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

NCT07509814NOT_YET_RECRUITINGNAINTERVENTIONAL

Summary

Key Facts

Lead Sponsor

Hospital Clinic of Barcelona

Enrollment

225

Start Date

2026-04-01

Completion Date

2028-03-30

Study Type

INTERVENTIONAL

Official Title

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

Interventions

Extended (Long)-PrehabilitationStandard (Short)-Prehabilitation

Conditions

Ovarian Cancer With Peritoneal Carcinosis

Eligibility

Age Range

18 Years+

Sex

FEMALE

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)

Outcome Measures

Primary Outcomes

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

Secondary Outcomes

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

Locations

Hospital Universitario Germans Trias i Pujol, Badalona, Spain

Hospital Clinic of Barcelona, Barcelona, Spain

Hospital Universitario 12 de Octubre, Madrid, Spain

Hospital Universitario Navarra, Pamplona, Spain

Hospital Universitario y Politécnico La Fe, Valencia, Spain

Linked Papers

2025-04-19

Multimodal prehabilitation improves functional capacity in patients with advanced ovarian cancer undergoing cytoreductive surgery

Prehabilitation, defined as the preparatory intervention to increase patient preparedness in the lead-up to surgery, has shown a decrease in post-operative complications in various types of surgery. However, there is limited evidence in advanced ovarian cancer surgery. This study aimed to evaluate the benefits of multimodal prehabilitation in advanced ovarian cancer patients in terms of improving physical functioning, body composition, and psychological well-being during the pre-operative period. This single-center, ambispective study included patients with advanced ovarian cancer eligible for primary or interval cytoreductive surgery. Participants attended a multimodal prehabilitation program comprising medical optimization, supervised exercise training, nutritional counseling and supplementation, and psychological support. Functional capacity, nutritional status, and psychological well-being were assessed before the start of the program and before surgery. 62 patients were referred for the multimodal prehabilitation program from July 2019 to May 2023. Median adherence to the training program reached 75% (IQR 58-87%). 35 patients (59%) were evaluated pre-operatively. Patients attended a median of 8 (IQR 6-12) supervised exercise training sessions with no differences between those who underwent primary or interval cytoreductive surgery (p=0.80). A significant improvement was observed in functional capacity according to the 6 min walk test (mean 33.1 m, 95% CI 10.5 to 55.5) as well as in the 30 s sit-to-stand test (+3.3 repetitions, 95% CI 1.8 to 4.8), with both being above the minimal clinically important difference of 14 m and two repetitions, respectively. Patients also reported a significant decrease in depression, anxiety, and total scores of the Hospital Anxiety and Depression Scale. Multimodal prehabilitation in patients with advanced ovarian cancer undergoing cytoreductive surgery improves pre-operative physical functioning and decreases emotional distress. Further controlled studies with a larger sample size are warranted to corroborate improvement in functional capacity, body composition, and psychological well-being through prehabilitation programs.