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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
225
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 counselling and supplementation; c) individual or group-based support based on the needs and preferences of the patients. Additional interventions according to the centre standard of care such as iron optimization and smoking cessation will be provided if needed.
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
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital Clinic of Barcelona
Barcelona, Barcelona, Spain
Hospital Universitario 12 de Octubre
Madrid, Madrid, Spain
Hospital Universitario Navarra
Pamplona, Navarre, Spain
Hospital Universitario y Politécnico La Fe
Valencia, Valencia, Spain
Comprehensive Complication Index (CCI)
Aggregate score including all postoperative complications and their severity
Time frame: Post-surgery within 30 days
CA-125 Elimination Rate Constant K (KELIM)
Changes in tumour antigen CA-125 over time (KELIM) will be recorded as a proxy to assess response to neoadjuvant cytotoxic therapy in both arms
Time frame: Before surgery
Treatment-related toxicities
Number and severity (CTCAE v5) of treatment-related toxicities during neoadjuvant therapy will be retrieved in both groups from medical records.
Time frame: Post-neoadjuvant therapy within three weeks after last cycle
Response to neoadjuvant therapy
Chemotherapy Response Score (CRS) at pathological analysis will be assessed to globally ascertain the response of neoadjuvant chemotherapy in both groups
Time frame: Post-surgery within two weeks
Rate of Complete tumour resection surgeries
The number of complete tumour resection surgeries (R0) achieved in each group will be recorded at the time of surgery
Time frame: Intraoperatively at the end of surgery
Postoperative Functional Recovery
Length of hospital stay, Days Out of Hospital at 30 Days (DAOH30) and time to start adjuvant chemotherapy after surgery will be measured to determine the functional recovery of patient after interval surgery
Time frame: 30 days after surgery
Overall Health-Related Quality of Life
Overall health-Related Quality of Life measured with a general (EORTC QLQ C30) will be captured at baseline (T0) and after neoadjuvant therapy (T1)
Time frame: After neoadjuvant therapy within two weeks after last cycle
Disease-specific Health Related Quality of Life
Disease-specific health related quality of life will be measured with the EORTC QLQ OV28 at baseline (T0) and after neoadjuvant therapy (T1)
Time frame: After neoadjuvant therapy within two weeks of the last cycle
Overall survival
Overall survival (OS) will be recorded in both groups up to 36 months after surgery.
Time frame: 36 months after surgery
Disease-free Survival (DFS)
Disease-Free Survival (DFS) will be recorded in both groups up to 36 months after surgery.
Time frame: 36 months after surgery
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