Ovarian Cancer With Peritoneal CarcinosisSOPHIE IINCT07509814
Extended Versus Short Prehabilitation Programme for Patients With Advanced Ovarian Cancer Undergoing Major Surgery
A study testing Extended (Long)-Prehabilitation and Standard (Short)-Prehabilitation in people with Ovarian Cancer With Peritoneal Carcinosis, run by Hospital Clinic of Barcelona at 5 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer With Peritoneal Carcinosis
- What is being tested?
- Extended (Long)-Prehabilitation and Standard (Short)-Prehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 5 sitesSpain
- Study dates
- 1 Apr 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Spain5 sites
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, 08916
Enrique Moret, PhD, 0034 934651200, emoret.germanstrias@gencat.cat
Enrique Moret, PhD
Hospital Clinic of Barcelona
Barcelona, Barcelona, 08036
Raquel Sebio Garcia, PhD, 0034 634787194, sebio@clinic.cat
Berta Díaz Feijoo, PhD
Hospital Universitario 12 de Octubre
Madrid, Madrid, 28041
Álvaro Tejerizo, PhD, 0034 913908000, alvaro.tejerizo@salud.madrid.org
Álvaro Tejerizo, PhD
Hospital Universitario Navarra
Pamplona, Navarre, 31008
Juan Carlos Muruzabal, PhD, 0034 848422222, jc.muruzabal.torquemada@navarra.es
Juan Carlos Muruzabal, PhD
Hospital Universitario y Politécnico La Fe
Valencia, Valencia, 46026
Santiago Domingo Del Pozo, PhD, 0034 961244000, santiago.domingo.delpozo@gmail.com
Santiago Domingo Del Pozo, PhD
About this study
Official title: Efficacy of an Extended Prehabilitation Program Versus Standard in Patients With Advanced Ovarian Cancer Within ERAS Protocols
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.
- Being tested
- Extended (Long)-Prehabilitation, Standard (Short)-Prehabilitation
- Keywords
- Prehabilitation, Neoadjuvant Therapy, Interval surgery, Postoperative Complications, Treatment response
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extended (Long)-PrehabilitationBehavioural
Also called Nutritional optimization, Psychological Support, Perioperative care, Exercise Therapy
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)-PrehabilitationBehavioural
Also called Perioperative Care, Preoperative Exercise, Nutritional Optimization, Psychological Support
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
| Study group | Role | What they receive |
|---|---|---|
| Extended (Long)-Prehabilitation | Experimental | Patients allocated to the extended prehabilitation will constitute the experimental group. These patients will receive multimodal prehabilitation including but not limtied to exercise training, nutritional optimization and psychological support from start of neoadjuvant therapy until surgery Receives: Behavioral: Extended (Long)-Prehabilitation |
| Standard (Short)-Prehabilitation | Active comparator | Patients allocated to the standard prehabilitation will act as active comparator. In this group, patients will receive only general recommendations and tips during neoadjuvant therapy followed by standard prehabilitation until surgery. Receives: Behavioral: Standard (Short)-Prehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comprehensive Complication Index (CCI)
Aggregate score including all postoperative complications and their severity
Measured: 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
Measured: Before surgery
Secondary outcomes (8)
Treatment-related toxicities
Number and severity (CTCAE v5) of treatment-related toxicities during neoadjuvant therapy will be retrieved in both groups from medical records.
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 36 months after surgery
Disease-free Survival (DFS)
Disease-Free Survival (DFS) will be recorded in both groups up to 36 months after surgery.
Measured: 36 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study start1 Apr 2026 (estimated)
- Primary completion30 Mar 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Ovarian Cancer With Peritoneal CarcinosisStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Spain
- Responsible party
- Principal investigator, Berta Diaz-Feijoo, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07509814
- Sponsor's protocol ID
- HCB-2025-0370
- Acronym
- SOPHIE II
- Status last verified
- Mar 2026
- First submitted
- 5 Mar 2026
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD might be shared if considered of interest for future research studies and/or individual metaanalyses.
Publications
Mayer A, Cibula D. Optimizing prehabilitation in gynecologic malignancies: Improving acceptance, overcoming barriers, and managing program complexity. Eur J Surg Oncol. 2024 Dec;50(12):108739. doi: 10.1016/j.ejso.2024.108739. Epub 2024 Oct 2.
PubMed 39418833Garrone O, Paccagnella M, Abbona A, Ruatta F, Vanella P, Denaro N, Tomasello G, Croce N, Barbin F, Rossino MG, La Porta CAM, Sapino A, Torri V, Albini A, Merlano MC. Moderate physical activity during neoadjuvant chemotherapy in breast cancer patients: effect on cancer-related inflammation and pathological complete response-the Neo-Runner study. ESMO Open. 2024 Aug;9(8):103665. doi: 10.1016/j.esmoop.2024.103665. Epub 2024 Aug 8.
PubMed 39121813Chen Y, Sebio-Garcia R, Iglesias-Garcia E, Reguart N, Martinez-Palli G, Bello I. Prehabilitation for patients undergoing neoadjuvant therapy prior to cancer resection: a systematic review and meta-analysis. Support Care Cancer. 2024 Oct 28;32(11):749. doi: 10.1007/s00520-024-08941-1.
PubMed 39466349Sebio-Garcia R, Celada-Castro C, Arguis MJ, Siso M, Torne A, Tena B, Diaz-Feijoo B, Martinez-Palli G. Multimodal prehabilitation improves functional capacity in patients with advanced ovarian cancer undergoing cytoreductive surgery. Int J Gynecol Cancer. 2026 Jan;36(1):101858. doi: 10.1136/ijgc-2024-005686. Epub 2025 Apr 19.
PubMed 39375165Diaz-Feijoo B, Agusti-Garcia N, Sebio R, Lopez-Hernandez A, Siso M, Glickman A, Carreras-Dieguez N, Fuste P, Marina T, Martinez-Egea J, Aguilera L, Perdomo J, Pelaez A, Lopez-Baamonde M, Navarro-Ripoll R, Gimeno E, Campero B, Torne A, Martinez-Palli G, Arguis MJ. Feasibility of a Multimodal Prehabilitation Programme in Patients Undergoing Cytoreductive Surgery for Advanced Ovarian Cancer: A Pilot Study. Cancers (Basel). 2022 Mar 23;14(7):1635. doi: 10.3390/cancers14071635.
PubMed 35406407Diaz-Feijoo B, Agusti N, Sebio R, Siso M, Carreras-Dieguez N, Domingo S, Diaz-Cambronero O, Torne A, Martinez-Palli G, Arguis MJ. A multimodal prehabilitation program for the reduction of post-operative complications after surgery in advanced ovarian cancer under an ERAS pathway: a randomized multicenter trial (SOPHIE). Int J Gynecol Cancer. 2022 Nov 7;32(11):1463-1468. doi: 10.1136/ijgc-2022-003652.
PubMed 35793862Nelson G, Fotopoulou C, Taylor J, Glaser G, Bakkum-Gamez J, Meyer LA, Stone R, Mena G, Elias KM, Altman AD, Bisch SP, Ramirez PT, Dowdy SC. Enhanced recovery after surgery (ERAS(R)) society guidelines for gynecologic oncology: Addressing implementation challenges - 2023 update. Gynecol Oncol. 2023 Jun;173:58-67. doi: 10.1016/j.ygyno.2023.04.009. Epub 2023 Apr 21.
PubMed 37086524Querleu D, Planchamp F, Chiva L, Fotopoulou C, Barton D, Cibula D, Aletti G, Carinelli S, Creutzberg C, Davidson B, Harter P, Lundvall L, Marth C, Morice P, Rafii A, Ray-Coquard I, Rockall A, Sessa C, van der Zee A, Vergote I, duBois A. European Society of Gynaecological Oncology (ESGO) Guidelines for Ovarian Cancer Surgery. Int J Gynecol Cancer. 2017 Sep;27(7):1534-1542. doi: 10.1097/IGC.0000000000001041.
PubMed 30814245Colombo N, Sessa C, Bois AD, Ledermann J, McCluggage WG, McNeish I, Morice P, Pignata S, Ray-Coquard I, Vergote I, Baert T, Belaroussi I, Dashora A, Olbrecht S, Planchamp F, Querleu D; ESMO-ESGO Ovarian Cancer Consensus Conference Working Group. ESMO-ESGO consensus conference recommendations on ovarian cancer: pathology and molecular biology, early and advanced stages, borderline tumours and recurrent disease. Int J Gynecol Cancer. 2019 May 7;29(4):728-760. doi: 10.1136/ijgc-2019-000308.
PubMed 31048403Renz M, Friedlander M, Berek JS. Cancer of the ovary, fallopian tube, and peritoneum: 2025 update. Int J Gynaecol Obstet. 2025 Sep;171 Suppl 1(Suppl 1):6-35. doi: 10.1002/ijgo.70282.
PubMed 40908761
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of an Extended Prehabilitation Program Versus Standard in Patients With Advanced Ovarian Cancer Within ERAS Protocols
- ClinicalTrials.gov ID
- NCT07509814
- Acronym / sponsor ID
- SOPHIE II / HCB-2025-0370
- Keywords
- Prehabilitation, Neoadjuvant Therapy, Interval surgery, Postoperative Complications, Treatment response
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Collaborators
- Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Spain
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 30 Mar 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 3 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extended (Long)-Prehabilitation | Experimental | Behavioral: Extended (Long)-PrehabilitationPatients allocated to the extended prehabilitation will constitute the experimental group. These patients will receive multimodal prehabilitation including but not limtied to exercise training, nutritional optimization and psychological support from start of neoadjuvant therapy until surgery |
| Standard (Short)-Prehabilitation | Active comparator | Behavioral: Standard (Short)-PrehabilitationPatients allocated to the standard prehabilitation will act as active comparator. In this group, patients will receive only general recommendations and tips during neoadjuvant therapy followed by standard prehabilitation until surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extended (Long)-PrehabilitationAlso: Nutritional optimization, Psychological Support, Perioperative care, Exercise TherapyIn 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. | Behavioural | Extended (Long)-Prehabilitation |
| Standard (Short)-PrehabilitationAlso: Perioperative Care, Preoperative Exercise, Nutritional Optimization, Psychological SupportStandard (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 | Behavioural | Standard (Short)-Prehabilitation |
Primary outcome
Comprehensive Complication Index (CCI)
Time frame: Post-surgery within 30 days
Aggregate score including all postoperative complications and their severity
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
8 secondary outcomes
Treatment-related toxicities
Time frame: Post-neoadjuvant therapy within three weeks after last cycle
Response to neoadjuvant therapy
Time frame: Post-surgery within two weeks
Rate of Complete tumour resection surgeries
Time frame: Intraoperatively at the end of surgery
Postoperative Functional Recovery
Time frame: 30 days after surgery
Overall Health-Related Quality of Life
Time frame: After neoadjuvant therapy within two weeks after last cycle
Disease-specific Health Related Quality of Life
Time frame: After neoadjuvant therapy within two weeks of the last cycle
Overall survival
Time frame: 36 months after surgery
Disease-free Survival (DFS)
Time frame: 36 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Background: PubMed 39418833Mayer A, Cibula D. Optimizing prehabilitation in gynecologic malignancies: Improving acceptance, overcoming barriers, and managing program complexity. Eur J Surg Oncol. 2024 Dec;50(12):108739. doi: 10.1016/j.ejso.2024.108739. Epub 2024 Oct 2.
- Background: PubMed 39121813Garrone O, Paccagnella M, Abbona A, Ruatta F, Vanella P, Denaro N, Tomasello G, Croce N, Barbin F, Rossino MG, La Porta CAM, Sapino A, Torri V, Albini A, Merlano MC. Moderate physical activity during neoadjuvant chemotherapy in breast cancer patients: effect on cancer-related inflammation and pathological complete response-the Neo-Runner study. ESMO Open. 2024 Aug;9(8):103665. doi: 10.1016/j.esmoop.2024.103665. Epub 2024 Aug 8.
- Background: PubMed 39466349Chen Y, Sebio-Garcia R, Iglesias-Garcia E, Reguart N, Martinez-Palli G, Bello I. Prehabilitation for patients undergoing neoadjuvant therapy prior to cancer resection: a systematic review and meta-analysis. Support Care Cancer. 2024 Oct 28;32(11):749. doi: 10.1007/s00520-024-08941-1.
- Background: PubMed 39375165Sebio-Garcia R, Celada-Castro C, Arguis MJ, Siso M, Torne A, Tena B, Diaz-Feijoo B, Martinez-Palli G. Multimodal prehabilitation improves functional capacity in patients with advanced ovarian cancer undergoing cytoreductive surgery. Int J Gynecol Cancer. 2026 Jan;36(1):101858. doi: 10.1136/ijgc-2024-005686. Epub 2025 Apr 19.
- Background: PubMed 35406407Diaz-Feijoo B, Agusti-Garcia N, Sebio R, Lopez-Hernandez A, Siso M, Glickman A, Carreras-Dieguez N, Fuste P, Marina T, Martinez-Egea J, Aguilera L, Perdomo J, Pelaez A, Lopez-Baamonde M, Navarro-Ripoll R, Gimeno E, Campero B, Torne A, Martinez-Palli G, Arguis MJ. Feasibility of a Multimodal Prehabilitation Programme in Patients Undergoing Cytoreductive Surgery for Advanced Ovarian Cancer: A Pilot Study. Cancers (Basel). 2022 Mar 23;14(7):1635. doi: 10.3390/cancers14071635.
- Background: PubMed 35793862Diaz-Feijoo B, Agusti N, Sebio R, Siso M, Carreras-Dieguez N, Domingo S, Diaz-Cambronero O, Torne A, Martinez-Palli G, Arguis MJ. A multimodal prehabilitation program for the reduction of post-operative complications after surgery in advanced ovarian cancer under an ERAS pathway: a randomized multicenter trial (SOPHIE). Int J Gynecol Cancer. 2022 Nov 7;32(11):1463-1468. doi: 10.1136/ijgc-2022-003652.
- Background: PubMed 37086524Nelson G, Fotopoulou C, Taylor J, Glaser G, Bakkum-Gamez J, Meyer LA, Stone R, Mena G, Elias KM, Altman AD, Bisch SP, Ramirez PT, Dowdy SC. Enhanced recovery after surgery (ERAS(R)) society guidelines for gynecologic oncology: Addressing implementation challenges - 2023 update. Gynecol Oncol. 2023 Jun;173:58-67. doi: 10.1016/j.ygyno.2023.04.009. Epub 2023 Apr 21.
- Background: PubMed 30814245Querleu D, Planchamp F, Chiva L, Fotopoulou C, Barton D, Cibula D, Aletti G, Carinelli S, Creutzberg C, Davidson B, Harter P, Lundvall L, Marth C, Morice P, Rafii A, Ray-Coquard I, Rockall A, Sessa C, van der Zee A, Vergote I, duBois A. European Society of Gynaecological Oncology (ESGO) Guidelines for Ovarian Cancer Surgery. Int J Gynecol Cancer. 2017 Sep;27(7):1534-1542. doi: 10.1097/IGC.0000000000001041.
- Background: PubMed 31048403Colombo N, Sessa C, Bois AD, Ledermann J, McCluggage WG, McNeish I, Morice P, Pignata S, Ray-Coquard I, Vergote I, Baert T, Belaroussi I, Dashora A, Olbrecht S, Planchamp F, Querleu D; ESMO-ESGO Ovarian Cancer Consensus Conference Working Group. ESMO-ESGO consensus conference recommendations on ovarian cancer: pathology and molecular biology, early and advanced stages, borderline tumours and recurrent disease. Int J Gynecol Cancer. 2019 May 7;29(4):728-760. doi: 10.1136/ijgc-2019-000308.
- Background: PubMed 40908761Renz M, Friedlander M, Berek JS. Cancer of the ovary, fallopian tube, and peritoneum: 2025 update. Int J Gynaecol Obstet. 2025 Sep;171 Suppl 1(Suppl 1):6-35. doi: 10.1002/ijgo.70282.
- Individual participant dataSharing planned: Yes. IPD might be shared if considered of interest for future research studies and/or individual metaanalyses.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extended (Long)-Prehabilitation and Standard (Short)-Prehabilitation in people with Ovarian Cancer With Peritoneal Carcinosis, run by Hospital Clinic of Barcelona at 5 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Berta Díaz Feijoo, PhD (0034 932275400, bdiazfe@clinic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comprehensive Complication Index (CCI) (time frame: Post-surgery within 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07509814, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.