Drug-Related Side Effects and Adverse Reactions
Conditions
Interventions
We will carry out a randomized, controlled, single-blind clinical trial to evaluate whether physical exercise, whether using mini cycle ergometers or walking, carried out between chemotherapy sessions
I03.350
Sponsors
Universidade Estadual do Centro Oeste
Hospital de Caridade São Vicente de Paulo
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Adult patients (above 18 years old) undergoing chemotherapy treatment. Patients diagnosed with solid cancer who require regular chemotherapy infusions. Adequate physical condition to perform aerobic exercise during the infusion, as assessed by a healthcare professional. Ability to understand and follow study instructions. Availability to regularly participate in chemotherapy sessions during the study period.
Exclusion criteria
Exclusion criteria: Patients with medical contraindications for engaging in physical exercise. Presence of severe medical conditions, in addition to cancer, that may interfere with participation in the study or the ability to perform exercises during the infusion. Significant physical incapacity that hinders the safe execution of exercises. History of serious cardiac problems or recent cardiac events. Participation in other research studies simultaneously. Psychological or emotional conditions that may negatively affect participation in the study or adherence to the exercise protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A minimum variation of 15% in pre- and post-intervention scores is anticipated. Additionally, qualitative reports from patients regarding their perception of their quality of life will be considered. Statistical analysis will employ appropriate tests, such as ANOVA, to identify statistically significant differences between the groups. Data collection, conducted throughout the treatment, will utilize the EORTC QLQ C30 questionnaire to measure quality of life. Parameters will include overall quality of life scores, levels of fatigue, presence of symptoms such as nausea and pain, and functional capacity. | — |
Secondary
| Measure | Time frame |
|---|---|
| Significant changes in daily physical activity-related behavior are expected based on variations of at least 20% in pre- and post-intervention scores. Statistical analysis will employ appropriate methods, such as mean comparison tests, to identify statistically significant differences in behavior changes related to this theme The primary instrument will be the International Physical Activity Questionnaire (IPAQ) short-form, focusing on parameters such as total volume of physical activity, intensity of activities performed, and time spent in sedentary behaviors;Significant changes in biochemical parameters will be determined by variations of at least 10% in pre- and post-intervention values Blood plasma samples will be collected before and after the intervention Biochemical parameters will include lipid levels, glucose, inflammatory markers, and liver enzymes. Analyses will be conducted using standard laboratory methods, such as spectrophotometry for lipids and glucose, and specific assays for inflammatory markers and liver enzymes. Statistical analysis will employ appropriate methods, such as the Student's t-test, to identify statistically significant differences in changes in biochemical parameters related to the intervention | — |
Countries
Brazil, Paraguay
Contacts
Public ContactDiego Dantas
Universidade Estadual do Centro Oeste
Outcome results
None listed