Status:
NOT_YET_RECRUITING
Combined Program of Supervised Physical Exercise and Nutritional Counseling in Ovarian Cancer Patients on Frontline Maintenance Treatment With PARP Inhibitors
Lead Sponsor:
Oncare Madrid
Collaborating Sponsors:
Apices Soluciones S.L.
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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 a...
Detailed Description
In an initial nursing visit, patient's demographic data, epidemiological, clinical, biological and training-related variables, as well as fatigue, quality of life and mental health questionnaires will...
Eligibility Criteria
Inclusion
- 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.
- Stage III-IV according to International Federation of Gynecology and Obstetrics (FIGO) staging system.
- Life expectancy of ≥ 6 months.
- Maintenance treatment with PARPi after response to first-line platinum-based chemotherapy, initiated at least 4 weeks prior to the informed consent signature.
- Patient is clinically stable and anticipate remaining on therapy for the duration of the exercise program.
- 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.
- Patients with sufficient digital capacity at the investigator's discretion.
- Ability and willingness to comply with the study protocol for the duration of the study and with follow-up procedures.
- 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
- 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
- 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.
- 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.
- 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.
- 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.
- Active infection and/or fever ≥ 38,5ºC within 7 days prior to initiation of the program requiring systemic antibiotics (excluding uncomplicated urinary tract infection).
- Patient has undergone any major surgical procedure within 3 weeks prior to screening or is planned during the program.
- 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.
- 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.
- Patient has underlying chronic lung disease, chronic obstructive pulmonary disease, metastatic lung disease, pleural effusions or pneumonitis.
- Extensive non-oncological bone disease or presence of long-bones metastases or other symptomatic bone metastatic disease.
- Significant peripheral sensory or motor neuropathy that could interfere with exercise program at investigator discretion.
- Patient who are pregnant, breastfeeding, or expecting to conceive children during program.
Key Trial Info
Start Date :
May 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT06139783
Start Date
May 1 2026
End Date
January 1 2027
Last Update
June 25 2025
Active Locations (4)
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1
Hospital Clínico San Carlos
Madrid, Madrid, Spain
2
Hospital Universitario 12 de Octubre
Madrid, Madrid, Spain
3
Hospital Universitario HM Sanchinarro
Madrid, Madrid, Spain
4
Hospital Universitario Ramon y Cajal
Madrid, Madrid, Spain