Prehabilitation in Ovarian Cancer Patients During Chemiotherapy Before Cytoreductive Surgery.

NCT ID: NCT07058753

Last Updated: 2025-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-01

Study Completion Date

2031-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Ovarian Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The intervention group consists of patients undergoing prehabilitation
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intense course of prehabilitation

Patients undergoing intense prehabilitation program

Group Type EXPERIMENTAL

Prehabilitation. An intensive prehabilitation for NACT patients

Intervention Type PROCEDURE

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.

Standard preoperative care

Patients with standard preoperative care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Prehabilitation. An intensive prehabilitation for NACT patients

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Silesia

OTHER

Sponsor Role lead

Responsible Party

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Marcin Zębalski

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Krzysztof Nowosielski, MD, PhD

Role: STUDY_CHAIR

Department of Gynecology, Obstetrics and Gynecological Oncology, University Clinical Center of the Medical University of Silesia

Marcin A Zębalski, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Gynecology, Obstetrics and Gynecological Oncology, University Clinical Center of the Medical University of Silesia

Locations

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Department of Gynecology, Obstetrics and Gynecological Oncology, University Clinical Center of the Medical University of Silesia

Katowice, , Poland

Site Status

Countries

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Poland

Other Identifiers

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PREH/2025-2-1

Identifier Type: REGISTRY

Identifier Source: secondary_id

PREH/2025-2-1

Identifier Type: -

Identifier Source: org_study_id

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