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

NCT06139783 | Not Yet Recruiting

• 1 other identifier: ACTIVA
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 4

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 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).

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (25)

• To evaluate the safety of a supervised physical exercise program in ovarian cancer patients on PARPi treatment.

  12 weeks

• 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)).

  12 weeks

• 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).

  12 weeks

• 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).

  12 weeks

• To assess quality of life at the end of intervention compared to levels prior to the start of the physical exercise program (PRO-CTCAE questionnaires).

  12 weeks

Other Outcomes (2)

• To study and characterize different cell populations to evaluate the potential effect of physical exercise on immunosurveillance.

  12 weeks

• To study and characterize different proteins to evaluate the potential effect of physical exercise on immunosurveillance.

  12 weeks

Study Arms (1)

Physycal Exercise

EXPERIMENTAL

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 WHO recommendations for cancer survivors).

Procedure: Exercise and dietary recommendations

Interventions

Exercise and dietary recommendations PROCEDURE

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

Physycal Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oncare Madrid: lead
• Apices Soluciones S.L.: collaborator

Study Sites (4)

Hospital Clínico San Carlos

Madrid, Madrid, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, Madrid, Spain

Location

Hospital Universitario HM Sanchinarro

Madrid, Madrid, Spain

Location

Hospital Universitario Ramon y Cajal

Madrid, Madrid, Spain

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Exercise

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Alfonso Cortés, MD

  Hospital Universitario Ramón y Cajal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alfonso Cortes

CONTACT

+34 912878564; info@oncaremadrid.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2023
• First Posted: November 18, 2023
• Study Start: May 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: June 25, 2025

Record last verified: 2025-06

Locations

ES (4)