Prehabilitation in Ovarian Cancer Patients During Chemiotherapy Before Cytoreductive Surgery.

Not Applicable

• Conditions: Ovarian Cancer

• Registration Number: NCT07058753
• Lead Sponsor: Medical University of Silesia

Brief 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. 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

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-23
• Study First Submitted QC: 2025-06-30
• Last Update Submitted: 2025-06-30
• Study Start: 2025-07-01
• Study First Posted: 2025-07-10
• Last Update Posted: 2025-07-10
• Primary Completion: 2028-07-01
• Study Completion: 2031-07-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Frequency of postoperative complications	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	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	from discharge from hospital for the next 2 months	Comparison of time from hospital discharge to start of adjuvant chemotherapy

Secondary Outcome Measures

Name	Time	Method
Progression-free survival	From the time of the operation for the next 3 and 5 years	Comparison of progression-free survival in both groups at 3 and 5 years of follow-up.
Overall survival	From the time of the operation for the next 3 and 5 years	Comparison of overall survival in both groups at 3 and 5 years of follow-up

Trial Locations

Locations (1)

Department of Gynecology, Obstetrics and Gynecological Oncology, University Clinical Center of the Medical University of Silesia; 🇵🇱 Katowice, Poland