will be followed over 12 months
Heart Rate variability
To assess cardiac autonomic system balance by a Holter
Time frame: Participants will be followed over 12 months
Muscle loss
To assess muscle mass loss by Inbody
Time frame: Participants will be followed over 12 months
Quality of life with the Quality of Life Questionnaire (QLQ)-C30
With the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) version 3.0. It is used to asses quality of life. It contains 30 items with both multi-item scales and single-item measures. Values are assigned between 1 and 4 (1: not at all, 2: a little, 3: enough, 4: a lot) according to the patient's responses to the item, only in items 29 and 30 evaluate with a score of 1 to 7 (1: lousy, 7: excellent). The scores obtained are standardized and a score between 0 and 100 is obtained, which determines the level of cancer impact on the patient of each of the scales. The high values in the scales of global health and function state indicate a better CV, while in the scale of symptoms it would indicate a decrease in CV since it indicates the presence of symptoms associated with cancer.
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Time frame: Participants will be followed over 12 months
Quality of life with the Quality of life Questionnaire (QLQ- BR23) a specific module.
European Organization for Research and Treatment of Cancer Breast Cancer-Specific Quality of Life Questionnaire (EORTC QLQ-BR23). It is a breast cancer module of EORTC QLQ-C30. This module contains 23 items assessing symptoms and side effects related to different treatment modalities, body image, sexuality, and future perspective. After the scoring procedures for the QLQ-C30, all scale and single-item scores are linearly transformed to a 0 to 100 scale. For the functional scales and single items (ie, body image, sexuality, and future perspective), higher scores represent a better level of functioning. For the symptom scales and single item, a higher score represents a higher level of symptoms.
Time frame: Participants will be followed over 12 months but will not be assessed in baseline
Chemotherapy regimen
type of chemotherapy agent used and number of sessions.
Time frame: Participants will be followed over 12 months
Chemotherapy doses modifications
delay of doses or reduction, total doses received from the total expected.
Time frame: Participants will be followed over 12 months
Early session termination.
Patient stopped receiving chemotherapy before last \>=1 sessions.
Time frame: Participants will be followed over 12 months
Missing bouts due to adverse effects of chemotherapy
Adverse effects of chemotherapy treatment and if it was interrupted (\>=3 missing consecutive bouts of exercise)
Time frame: Participants will be followed over 12 months
Number of hospitalizations.
Time frame: Participants will be followed over 12 months
Therapeutic exercise bout modification
\>=1 bout that required a dose modification during the program and number of bouts modified in total.
Time frame: Participants will be followed over 12 months
Time to treatment failure
days from the start to the end of chemotherapy, if it was terminated for toxicity and/or tumor progression.
Time frame: Participants will be followed over 12 months
Program adverse effects reported by the participants.
Frequency of serious and non-serious events occurring during program.
Time frame: Participants will be followed over 12 months
Functional capacity
assessed by the 6-Minute Walking Test
Time frame: Participants will be followed over 12 months
Handgrip strength
assessed by a digital dynamometer: TKK 5101 Grip-D; Takey, Tokyo, Japan
Time frame: Participants will be followed over 12 months
Shoulder strength
assessed by an isokinetic test with an isokinetic dynamometer (HUMAC NORM)
Time frame: Participants will be followed over 12 months
Lower limb strength
assessed by an isokinetic test with an isokinetic dynamometer (HUMAC NORM)
Time frame: Participants will be followed over 12 months
Abdominal strength
assessed by an isokinetic test with an isokinetic dynamometer (HUMAC NORM)
Time frame: Participants will be followed over 12 months
Flexibility
assessed by the Modified sit-and-reach test
Time frame: Participants will be followed over 12 months
Waist and hip circumferences
assessed by an inelastic tape
Time frame: Participants will be followed over 12 months
Body composition
assessed by the InBody
Time frame: Participants will be followed over 12 months
Oxidative stress
Thiobarbituric acid reactive substances (TBARS)
Time frame: Participants will be followed over 12 months
Oxidative stress
carbonyls and 8-hydroxy-2' -deoxyguanosine (8-OHdG)
Time frame: Participants will be followed over 12 months
Inmune function
Number of lymphocytes: (cluster of differentiation (CD) 8 and 4 and regulatory T lymphocytes)
Time frame: Participants will be followed over 12 months
inflammation
C-reactive protein (CRP)
Time frame: Participants will be followed over 12 months
inflammation
interleukin (IL) 6 and 10
Time frame: Participants will be followed over 12 months
inflammation
tumor necrosis factor (TNF) alpha
Time frame: Participants will be followed over 12 months
inflammation
insulin-like growth factor 1 (IGF-1)
Time frame: Participants will be followed over 12 months