Ovarian CancerPREHONEDNCT07058753
Prehabilitation in Ovarian Cancer Patients During Chemiotherapy Before Cytoreductive Surgery.
A study testing Prehabilitation. An intensive prehabilitation for NACT patients in people with Ovarian Cancer, run by Medical University of Silesia at 1 site in Poland.
Trial summary
Prehabilitation includes care for patients preparing for surgery. This is a modern approach aimed at increasing the patient's functional capacity before surgery and improving postoperative results. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Prehabilitation. An intensive prehabilitation for NACT patients
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jul 2025to 1 Jul 2031
- 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 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with confirmed ovarian cancer
- No possibility of performing primary debulking surgery (Fagotti score > 8 points). Referral patient for neoadjuvant chemotherapy
- Consent to participate in the study
- Age over 18 years
Who cannot join
- Performing primary debulking surgery
- Lack of consent to participate in the study
- Aletti score < 4 points in interval debulking surgery
- Severe neurological/psychiatric disorders that make contact with the patient difficult
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site
Department of Gynecology, Obstetrics and Gynecological Oncology, University Clinical Center of the Medical University of Silesia
Katowice, 40-752
About this study
Official title: An Intense Course of Prehabilitation in Ovarian Cancer Patients During Neoadjuvant Treatment Awaiting for Interval Debulking Surgery. PREHONED - a Prospective, Randomized, Multicentre Clinical Study.
Prehabilitation includes care for patients preparing for surgery. This is a modern approach aimed at increasing the patient's functional capacity before surgery and improving postoperative results. Prehabilitation includes preoperative physical activity, nutritional intervention, psychological support, cessation of stimulants and optimization of laboratory test results.
Many studies have shown a positive effect of prehabilitation on postoperative results, mainly reducing the number of postoperative complications and shortening the hospitalization time.
Read more
The assumed time of prehabilitation is 2-6 weeks, but in the case of oncology patients, the procedure should not be delayed only for the sake of prehabilitation.
Our study includes oncology patients with ovarian cancer who are referred for neoadjuvant chemotherapy before interval cytoreductive surgery. The assumption of the study is an intensive course of prehabilitation during neoadjuvant treatment, which should provide significantly better postoperative results.
- Conditions
- Ovarian Cancer
- Being tested
- Prehabilitation. An intensive prehabilitation for NACT patients
- Keywords
- ovarian cancer, prehabilitation, interval debulking surgery, neoadjuvant chemotherapy
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prehabilitation. An intensive prehabilitation for NACT patientsProcedure or surgery
Patients referred to NACT (neoadjuvant chemotheraphy) for advanced ovarian cancer will undergo an intensive course of prehabilitation including physical exercise, a high-protein diet, protein and vitamin supplementation, optimization of laboratory test results, and psychological support will be provided.
| Study group | Role | What they receive |
|---|---|---|
| Intense course of prehabilitation | Experimental | Patients undergoing intense prehabilitation program Receives: Procedure: Prehabilitation. An intensive prehabilitation for NACT patients |
| Standard preoperative care | No intervention | Patients with standard preoperative care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of postoperative complications
Analysis of the incidence of complications, including assessment according to the Clavien-Dindo classification. Analysis of complications will include the incidence of intensive care units hospitalization, frequency of reoperation, dehiscence of intestinal anastomosis, wound dehiscence with eventeration, need for blood transfusion and readmission within 30 days
Measured: from surgery for the next 30 days
Length of hospital stay
The analysis will include the length of hospitalization after surgery.
Measured: from surgery to hospital discharge (assessed up to 14 days)
Time to start adjuvant chemotherapy
Comparison of time from hospital discharge to start of adjuvant chemotherapy
Measured: from discharge from hospital for the next 2 months
Secondary outcomes (2)
Progression-free survival
Comparison of progression-free survival in both groups at 3 and 5 years of follow-up.
Measured: From the time of the operation for the next 3 and 5 years
Overall survival
Comparison of overall survival in both groups at 3 and 5 years of follow-up
Measured: From the time of the operation for the next 3 and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start1 Jul 2025 (estimated)
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2031 (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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The intervention group consists of patients undergoing prehabilitation
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Silesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcin Zębalski, Medical University of Silesia
- Investigators
- Krzysztof Nowosielski, MD, PhD, Study chair, Department of Gynecology, Obstetrics and Gynecological Oncology, University Clinical Center of the Medical University of SilesiaMarcin A Zębalski, MD, Principal investigator, Department of Gynecology, Obstetrics and Gynecological Oncology, University Clinical Center of the Medical University of Silesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07058753
- Sponsor's protocol ID
- PREH/2025-2-1
- Other IDs
- PREH/2025-2-1
- Acronym
- PREHONED
- Status last verified
- Jun 2025
- First submitted
- 23 Jun 2025
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Intense Course of Prehabilitation in Ovarian Cancer Patients During Neoadjuvant Treatment Awaiting for Interval Debulking Surgery. PREHONED - a Prospective, Randomized, Multicentre Clinical Study.
- ClinicalTrials.gov ID
- NCT07058753
- Acronym / sponsor ID
- PREHONED / PREH/2025-2-1
- Conditions
- Ovarian Cancer
- Keywords
- ovarian cancer, prehabilitation, interval debulking surgery, neoadjuvant chemotherapy
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Medical University of SilesiaUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jul 2031 (estimated)
- First posted
- 10 Jul 2025 (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.
Prehabilitation includes care for patients preparing for surgery. This is a modern approach aimed at increasing the patient's functional capacity before surgery and improving postoperative results. Prehabilitation includes preoperative physical activity, nutritional intervention, psychological support, cessation of stimulants and optimization of laboratory test results.
Many studies have shown a positive effect of prehabilitation on postoperative results, mainly reducing the number of postoperative complications and shortening the hospitalization time.
The assumed time of prehabilitation is 2-6 weeks, but in the case of oncology patients, the procedure should not be delayed only for the sake of prehabilitation.
Our study includes oncology patients with ovarian cancer who are referred for neoadjuvant chemotherapy before interval cytoreductive surgery. The assumption of the study is an intensive course of prehabilitation during neoadjuvant treatment, which should provide significantly better postoperative results.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The intervention group consists of patients undergoing prehabilitation
| Arm | Type | Receives |
|---|---|---|
| Intense course of prehabilitation | Experimental | Procedure: Prehabilitation. An intensive prehabilitation for NACT patientsPatients undergoing intense prehabilitation program |
| Standard preoperative care | No intervention | –Patients with standard preoperative care |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with confirmed ovarian cancer
- No possibility of performing primary debulking surgery (Fagotti score > 8 points). Referral patient for neoadjuvant chemotherapy
- Consent to participate in the study
- Age over 18 years
Key exclusion criteria (4 listed)
- Performing primary debulking surgery
- Lack of consent to participate in the study
- Aletti score < 4 points in interval debulking surgery
- Severe neurological/psychiatric disorders that make contact with the patient difficult
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 |
|---|---|---|
| Prehabilitation. An intensive prehabilitation for NACT patientsPatients referred to NACT (neoadjuvant chemotheraphy) for advanced ovarian cancer will undergo an intensive course of prehabilitation including physical exercise, a high-protein diet, protein and vitamin supplementation, optimization of laboratory test results, and psychological support will be provided. | Procedure or surgery | Intense course of prehabilitation |
Primary outcome
Frequency of postoperative complications
Time frame: from surgery for the next 30 days
Analysis of the incidence of complications, including assessment according to the Clavien-Dindo classification. Analysis of complications will include the incidence of intensive care units hospitalization, frequency of reoperation, dehiscence of intestinal anastomosis, wound dehiscence with eventeration, need for blood transfusion and readmission within 30 days
Length of hospital stay
Time frame: from surgery to hospital discharge (assessed up to 14 days)
The analysis will include the length of hospitalization after surgery.
Time to start adjuvant chemotherapy
Time frame: from discharge from hospital for the next 2 months
Comparison of time from hospital discharge to start of adjuvant chemotherapy
2 secondary outcomes
Progression-free survival
Time frame: From the time of the operation for the next 3 and 5 years
Overall survival
Time frame: From the time of the operation for the next 3 and 5 years
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 10 Jul 2025.
- Individual participant dataSharing planned: Undecided
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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.
Krzysztof Nowosielski, MD, PhD study chair
Department of Gynecology, Obstetrics and Gynecological Oncology, University Clinical Center of the Medical University of Silesia
Marcin A Zębalski, MD principal investigator
Department of Gynecology, Obstetrics and Gynecological Oncology, University Clinical Center of the Medical University of Silesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prehabilitation. An intensive prehabilitation for NACT patients in people with Ovarian Cancer, run by Medical University of Silesia at 1 site in Poland.
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 4 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of postoperative complications (time frame: from surgery for the next 30 days). The study lists 3 primary outcomes in all. 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 10 Jul 2025.