Extended Versus Short Prehabilitation Programme for Patients With Advanced Ovarian Cancer Undergoing Major Surgery

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorHospital Clinic of Barcelona

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

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

Treatment groups

225 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Hospital Clinic of Barcelona

Lead sponsor

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

Collaborator