NCT06139783

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Oncare Madrid · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

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 be obtained. The activity bracelet, blood pressure monitor, elastic bands set, and a document of exercise compliance will also be provided to the patient. If necessary, a local gym registration will be provided. The program will include 12 stages. Each stage will correspond to one week, with 3 to 5 sessions per week containing cardiorespiratory, strength and flexibility training tasks. Where necessary, joint mobility and neuromotor work will be included. The exercise prescription parameters will be adapted to the patient's clinical history (intensity, frequency, duration, training system, progression) and patient's interest if the clinical condition allows it. Throughout the program, periodic records of symptoms, effort and intensity scales, blood pressure, heart rate, as well as the patient's emotional state will be requested. After the registration process, a tutor (physiotherapist) will be assigned to the patient. An initial assessment is scheduled to analyze the clinical situation and to design the program. During this first consultation, the patient will be introduced to the platform and will take a preliminary course on basic training for control and monitoring of the program. During the course, questions can be asked to the tutor via the platform chat. Once the patient reports the completion of a stage, the subsequent content will be released. The tutor will supervise and follow up through scheduled video calls (one every 15 days of training); as well as through the message system. All patients will have a period of 12 weeks to complete their program. The tutor will maintain constant communication with the responsible physician. Participants will also receive an initial and mid-program online nutritional assessment with personalized health and dietary recommendations. A final nurse visit will be made at the end of the program and after 3 months of follow up to evaluate whether the patient maintains the healthy habits acquired during the 12 weeks of the program.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
PROCEDURE	Exercise and dietary recommendations	Online physical exercise program and online nutritional assessment with personalized health and dietary recommendations

Timeline

• Start date: 2026-05-01
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2023-11-18
• Last updated: 2025-06-25

Locations

4 sites across 1 country: Spain