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Starting soon Not applicable

Combined Program of Supervised Physical Exercise and Nutritional Counseling in Ovarian Cancer Patients on Frontline Maintenance Treatment With PARP Inhibitors

NCT06139783 · tracked via the Priya Life Science Spain tracker
Sponsor
Oncare Madrid
Phase
Not applicable
Started
2028-05
Last updated
2026-10-08

Condition(s) studied

Ovarian Cancer

Investigational drug(s) / intervention(s)

Exercise and dietary recommendations

Exercise and dietary recommendations: Online physical exercise program and online nutritional assessment with personalized health and dietary recommendations

Study summary

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).

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Women ≥ 18 years old. 2. High grade serous or endometrioid ovarian, primary peritoneal or fallopian tube cancer. 3. Provide written informed consent. 4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1. 5. Stage III-IV according to International Federation of Gynecology and Obstetrics (FIGO) staging system. 6. Life expectancy of ≥ 6 months. 7. Maintenance treatment with PARPi after response to first-line platinum-based chemotherapy, initiated at least 4 weeks prior to the informed consent signature. 8. Patient is clinically stable and anticipate remaining on therapy for the duration of the exercise program. 9. Patient is willing to provide a tumor tissue sample either collected from a prior biopsy or cytoreductive/debulking surgery occurring at any time since diagnosis, if available. 10. Patients with sufficient digital capacity at the investigator's discretion. 11. Ability and willingness to comply with the study protocol for the duration of the study and with follow-up procedures. 12. Have adequate baseline function within 28 days of enrollment: * Platelets ≥ 100 × 109/L * Absolute neutrophil count (ANC) ≥ 1500/mm3 * Hemoglobin ≥ 9 g/dL or 5.6 mmol/L * Aspartate transaminase and alanine transaminase ≤2.5 × upper limit of normal (ULN), \<5 × ULN in patients with known liver metastases * Serum total bilirubin ≤ 1.5 × ULN * 1.5-3.0 × ULN may be included with appropriate starting dose adjustment to 200 mg niraparib daily. * Creatinine \<1.5 × ULN or estimated glomerular filtration rate (GFR) ≥50 ml/min by Cockcroft-Gault. Exclusion Criteria: 1. Women with diagnosis of recurrent ovarian cancer. 2. Serous, non-healing wound, ulcer or bone fracture. 3. Active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder or coagulopathy. 4. Central nervous system disease. 5. History of significant cardiovascular disease within 6 months prior to enrollment: * History of NCI CTCAE v5.0 Grade ≥ 3 symptomatic congestive heart failure (CHF) or New York Heart Association (NYHA) Class ≥ II. * High-risk uncontrolled arrhythmias (i.e., atrial tachycardia with a heart rate ≥100/min at rest, significant ventricular arrhythmia \[ventricular tachycardia\], or higher-grade atrioventricular \[AV\]-block, such as second-degree AV-block Type 2 \[Mobitz II\] or third-degree AV-block). * Myocardial infarction or ischemic disease, * Clinically significant valvular heart disease. * Ischemic or hemorrhagic stroke, * Thromboembolic events, * Peripheral vascular disease, * Aortic aneurysm, aortic dissection. 6. Pre-existing uncontrolled hypertension as documented by two baseline blood pressure readings taken at least five minutes apart, defined as systolic BP ≥ 140 or diastolic BP ≥ 90 mm Hg pressure. 7. Patient requires recurrent (≥ 1 per month) fluid drainage (eg, paracentesis, thoracocentesis, pericardiocentesis) or patient requires fluid drainage of ≥ 500 mL within 4 weeks of the expected date of exercise initiation. 8. Active infection and/or fever ≥ 38,5ºC within 7 days prior to initiation of the program requiring systemic antibiotics (excluding uncomplicated urinary tract infection). 9. Patient has undergone any major surgical procedure within 3 weeks prior to screening or is planned during the program. 10. Known QT interval corrected by the Fridericia Correction Formula values of \>470msec; patient who is known to have congenital prolonged QT syndromes; or patient who is on medication known to cause prolonged QT interval on ECG. 11. Patient had received a transfusion (platelets or red blood cells) or colony-stimulating factors (e.g., granulocyte macrophage colony-stimulating factor or recombinant erythropoietin) within 4 weeks before the exercise initiation. 12. Patient has underlying chronic lung disease, chronic obstructive pulmonary disease, metastatic lung disease, pleural effusions or pneumonitis. 13. Extensive non-oncological bone disease or presence of long-bones metastases or other symptomatic bone metastatic disease. 14. Significant peripheral sensory or motor neuropathy that could interfere with exercise program at investigator discretion. 15. Patient who are pregnant, breastfeeding, or expecting to conceive children during program.

Primary outcome measure(s)

  • To evaluate the feasibility (adherence) of a supervised physical exercise program in ovarian cancer patients on PARPi treatment. — 12 weeks
    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.

Trial sites (4)

FacilityCityRegionStatus
Hospital Clínico San Carlos Madrid Madrid
Hospital Universitario 12 de Octubre Madrid Madrid
Hospital Universitario HM Sanchinarro Madrid Madrid
Hospital Universitario Ramon y Cajal Madrid Madrid
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06139783 on ClinicalTrials.gov ↗ ← All trials in Spain