Colorectal cancer
Conditions
Interventions
This is a randomized, controlled, two-arm, single-blind clinical trial with parallel groups, aiming to investigate the effects of combined physical training on the modulation of the autonomic nervous
Cross-sectional Study II, composed of fifty patients
and Longitudinal Study, composed of fifty patients. In the longitudinal arm, the fifty participants will be distributed into two parallel groups: twenty-five patients allocated to the physical trainin
Sponsors
Universidade de São Paulo
Universidade de São Paulo
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients aged over 18 years old; both sexes;recent diagnosis of colorectal cancer at any stage (new cases) for Crosssectional I and II, and for the longitudinal study, patients with metastatic colorectal cancer with measurable lesions and available and verified biopsy;candidates for chemotherapy sessions (Crosssectional II and Longitudinal);undergoing the first cycle of chemotherapy (Cross-sectional II);performance Status Scale (ECOG- Eastern Cooperative Oncology Group) between 0 and 2;no dementia (score less than 23 on the Mini-Mental State Examination);not having participated in a physical training program in the last 6 months (Longitudinal);no active infections at the time of inclusion in the studies
Exclusion criteria
Exclusion criteria: Patients with uncontrolled comorbidities;patients with cognitive or mental limitations: they may have difficulty understanding and adhering to treatment, requiring additional support;patients with a history of substance abuse: substance use can complicate pain management and symptom control, as well as affect adherence to treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome aims to evaluate the modulation of the cardiac autonomic nervous system, verified by the method of measuring heart rate variability indices at rest and during an exercise stress test, using the Polar V800 Heart Rate Monitor Kempele Finland equipment for the recording of consecutive heartbeats (R-R interval), whereby the parameters obtained by linear methods divided into time-domain and frequency-domain analysis will be observed, in accordance with the guidelines of the Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. For the collection of these parameters, participants will undergo recording in the supine position for a period of five minutes in a quiet environment and a climate-controlled room, with measurements mandatory performed in the morning period aiming to minimize interferences related to circadian variations in heart rate | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcomes aim to evaluate physical fitness, physical activity level, quality of life, and symptom severity, verified respectively by the methods of ergospirometry on a cycle ergometer, triaxial accelerometry, the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30, and the M. D. Anderson Symptom Inventory, whereby the parameters of peak oxygen consumption (VO2 peak) measured in milliliters per kilogram per minute, daily step count and time in sedentary behavior, numerical scores for functional well-being, and indices of clinical symptom intensity and interference in activities of daily living will be observed | — |
Countries
BR
Contacts
Public ContactLilian Brito
Universidade de São Paulo
Outcome results
None listed