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

Official title

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

Overview

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.

Interventions

• Behavioral Extended (Long)-Prehabilitation
  In this study, multimodal prehabilitation will be delivered throughout the course of neoadjuvant therapy and until surgery in the Extended-Prehabilitation arm, while the control group will only receive the intervention once neoadjuvant therapy is completed and the indication for surgery has been confirmed by the multidisciplinary tumour board. The intervention will consist of three major pillars: a) supervised (virtual or facility-based) exercise training twice a week; b) individual nutritional
• Behavioral Standard (Short)-Prehabilitation
  Standard (short) prehabilitation will include the same three pillars (exercise training twice weekly, individual nutritional counselling and supplementation and psychological support delivered only at the end of neoadjuvant therapy and until surgery (approximately 3-4 weeks). Additional interventions such as smoking cessation and iron optimization will also be included if deemed neccessary in accordance with hospitals' standard of care

Primary outcome measures

• Comprehensive Complication Index (CCI) [Time frame: Post-surgery within 30 days]
• CA-125 Elimination Rate Constant K (KELIM) [Time frame: Before surgery]

Secondary outcome measures (8)

• Treatment-related toxicities [Time frame: Post-neoadjuvant therapy within three weeks after last cycle]
• Response to neoadjuvant therapy [Time frame: Post-surgery within two weeks]
• Rate of Complete tumour resection surgeries [Time frame: Intraoperatively at the end of surgery]
• Postoperative Functional Recovery [Time frame: 30 days after surgery]
• Overall Health-Related Quality of Life [Time frame: After neoadjuvant therapy within two weeks after last cycle]
• Disease-specific Health Related Quality of Life [Time frame: After neoadjuvant therapy within two weeks of the last cycle]
• Overall survival [Time frame: 36 months after surgery]
• Disease-free Survival (DFS) [Time frame: 36 months after surgery]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Supportive care

Study locations

Spain · 5 centers

• Hospital Universitario Germans Trias i Pujol — Badalona
• Hospital Clinic of Barcelona — Barcelona
• Hospital Universitario 12 de Octubre — Madrid
• Hospital Universitario Navarra — Pamplona
• Hospital Universitario y Politécnico La Fe — Valencia

Publications

• Mayer A, Cibula D. Optimizing prehabilitation in gynecologic malignancies: Improving acceptance, overcoming barriers, and managing program complexity. Eur J Surg Oncol. 2024 Dec;50(12):108739. doi: 10.1016/j.ejso.2024.108739. Epub 2024 Oct 2. PMID 39418833
• Garrone O, Paccagnella M, Abbona A, Ruatta F, Vanella P, Denaro N, Tomasello G, Croce N, Barbin F, Rossino MG, La Porta CAM, Sapino A, Torri V, Albini A, Merlano MC. Moderate physical activity during neoadjuvant chemotherapy in breast cancer patients: effect on cancer-related inflammation and pathological complete response-the Neo-Runner study. ESMO Open. 2024 Aug;9(8):103665. doi: 10.1016/j.esmoo PMID 39121813
• Chen Y, Sebio-Garcia R, Iglesias-Garcia E, Reguart N, Martinez-Palli G, Bello I. Prehabilitation for patients undergoing neoadjuvant therapy prior to cancer resection: a systematic review and meta-analysis. Support Care Cancer. 2024 Oct 28;32(11):749. doi: 10.1007/s00520-024-08941-1. PMID 39466349
• Sebio-Garcia R, Celada-Castro C, Arguis MJ, Siso M, Torne A, Tena B, Diaz-Feijoo B, Martinez-Palli G. Multimodal prehabilitation improves functional capacity in patients with advanced ovarian cancer undergoing cytoreductive surgery. Int J Gynecol Cancer. 2026 Jan;36(1):101858. doi: 10.1136/ijgc-2024-005686. Epub 2025 Apr 19. PMID 39375165
• Diaz-Feijoo B, Agusti-Garcia N, Sebio R, Lopez-Hernandez A, Siso M, Glickman A, Carreras-Dieguez N, Fuste P, Marina T, Martinez-Egea J, Aguilera L, Perdomo J, Pelaez A, Lopez-Baamonde M, Navarro-Ripoll R, Gimeno E, Campero B, Torne A, Martinez-Palli G, Arguis MJ. Feasibility of a Multimodal Prehabilitation Programme in Patients Undergoing Cytoreductive Surgery for Advanced Ovarian Cancer: A Pilot PMID 35406407
• Diaz-Feijoo B, Agusti N, Sebio R, Siso M, Carreras-Dieguez N, Domingo S, Diaz-Cambronero O, Torne A, Martinez-Palli G, Arguis MJ. A multimodal prehabilitation program for the reduction of post-operative complications after surgery in advanced ovarian cancer under an ERAS pathway: a randomized multicenter trial (SOPHIE). Int J Gynecol Cancer. 2022 Nov 7;32(11):1463-1468. doi: 10.1136/ijgc-2022-0036 PMID 35793862
• Nelson G, Fotopoulou C, Taylor J, Glaser G, Bakkum-Gamez J, Meyer LA, Stone R, Mena G, Elias KM, Altman AD, Bisch SP, Ramirez PT, Dowdy SC. Enhanced recovery after surgery (ERAS(R)) society guidelines for gynecologic oncology: Addressing implementation challenges - 2023 update. Gynecol Oncol. 2023 Jun;173:58-67. doi: 10.1016/j.ygyno.2023.04.009. Epub 2023 Apr 21. PMID 37086524
• Querleu D, Planchamp F, Chiva L, Fotopoulou C, Barton D, Cibula D, Aletti G, Carinelli S, Creutzberg C, Davidson B, Harter P, Lundvall L, Marth C, Morice P, Rafii A, Ray-Coquard I, Rockall A, Sessa C, van der Zee A, Vergote I, duBois A. European Society of Gynaecological Oncology (ESGO) Guidelines for Ovarian Cancer Surgery. Int J Gynecol Cancer. 2017 Sep;27(7):1534-1542. doi: 10.1097/IGC.00000000 PMID 30814245

Identifiers

NCT: NCT07509814 · HCB-2025-0370

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗