Ovarian Cancer With Peritoneal Carcinosis
Conditions
Keywords
Prehabilitation, Neoadjuvant Therapy, Interval surgery, Postoperative Complications, Treatment response
Brief summary
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
BEHAVIORALExtended (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 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.
BEHAVIORALStandard (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
Sponsors
Hospital Clinic of Barcelona
Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Spain
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
Assessors conducting major pathological analyses as well as reviewing medical records of patients for postoperative complications will be blinded to the patients' allocation. Nor the patients or the therapists will be blinded given the nature of the intervention.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comprehensive Complication Index (CCI) | Post-surgery within 30 days | Aggregate score including all postoperative complications and their severity |
| CA-125 Elimination Rate Constant K (KELIM) | Before surgery | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment-related toxicities | Post-neoadjuvant therapy within three weeks after last cycle | 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 | Post-surgery within two weeks | 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 | Intraoperatively at the end of surgery | The number of complete tumour resection surgeries (R0) achieved in each group will be recorded at the time of surgery |
| Postoperative Functional Recovery | 30 days after surgery | 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 |
| Overall Health-Related Quality of Life | After neoadjuvant therapy within two weeks after last cycle | Overall health-Related Quality of Life measured with a general (EORTC QLQ C30) will be captured at baseline (T0) and after neoadjuvant therapy (T1) |
| Disease-specific Health Related Quality of Life | After neoadjuvant therapy within two weeks of the last cycle | Disease-specific health related quality of life will be measured with the EORTC QLQ OV28 at baseline (T0) and after neoadjuvant therapy (T1) |
| Overall survival | 36 months after surgery | Overall survival (OS) will be recorded in both groups up to 36 months after surgery. |
| Disease-free Survival (DFS) | 36 months after surgery | Disease-Free Survival (DFS) will be recorded in both groups up to 36 months after surgery. |
Countries
Spain
Contacts
CONTACTBerta Díaz Feijoo, PhD
CONTACTRaquel Sebio Garcia, PhD
Outcome results
None listed