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.
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
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)
Parallel
Extended (Long)-Prehabilitation
BehavioralIn 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
BehavioralStandard (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
Comprehensive Complication Index (CCI)
Aggregate score including all postoperative complications and their severity
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
Treatment-related toxicities
Number and severity (CTCAE v5) of treatment-related toxicities during neoadjuvant therapy will be retrieved in both groups from medical records.
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
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
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
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Hospital Clinic of Barcelona
Lead sponsor
Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Spain
Collaborator
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