Patients will be recruited in the 4 participating sites and will sign the informed consent If they agree to participate. It is planned to include 32 patients with ovarian cancer on maintenance PARPi after response to first-line platinum-based chemotherapy in the study.
Patients included in the study will follow an online physical exercise program supervised by a physical exercise specialist in which they will perform up to 300 minutes of moderate-intensity aerobic exercise or up to 150 minutes of vigorous aerobic exercise and 2 strength sessions per week for 12 weeks (following World Health Organization (WHO) recommendations for cancer survivors).
Women ≥ 18 years old.
High grade serous or endometrioid ovarian, primary peritoneal or fallopian tube cancer.
Provide written informed consent.
Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
Women with diagnosis of recurrent ovarian cancer.
Serous, non-healing wound, ulcer or bone fracture.
Active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder or coagulopathy.
Central nervous system disease.
Single group
Exercise and dietary recommendations
Procedure/SurgeryOnline physical exercise program and online nutritional assessment with personalized health and dietary recommendations
To evaluate the feasibility (adherence) of a supervised physical exercise program in ovarian cancer patients on PARPi treatment.
Adherence to the program will be evaluated considering the total program completed/total program. Adherence per patient will be considered adequate if 70% of the planned program is exceeded. The percentage of patients who have been adherent to the program will be evaluated. Feasibility will be evaluated according to the percentage of adherent patients. The intervention will be considered feasible if the percentage of adherent patients is greater than or equal to 2/3 (66.6%) of the patients who give their consent to participate in the program and attend at least the first session.
To evaluate the safety of a supervised physical exercise program in ovarian cancer patients on PARPi treatment.
Frequency of AEs occurring during the study, globally and program related will be described. Adverse events will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
To assess fatigue levels at the end of intervention compared to levels prior to the start of the physical exercise program (Functional Assessment of Chronic Illness Therapy (FACIT-Fatigue questionnaire)).
Difference in fatigue levels at the end of intervention compared to levels prior to the start of the physical exercise and nutrition program (FACIT-Fatigue questionnaire). Score range: 0-52. Higher scores mean a better outcome.
To assess quality of life at the end of intervention compared to levels prior to the start of the physical exercise program european organization for research and treatment of cancer quality of life questionnaire core-30 (EORTC QLQ-C30).
Difference in quality of life at the end of intervention compared to levels prior to the start of the physical exercise and nutrition program (EORTC QLQ-C30). Score range: 0-100. A high score for the global health status represents a high quality of life.
To assess quality of life at the end of intervention compared to levels prior to the start of the physical exercise program european organization for research and treatment of cancer quality of life questionnaire ovarian 28 (EORTC QLQ-OV28).
Difference in quality of life at the end of intervention compared to levels prior to the start of the physical exercise and nutrition program (EORTC QLQ-OV28).
To study and characterize different cell populations to evaluate the potential effect of physical exercise on immunosurveillance.
Difference in cell populations at the end the intervention compared to levels prior to the start of the physical exercise and nutrition program
To study and characterize different proteins to evaluate the potential effect of physical exercise on immunosurveillance.
Difference in proteins at the end the intervention compared to levels prior to the start of the physical exercise and nutrition program
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Oncare Madrid
Lead sponsor
Apices Soluciones S.L.
Collaborator
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