Colorectal Cancer
Conditions
Interventions
One hundred patients (men and women) from the Sorocaba Hospital Complex with a recent clinical diagnosis of metastatic colorectal cancer and candidates for neoadjuvant chemotherapy will be selected. T
G11.427.410.698.277
Sponsors
Escola de Educação Física e Esporte da Universidade de São Paulo
Conjunto Hospitalar de Sorocaba
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients aged 18 years or older; recent diagnosis of stage IV colorectal cancer, with measurable lesion and available and proven biopsy; candidates for chemotherapy sessions; Performance Status Scale (Eastern Cooperative Oncology Group - ECOG) between 0 and 2
Exclusion criteria
Exclusion criteria: Presence of unstable (uncontrolled) comorbidity; presence of dementia (score <23 on the Mini Mental State Examination); having participated in a physical training program in the last 6 months; having active infections
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is Response to Treatment, which will be assessed using the Response Evaluation in solid tumors (RECIST) questionnaire. It is expected that individuals undergoing the combined physical training protocol will show a better response to treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following parameters will be evaluated: cardiorespiratory fitness through the ergospirometry test; muscle strength using the one repetition maximum test (1-RM) for lower limbs and handgrip strength using the handgrip dynamometry method; functionality through sit and stand and Timed Up and Go tests; level of physical activity using accelerometry and the International Physical Activity Questionnaire; body composition using dual-energy X-ray absorptiometry (DEXA); quality of life using the FACT-G questionnaire; immune system through blood count and mononucleated cell methods; symptoms using the MD Anderson Cancer Center Symptom Assessment Scale; miRNAs through blood collection. After the tests, the 12-week combined physical training protocol will begin. Blood samples for miRNA analysis will be collected at 5 moments: 1st) before the first session of combined physical training (control measure - as physical exercise stimulates the production of extracellular vesicles with miRNAs, this production must be very small before the session training); 2nd) immediately after the first combined physical training session (training effect - to verify whether the physical exercise was capable of producing extracellular vesicles with miRNAs); 3rd) before the last combined physical training session (control measure); 4th) immediately after the last combined physical training session (training effect); 5th) seven days after 12 weeks of combined physical training (check if there is still production of extracellular vesicles with miRNAs, even without the effect of the last training session, as the body returns to homeostasis on average 48 hours after the last training session ). At the end of the physical training period, pre-intervention assessments will be repeated, with the addition of treatment toxicity assessment, which will be measured using the Common Terminology Criteria for Adverse Events (CTC-AE) questionnaire. | — |
Countries
Brazil
Contacts
Public ContactTelma Moraes
Universidade de São Paulo
Outcome results
None listed