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NCT Number: NCT07509814

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

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.

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Key information

Conditions

Ovarian Cancer With Peritoneal Carcinosis Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Germans Trias i Pujol, Badalona, Barcelona, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Extended (Long)-Prehabilitation

Behavioral

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.

Other names: Nutritional optimization, Psychological Support, Perioperative care, Exercise Therapy

Standard (Short)-Prehabilitation

Behavioral

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

Other names: Perioperative Care, Preoperative Exercise, Nutritional Optimization, Psychological Support

Primary outcomes

  1. Comprehensive Complication Index (CCI)

    Time frame: Post-surgery within 30 days

    Aggregate score including all postoperative complications and their severity

  2. CA-125 Elimination Rate Constant K (KELIM)

    Time frame: 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 outcomes

  1. Treatment-related toxicities

    Time frame: 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.

  2. Response to neoadjuvant therapy

    Time frame: 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

  3. Rate of Complete tumour resection surgeries

    Time frame: 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

  4. Postoperative Functional Recovery

    Time frame: 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

  5. Overall Health-Related Quality of Life

    Time frame: 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)

  6. Disease-specific Health Related Quality of Life

    Time frame: 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)

  7. Overall survival

    Time frame: 36 months after surgery

    Overall survival (OS) will be recorded in both groups up to 36 months after surgery.

  8. Disease-free Survival (DFS)

    Time frame: 36 months after surgery

    Disease-Free Survival (DFS) will be recorded in both groups up to 36 months after surgery.

Study contacts

Contact information is provided by the study sponsor or research team.

Berta Díaz Feijoo, PhD

CONTACT

[email protected]

0034 932275400

Raquel Sebio Garcia, PhD

CONTACT

[email protected]

0034 634787194

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Collaborators

  • Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Spain

Registry information

Official study title

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

Acronym: SOPHIE II

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 3, 2026
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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