Impact of FRAilty screening and Geriatric assessment and INtervention in older patients with epithelial Ovarian Cancer: A multicenter randomized clinical trial protocol (FRAGINOC).

Autor: Daviu Cobián C; Department of Gynecology and Obstetrics, Zealand University Hospital, Roskilde, Denmark; Department of Gynecology and Obstetrics, Odense University Hospital, Denmark. Electronic address: mdav@regionsjaelland.dk., Oreskov JO; Department of Gynecology, Rigshospitalet, Copenhagen University Hospital, Denmark., Blaakaer J; Department of Gynecology and Obstetrics, Odense University Hospital, Denmark; Department of Clinical Research, University of Southern Denmark, Denmark; Academy of Geriatric Cancer Research (AgeCare), Odense University Hospital, Denmark., Jespersen E; Department of Clinical Research, University of Southern Denmark, Denmark; Department of Oncology, Odense University Hospital, Denmark., Jørgensen TL; Department of Clinical Research, University of Southern Denmark, Denmark; Academy of Geriatric Cancer Research (AgeCare), Odense University Hospital, Denmark; Department of Oncology, Odense University Hospital, Denmark., Ryg J; Department of Clinical Research, University of Southern Denmark, Denmark; Academy of Geriatric Cancer Research (AgeCare), Odense University Hospital, Denmark; Department of Geriatric Medicine, Odense University Hospital, Denmark., Herrstedt J; Department of Clinical Oncology and Palliative Care, Zealand University Hospital, Roskilde, Denmark., Høgdall C; Department of Gynecology, Rigshospitalet, Copenhagen University Hospital, Denmark., Lund CM; Department of Medicine, Herlev and Gentofte hospital, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, Copenhagen University, Denmark., Seibæk L; Department of Gynecology and Obstetrics, Aarhus University Hospital, Aarhus, Denmark., Vinther A; Department of Physiotherapy and Occupational Therapy, Copenhagen University Hospital, Herlev and Gentofte Hospital, Herlev, Denmark; Hospital Secretariat and Communications, Research, Copenhagen University Hospital, Herlev and Gentofte Hospital, Herlev, Denmark., Ekmann-Gade AW; Department of Obstetrics and Gynecology, Herlev University Hospital, Herlev, Denmark., Schnack TH; Department of Gynecology and Obstetrics, Odense University Hospital, Denmark; Department of Clinical Research, University of Southern Denmark, Denmark.
Jazyk: angličtina
Zdroj: Journal of geriatric oncology [J Geriatr Oncol] 2024 Apr; Vol. 15 (3), pp. 101713. Date of Electronic Publication: 2024 Feb 06.
DOI: 10.1016/j.jgo.2024.101713
Abstrakt: Introduction: Radical surgery combined with chemotherapy is the only potential curative treatment of patients with advanced epithelial ovarian cancer (EOC). However, 43% of older Danish patients with EOC are not referred to surgery due to frailty, age, or fear of complications. Comprehensive geriatric assessment (CGA) has demonstrated ability to reduce frailty in older patients, but there is a knowledge gap regarding its effect before or during treatment in older adults with EOC. This protocol presents a randomized controlled trial (RCT), which evaluates the effect of CGA-based interventions including individualized physical exercise therapy in older adults with EOC during neoadjuvant chemotherapy (NACT).
Materials and Methods: This RCT will include patients aged ≥70 years with primary EOC referred to NACT. Patients will be randomized 1:1 to intervention or standard of care, along with neoadjuvant antineoplastic treatment. Stratification for performance status and center of inclusion will be performed. In the intervention arm, a geriatrician will perform CGA and corresponding geriatric interventions and patients will undergo an individualized home-based exercise program managed by a physiotherapist. All patients will be evaluated with Geriatric-8, modified Geriatric-8, clinical frailty scale, and physical tests at randomization. Predictive values (positive/negative) will be evaluated for CGA detected impairments. The primary endpoint is the proportion of patients referred to interval debulking surgery (IDS). Secondary endpoints include the proportion who complete oncological treatment, improvements in physical tests, quality of life measured by European Organization for Research and Treatment of Cancer-Quality of Life questionnaires at inclusion, after three cycles of chemotherapy, and at end of chemotherapy treatment. Furthermore, the association between results of geriatric screening tests, CGA, and physical tests with complication rate and progression free survival will be examined. The primary outcome will be analyzed with logistic regression in the intention-to-treat population. Power calculations reveal the need to enroll 216 patients.
Discussion: The present study examines whether CGA-based interventions including individualized physical exercise can increase the referral rate for potential curative IDS in older patients with EOC. If successful, this will result in more patients undergoing surgery and completing chemotherapy, preventing complications, and ultimately improving quality of life and survival. The study setup may establish the basis for direct clinical implementation if proven effective.
Competing Interests: Declaration of competing interest The authors declare that they have no competing interests.
(Copyright © 2024 Elsevier Ltd. All rights reserved.)
Databáze: MEDLINE
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