Clinical trial · Interventional
Extended Versus Short Prehabilitation Programme for Patients With Advanced Ovarian Cancer Undergoing Major Surgery
Efficacy of an Extended Prehabilitation Program Versus Standard in Patients With Advanced Ovarian Cancer Within ERAS Protocols
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer With Peritoneal Carcinosis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Extended (Long)-Prehabilitation | Behavioral | — | UNRESOLVED |
| Standard (Short)-Prehabilitation | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Extended (Long)-Prehabilitation
- description
- Patients allocated to the extended prehabilitation will constitute the experimental group. These patients will receive multimodal prehabilitation including but not limtied to exercise training, nutritional optimization and psychological support from start of neoadjuvant therapy until surgery
- interventionNames
- Behavioral: Extended (Long)-Prehabilitation
- type
- ACTIVE_COMPARATOR
- label
- Standard (Short)-Prehabilitation
- description
- Patients allocated to the standard prehabilitation will act as active comparator. In this group, patients will receive only general recommendations and tips during neoadjuvant therapy followed by standard prehabilitation until surgery.
- interventionNames
- Behavioral: Standard (Short)-Prehabilitation
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (10)
- BACKGROUNDMayer 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
- BACKGROUNDGarrone 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.esmoop.2024.103665. Epub 2024 Aug 8. PMID 39121813
- BACKGROUNDChen 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
- BACKGROUNDSebio-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
- BACKGROUNDDiaz-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 Study. Cancers (Basel). 2022 Mar 23;14(7):1635. doi: 10.3390/cancers14071635. PMID 35406407
- BACKGROUNDDiaz-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-2022-003652.