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ClinicalTrials.gov ID

NCT07509814

Lead Sponsor

Hospital Clinic of BarcelonaOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

225Estimated

Last Update Posted

Apr 3, 2026Actual

Start Date

Apr 1, 2026Estimated

Primary Completion Date

Mar 30, 2028Estimated

Completion Date

Dec 31, 2028Estimated

Official Title

Efficacy of an Extended Prehabilitation Program Versus Standard in Patients With Advanced Ovarian Cancer Within ERAS Protocols

Brief Summary

Standard treatment for advanced ovarian cancer includes a combination of cytotoxic chemotherapy and citorreductive surgery. During neo-adjuvant administration of chemotherapy, many patients experience a decline in their functional capacity, leading to an increased risk of postoperative complication as a combination of potential malnutrition, decreased physical activity levels and increased anxiety. Prehabilitation programs conducted within Enhanced Rescovery After Surgery (ERAS) pathways have shown to reduce postoperative complications and length of hospital stay in a diverse group of cancer surgeries and, according to some preliminary evidence, can also increase tumour response in patients receiving neoadjuvant chemotherapy. The aim of this study is to compare two modalities of prehabilitation (extended versus estandard) on postoperative complications and response to neoadjuvant chemotherapy. A total of 225 patients will be randomized in a 2:1 ratio to extended prehabilitation (initiated at the onset of neoadjuvant therapy) or standard prehabilitation (initiated after the course of neoadjuvant therapy is completed). In both groups the prehabilitation program will be delivered in the same manner, including supervised (virtual or facility-based) exercise training, nutritional optimization and psychological support and will be supported by a digital platform.

• Ovarian Cancer With Peritoneal Carcinosis

• Extended (Long)-Prehabilitation
• Standard (Short)-Prehabilitation

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

Female

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• Patients diagnosed with advanced ovarian cancer (FIGO III and IV)
• Clinical indication of neoadjuvant chemotherapy followed by cytoreductive surgery
• No contraindications for exercise training
• Give written consent to participate

Exclusion Criteria:

• Patients diagnosed with advanced ovarian cancer scheduled for cytoredutive surgery followed by chemotherapy (no neoadjuvant)
• Patients with deteriorated functional state (ECOG ≥2) or those with contraindication to exercise training (severe or unstable cardiorespiratory, metabolic, musculoskeletal or neurological conditions)

Primary Purpose

Supportive Care

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Single

Lead Sponsor

Hospital Clinic of BarcelonaOTHER

Collaborators

Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), SpainUNKNOWN

sebio@clinic.cat0034 634787194

jc.muruzabal.torquemada@navarra.es0034 848422222