Study protocol of an exercise and nutrition intervention for ovarian cancer patients during and after first-line chemotherapy (BENITA) - a randomized controlled trial.

Autor: Maurer T; Center for Psychosocial Medicine, Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. ta.maurer@uke.de., Belau MH; Institute of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany., Zyriax BC; Midwifery Science-Health Care Research and Prevention, Research Group Preventive Medicine and Nutrition, Institute for Health Service Research in Dermatology and Nursing (IVDP), University Medical Center Hamburg-Eppendorf, Hamburg, Germany., Welsch G; Orthopedic Sports Medicine, Department of Trauma and Orthopedic Surgery, UKE Athleticum, University Medical Center Hamburg-Eppendorf, Hamburg, Germany., Jagemann B; Midwifery Science-Health Care Research and Prevention, Research Group Preventive Medicine and Nutrition, Institute for Health Service Research in Dermatology and Nursing (IVDP), University Medical Center Hamburg-Eppendorf, Hamburg, Germany., Chang-Claude J; Division of Cancer Epidemiology, German Cancer Research Center (DKFZ)University Medical Centre Hamburg-Eppendorf, University Cancer Centre Hamburg (UCCH), Heidelberg, Germany., Daubmann A; Institute of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany., Buchholz A; Institute of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany., Glismann K; Orthopedic Sports Medicine, Department of Trauma and Orthopedic Surgery, UKE Athleticum, University Medical Center Hamburg-Eppendorf, Hamburg, Germany., Moeller A; Orthopedic Sports Medicine, Department of Trauma and Orthopedic Surgery, UKE Athleticum, University Medical Center Hamburg-Eppendorf, Hamburg, Germany., Sehouli J; Department of Gynecology with Center for Oncological Surgery, Charite Comprehensive Cancer Center, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt- Universität zu Berlin, Berlin, Germany., Woopen H; Department of Gynecology with Center for Oncological Surgery, Charite Comprehensive Cancer Center, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt- Universität zu Berlin, Berlin, Germany., Wimberger P; National Center for Tumor Diseases Dresden, Department of Gynecology and Obstetrics, University Hospital Dresden, TU Dresden, Dresden, Germany., Harter P; Department of Gynecology & Gynecologic Oncology, Ev. Kliniken Essen-Mitte, Essen, Germany., Kaiser S; Department of Gynecology & Gynecologic Oncology, Ev. Kliniken Essen-Mitte, Essen, Germany., Maass N; Department of Gynecology and Obstetrics, University Hospital of Schleswig-Holstein, Campus Kiel, Kiel, Germany., Kiechle M; Department of Gynecology and Obstetrics, University Hospital Rechts der Isar, Technical University Munich (TU), Munich, Germany., Engler T; Department of Women's Health, Tübingen University Hospital, Tübingen, Germany., Schmalfeldt B; Department of Gynecology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany., Schulz H; Center for Psychosocial Medicine, Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Jazyk: angličtina
Zdroj: BMC cancer [BMC Cancer] 2024 Nov 11; Vol. 24 (1), pp. 1379. Date of Electronic Publication: 2024 Nov 11.
DOI: 10.1186/s12885-024-13102-y
Abstrakt: Background: In ovarian cancer frequently reported side effects are muscle wasting and malnutrition, leading to frailty, decreased health-related quality of life (HRQoL), and cancer-related fatigue (CRF). Both often begin during first-line chemotherapy and develop progressively into a refractory state, if left untreated.
Method: Primary objective is to evaluate effectiveness of a newly developed app-based exercise and nutrition program under non-standardized conditions of clinical routine. We hypothize that patients who receive an individually tailored exercise and nutrition program for six months will have improved physical performance compared to patients who receive usual care. This is a multicenter randomized controlled open-label trial comparing an intervention group receiving a six-month exercise and nutrition intervention and a control group receiving usual care. Primary endpoint is the change in 6-Minute Walk Test (6MWT) from baseline to T2 (26 weeks after baseline) as a measure of physical functioning. Secondary endpoints include patients' utilization and adherence to the nutrition program (MEDAS), their malnutrition risk (NRS2002), as well as patients' HRQoL (see Table 1). Using the two-sample t-test with a two-sided type I error of 5% and 80% power, a medium effect size of Cohen's d = 0.50 can be demonstrated with a minimum of 128 participants (64 per group). With a conservatively estimated dropout rate of 30%, 182 patients will be recruited. Patients who are included must be over 18 years of age, be diagnosed with ovarian cancer, cancer of fallopian tubes, or peritoneal cancer, FIGO stages II-IV, receive surgery and chemotherapy (adjuvant or neoadjuvant). Exclusion criteria are an ECOG status greater than 2, inadequate proficiency in German, or physical or mental impairments hindering the implementation of the program or execution of study procedures.
Discussion: In case of success, the project contributes in the long term to (i) improving medical care (diagnosis, psychoeducation, patient orientation, and empowerment), (ii) reducing the burden of disease and promoting physical autonomy for patients, and (iii) being incorporated into relevant guidelines.
Trial Registration: The study was registered at ClinicalTrials.gov (NCT06250686).
Competing Interests: Declarations Ethics approval and consent to participate The study is conducted in accordance with the Declaration of Helsinki, and the protocol was approved by the Ethics Committee of the Hamburg Medical Association (2023-101090-BO-ff). All participants gave informed consent. Consent for publication Not applicable. Competing interests The authors declare no competing interests.
(© 2024. The Author(s).)
Databáze: MEDLINE
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