Ovarian CancerNCT06139783
Combined Program of Supervised Physical Exercise and Nutritional Counseling in Ovarian Cancer Patients on Frontline Maintenance Treatment With PARP Inhibitors
A study testing Exercise and dietary recommendations in people with Ovarian Cancer, run by Oncare Madrid at 4 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Exercise and dietary recommendations
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 4 sitesSpain
- Study dates
- May 2028to Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 19Show fewer
- 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
- 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.
Who cannot join
- 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.
Show all 23Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain4 sites
Hospital Clínico San Carlos
Madrid, Madrid
Arancha Manzano
Hospital Universitario 12 de Octubre
Madrid, Madrid
Ainhoa Madariaga
Hospital Universitario HM Sanchinarro
Madrid, Madrid
Arantzazu Barquín
Hospital Universitario Ramon y Cajal
Madrid, Madrid
Alfonso Cortés
About this study
Official title: Combined Program of Supervised Physical Exercise and Nutritional Counseling in Ovarian Cancer Patients on Frontline Maintenance Treatment With PARP Inhibitors: ACTIVA Study
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).
Read the 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
- Being tested
- Exercise and dietary recommendations
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise and dietary recommendationsProcedure or surgery
Online physical exercise program and online nutritional assessment with personalized health and dietary recommendations
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Procedure: Exercise and dietary recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (25)
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.
Measured: 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)).
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.
Measured: 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).
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.
Measured: 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).
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).
Measured: 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).
Difference in quality of life at the end of intervention compared to levels prior to the start of the physical exercise and nutrition program (PRO-CTCAE questionnaires).
Measured: 12 weeks
To compare biological data at the end of intervention compared to baseline data: baseline physical exercise level
Difference in biological data at the end of intervention compared to baseline data: physical exercise level (6 minute-walk test)
Measured: 12 weeks
To compare fitness data at the end of intervention compared to baseline data: baseline physical exercise level
Difference in fitness data at the end of intervention compared to baseline data: physical exercise level (6 minute-walk test)
Measured: 12 weeks
To compare biological data at the end of intervention compared to baseline data: baseline physical exercise level
Difference in biological data at the end of intervention compared to baseline data: physical exercise level International Physical Activity Questionnaire (IPAQ questionnaire).
Measured: 12 weeks
To compare fitness data at the end of intervention compared to baseline data: baseline physical exercise level
Difference in fitness data at the end of intervention compared to baseline data: physical exercise level International Physical Activity Questionnaire (IPAQ questionnaire).
Measured: 12 weeks
To compare biological data at the end of intervention compared to baseline data: baseline body composition
Difference in biological data at the end of intervention compared to baseline data: physical exercise level (body composition).
Measured: 12 weeks
To compare fitness data at the end of intervention compared to baseline data: baseline body composition
Difference in fitness data at the end of intervention compared to baseline data: physical exercise level (body composition).
Measured: 12 weeks
To compare biological data at the end of intervention compared to baseline data: baseline anthropometric values
Difference in biological data at the end of intervention compared to baseline data: physical exercise level (anthropometric values).
Measured: 12 weeks
To compare fitness data at the end of intervention compared to baseline data: baseline anthropometric values
Difference in fitness data at the end of intervention compared to baseline data: physical exercise level (anthropometric values).
Measured: 12 weeks
To compare biological data at the end of intervention compared to baseline data: baseline upper body strength/lower body strengt
Difference in biological data at the end of intervention compared to baseline data: physical exercise level (upper body strength (handgrip)/lower body strength (30 second sit to stand).
Measured: 12 weeks
To compare fitness data at the end of intervention compared to baseline data: baseline upper body strength/lower body strengt
Difference in fitness data at the end of intervention compared to baseline data: physical exercise level (upper body strength (handgrip)/lower body strength (30 second sit to stand).
Measured: 12 weeks
To compare psychological parameters at the end of intervention compared to baseline parameters:insomnia (ISI).
Difference in psychological parameters at the end of intervention compared to baseline parameters: Insomnia Severity Index (ISI).
Measured: 12 weeks
To compare psychological parameters at the end of intervention compared to baseline parameters: depression and anxiety (HADS).
Difference in psychological parameters at the end of intervention compared to baseline parameters: Hospital Anxiety and Depression Scale (HADS).
Measured: 12 weeks
To compare fatigue levels at 3 months follow-up after the intervention vs levels prior to the start of the physical exercise program
Difference in fatigue levels at 3 months follow-up after the intervention vs levels prior to the start of the physical exercise program.
Measured: 6 months
To compare quality of life at 3 months follow-up after the intervention vs levels prior to the start of the physical exercise program
Difference in quality of life at 3 months follow-up after the intervention vs levels prior to the start of the physical exercise program.
Measured: 6 months
To compare biological data at 3 months follow-up after the intervention vs levels prior to the start of the physical exercise program
Difference in biological data at 3 months follow-up after the intervention vs levels prior to the start of the physical exercise program.
Measured: 6 months
To compare physical exercise level at 3 months follow-up after the intervention vs levels prior to the start of the physical exercise program
Difference in physical exercise level at 3 months follow-up after the intervention vs levels prior to the start of the physical exercise program.
Measured: 6 months
To compare body composition at 3 months follow-up after the intervention vs levels prior to the start of the physical exercise program
Difference in body composition at 3 months follow-up after the intervention vs levels prior to the start of the physical exercise program.
Measured: 6 months
To compare anthropometric values at 3 months follow-up after the intervention vs levels prior to the start of the physical exercise program
Difference in anthropometric values at 3 months follow-up after the intervention vs levels prior to the start of the physical exercise program.
Measured: 6 months
To compare upper body strength (handgrip)/lower body strength parameters at 3 months follow-up after the intervention vs levels prior to the start of the physical exercise program.
Difference in upper body strength /lower body strength at 3 months follow-up after the intervention vs levels prior to the start of the physical exercise program.
Measured: 6 months
To compare psychological parameters at 3 months follow-up after the intervention vs levels prior to the start of the physical exercise program
Difference in psychological parameters at 3 months follow-up after the intervention vs levels prior to the start of the physical exercise program.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study startMay 2028 (estimated)
- Primary completionJan 2029 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oncare Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Apices Soluciones S.L.
- Responsible party
- Sponsor
- Investigators
- Alfonso Cortés, MD, Principal investigator, Hospital Universitario Ramon y Cajal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06139783
- Sponsor's protocol ID
- ACTIVA
- Status last verified
- Oct 2026
- First submitted
- 9 Nov 2023
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Program of Supervised Physical Exercise and Nutritional Counseling in Ovarian Cancer Patients on Frontline Maintenance Treatment With PARP Inhibitors: ACTIVA Study
- ClinicalTrials.gov ID
- NCT06139783
- Acronym / sponsor ID
- ACTIVA
- Conditions
- Ovarian Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Oncare MadridUniversity, hospital or other
- Collaborators
- Apices Soluciones S.L.
- Study start
- May 2028 (estimated)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physycal Exercise | Experimental | Procedure: Exercise and dietary recommendationsPatients 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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.
Key exclusion criteria (23 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise and dietary recommendationsOnline physical exercise program and online nutritional assessment with personalized health and dietary recommendations | Procedure or surgery | Physycal Exercise |
Primary outcome
To evaluate the feasibility (adherence) of a supervised physical exercise program in ovarian cancer patients on PARPi treatment.
Time frame: 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.
25 secondary outcomes
To evaluate the safety of a supervised physical exercise program in ovarian cancer patients on PARPi treatment.
Time frame: 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)).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 12 weeks
To compare biological data at the end of intervention compared to baseline data: baseline physical exercise level
Time frame: 12 weeks
To compare fitness data at the end of intervention compared to baseline data: baseline physical exercise level
Time frame: 12 weeks
To compare biological data at the end of intervention compared to baseline data: baseline physical exercise level
Time frame: 12 weeks
To compare fitness data at the end of intervention compared to baseline data: baseline physical exercise level
Time frame: 12 weeks
To compare biological data at the end of intervention compared to baseline data: baseline body composition
Time frame: 12 weeks
To compare fitness data at the end of intervention compared to baseline data: baseline body composition
Time frame: 12 weeks
To compare biological data at the end of intervention compared to baseline data: baseline anthropometric values
Time frame: 12 weeks
To compare fitness data at the end of intervention compared to baseline data: baseline anthropometric values
Time frame: 12 weeks
To compare biological data at the end of intervention compared to baseline data: baseline upper body strength/lower body strengt
Time frame: 12 weeks
To compare fitness data at the end of intervention compared to baseline data: baseline upper body strength/lower body strengt
Time frame: 12 weeks
To compare psychological parameters at the end of intervention compared to baseline parameters:insomnia (ISI).
Time frame: 12 weeks
To compare psychological parameters at the end of intervention compared to baseline parameters: depression and anxiety (HADS).
Time frame: 12 weeks
To compare fatigue levels at 3 months follow-up after the intervention vs levels prior to the start of the physical exercise program
Time frame: 6 months
To compare quality of life at 3 months follow-up after the intervention vs levels prior to the start of the physical exercise program
Time frame: 6 months
To compare biological data at 3 months follow-up after the intervention vs levels prior to the start of the physical exercise program
Time frame: 6 months
To compare physical exercise level at 3 months follow-up after the intervention vs levels prior to the start of the physical exercise program
Time frame: 6 months
To compare body composition at 3 months follow-up after the intervention vs levels prior to the start of the physical exercise program
Time frame: 6 months
To compare anthropometric values at 3 months follow-up after the intervention vs levels prior to the start of the physical exercise program
Time frame: 6 months
To compare upper body strength (handgrip)/lower body strength parameters at 3 months follow-up after the intervention vs levels prior to the start of the physical exercise program.
Time frame: 6 months
To compare psychological parameters at 3 months follow-up after the intervention vs levels prior to the start of the physical exercise program
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alfonso Cortés, MD principal investigator
Hospital Universitario Ramon y Cajal
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and dietary recommendations in people with Ovarian Cancer, run by Oncare Madrid at 4 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alfonso Cortes (+34 912878564, info@oncaremadrid.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the feasibility (adherence) of a supervised physical exercise program in ovarian cancer patients on PARPi treatment. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.