The KORE-INNOVATION trial, a prospective controlled multi-site clinical study to implement and assess the effects of an innovative peri-operative care pathway for patients with ovarian cancer: rationale, methods and trial design.

Enrico Daehnert, Stephanie Schneider, Philipp Harter, Radoslav Chekerov, Beyhan Ataseven, Florian Heitz, Andrea Krull, Lena Zwantleitner, Adak Pirmorady Sehouli, Engi Algharably, Björn Nunier, Susanne Rolker, Barbora Knappe-Drzikova, Manuela Zimmermann, Melisa Guelhan Inci, Max Liebl, Anett Reisshauer, Julia Toelkes, Harald Groeben, Phil Niggemann, Lutz Kaufner, Julia Klews, Thomas Reinhold, Stephanie Roll, Marlene Lee, Eva Schnura, Jalid Sehouli

Journal: International journal of gynecological cancer : official journal of the International Gynecological Cancer Society 2023;33(8):1304-1309

PMID: 37208019

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Abstract

BACKGROUND

Advanced ovarian cancer is managed by extensive surgery, which could be associated with high morbidity. A personalized pre-habilitation strategy combined with an 'enhanced recovery after surgery' (ERAS) pathway may decrease post-operative morbidity.

PRIMARY OBJECTIVE

To analyze the effects of a combined multi-modal pre-habilitation and ERAS strategy on severe post-operative morbidity for patients with ovarian cancer (primary diagnosis or first recurrence) undergoing cytoreductive surgery.

STUDY HYPOTHESIS

A personalized multi-modal pre-habilitation algorithm entailing a physical fitness intervention, nutritional and psycho-oncological support, completed by an ERAS pathway, reduces post-operative morbidity.

TRIAL DESIGN

This is a prospective, controlled, non-randomized, open, interventional two-center clinical study. Endpoints will be compared with a three-fold control: (a) historic control group (data from institutional ovarian cancer databases); (b) prospective control group (assessed before implementing the intervention); and (c) matched health insurance controls.

INCLUSION CRITERIA

Patients with ovarian, fallopian, or primary peritoneal cancer undergoing primary surgical treatment (primary ovarian cancer or first recurrence) can be included. The intervention group receives an additional multi-level study treatment: (1) standardized frailty assessment followed by (2) a personalized tri-modal pre-habilitation program and (3) peri-operative care according to an ERAS pathway.

EXCLUSION CRITERIA

Inoperable disease or neoadjuvant chemotherapy, simultaneous diagnosis of simultaneous primary tumors, in case of interference with the overall prognosis (except for breast cancer); dementia or other conditions that impair compliance or prognosis.

PRIMARY ENDPOINT

Reduction of severe post-operative complications (according to Clavien- Dindo Classification (CDC) III-V) within 30 days after surgery.

SAMPLE SIZE

Intervention group (n=414, of which approximately 20% insure with the participating health insurance); historic control group (n=198); prospective control group (n=50), health insurance controls (for those intervention patients who are members of the participating health insurance).

ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS

The intervention phase started in December 2021 and will continue until June 2023. As of March 2023, 280 patients have been enrolled in the intervention group. The expected completion of the entire study is September 2024.

TRIAL REGISTRATION

NCT05256576.

Address: Department of Gynecology with Center for Oncological Surgery, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Charité Comprehensive Cancer Center, Berlin, Germany [email protected].; Department of Gynecology with Center for Oncological Surgery, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Charité Comprehensive Cancer Center, Berlin, Germany.; Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte Evangelische Huyssens-Stiftung/Knappschaft GmbH Klinik fur Gynakologie & Gynakologische Onkologie, Essen, Germany.; Institute of Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Charité Comprehensive Cancer Center, Berlin, Germany.; Business Division - Nursing Science, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.; Department of Anesthesiology, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.; Department of Anaesthesia, Critical Care Medicine and Pain Therapy, Kliniken Essen-Mitte Evangelische Huyssens-Stiftung/Knappschaft GmbH, Essen, Germany.; Department of Physical Medicine, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.; Akkon University of Humanities, Berlin, Germany.; Nutrition and Diabetes advisor (DDG) and Dietitian for parental nutrition therapy (VDD), Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.; Nutrition and Diabetes advisor (DDG) and Dietitian for parental nutrition therapy (VDD), Kliniken Essen-Mitte Evangelische Huyssens-Stiftung/Knappschaft GmbH, Essen, Germany.; Department of Ergo-, Logo-, and Physiotherapy, Kliniken Essen-Mitte Evangelische Huyssens-Stiftung/Knappschaft GmbH, Essen, Germany.; Institute for Clinical Pharmacology and Toxicology, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.; Department of Psychosomatic Medicine and Psychotherapy, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Charité Comprehensive Cancer Center, Berlin, Germany.; Fachbereich Versorgungsmanagement, Techniker Krankenkasse, Hamburg, Germany.; Eierstockkrebs Schwerpunkt, Verein Gynäkologische Krebserkrankungen Deutschland e.V, Neumünster, Germany.; Academic Department of Gynecology, Gynecologic Oncology and Obstetrics, Bielefeld University, Medical School and University Medical Center East Westphalia-Lippe, Klinikum Lippe, Detmold, Germany.

DOI: 10.1136/ijgc-2023-004531

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https://antibodies.cancer.gov/detail/CPTC-HLA-B-1

MeSH Terms: Humans, Female, Prospective Studies, Ovarian Neoplasms, Carcinoma, Ovarian Epithelial, Postoperative Complications, Perioperative Care