Prehabilitation in Ovarian Cancer Patients During Chemiotherapy Before Cytoreductive Surgery.

NCT07058753 | Enrolling By Invitation

• 1 other identifier: PREH/2025-2-1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Cancer

Keywords

ovarian cancer; prehabilitation; interval debulking surgery; neoadjuvant chemotherapy

Outcome Measures

Primary Outcomes (3)

• 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

  from surgery for the next 30 days

• Length of hospital stay

  The analysis will include the length of hospitalization after surgery.

  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

  from discharge from hospital for the next 2 months

Secondary Outcomes (2)

• Progression-free survival

  From the time of the operation for the next 3 and 5 years

• Overall survival

  From the time of the operation for the next 3 and 5 years

Other Outcomes (2)

• Quality of life assessment

  From study enrollment to surgery (up to 4 months)

• Depression and anxiety assessment

  from study enrollment to surgery (up to 4 months)

Study Arms (2)

Intense course of prehabilitation

EXPERIMENTAL

Patients undergoing intense prehabilitation program

Procedure: Prehabilitation. An intensive prehabilitation for NACT patients

Standard preoperative care

NO INTERVENTION

Patients with standard preoperative care

Interventions

Prehabilitation. An intensive prehabilitation for NACT patients 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.

Intense course of prehabilitation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Silesia: lead

Study Sites (1)

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

Katowice, 40-752, Poland

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Krzysztof Nowosielski, MD, PhD

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

  STUDY CHAIR

• Marcin A Zębalski, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: The intervention group consists of patients undergoing prehabilitation

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: July 10, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2031
• Last Updated: July 10, 2025

Record last verified: 2025-06

Locations

PL (1)