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| Name | Class |
|---|---|
| Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Spain | UNKNOWN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Comprehensive Complication Index (CCI) | Aggregate score including all postoperative complications and their severity | 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 | Before surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-related toxicities | Number and severity (CTCAE v5) of treatment-related toxicities during neoadjuvant therapy will be retrieved in both groups from medical records. | Post-neoadjuvant therapy within three weeks after last cycle |
| Response to neoadjuvant therapy |
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Inclusion Criteria:
Exclusion Criteria:
Ovarian cancer affects only to biological women
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Berta Díaz Feijoo, PhD | Contact | 0034 932275400 | bdiazfe@clinic.cat | |
| Raquel Sebio Garcia, PhD | Contact | 0034 634787194 | sebio@clinic.cat |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Germans Trias i Pujol | Badalona | Barcelona | 08916 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39418833 | Background | 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. | |
| 39121813 | Background | Garrone 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. |
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IPD might be shared if considered of interest for future research studies and/or individual metaanalyses.
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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.
|
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| 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 |
|
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Chemotherapy Response Score (CRS) at pathological analysis will be assessed to globally ascertain the response of neoadjuvant chemotherapy in both groups |
| 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 | 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 | 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) | 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) | 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. | 36 months after surgery |
| Disease-free Survival (DFS) | Disease-Free Survival (DFS) will be recorded in both groups up to 36 months after surgery. | 36 months after surgery |
| Hospital Clinic of Barcelona | Barcelona | Barcelona | 08036 | Spain |
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| Hospital Universitario 12 de Octubre | Madrid | Madrid | 28041 | Spain |
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| Hospital Universitario Navarra | Pamplona | Navarre | 31008 | Spain |
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| Hospital Universitario y Politécnico La Fe | Valencia | Valencia | 46026 | Spain |
|
| 39466349 | Background | Chen 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. |
| 39375165 | Background | Sebio-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. |
| 35406407 | Background | Diaz-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. |
| 35793862 | Background | Diaz-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. |
| 37086524 | Background | Nelson 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. |
| 30814245 | Background | Querleu 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. |
| 31048403 | Background | Colombo 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. |
| 40908761 | Background | Renz 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. |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019990 | Perioperative Care |
| D005081 | Exercise Therapy |
| D000082622 | Preoperative Exercise |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D026741 | Physical Therapy Modalities |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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