Study protocol of an exercise and nutrition intervention for ovarian cancer patients during and after first-line chemotherapy (BENITA) - a randomized controlled trial
Tabea Maurer,
M. H. Belau,
B-C. Zyriax,
G. Welsch,
B. Jagemann,
J. Chang-Claude,
A. Daubmann,
A. Buchholz,
K. Glismann,
A. Moeller,
J. Sehouli,
H. Woopen,
P. Wimberger,
P. Harter,
S. Kaiser,
N. Maass,
M. Kiechle,
T. Engler,
B. Schmalfeldt,
H. Schulz
Affiliations
Tabea Maurer
Center for Psychosocial Medicine, Department of Medical Psychology, University Medical Center Hamburg-Eppendorf
M. H. Belau
Institute of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf
B-C. Zyriax
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
G. Welsch
Orthopedic Sports Medicine, Department of Trauma and Orthopedic Surgery, UKE Athleticum, University Medical Center Hamburg-Eppendorf
B. Jagemann
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
J. Chang-Claude
Division of Cancer Epidemiology, German Cancer Research Center (DKFZ)University Medical Centre Hamburg-Eppendorf, University Cancer Centre Hamburg (UCCH)
A. Daubmann
Institute of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf
A. Buchholz
Institute of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf
K. Glismann
Orthopedic Sports Medicine, Department of Trauma and Orthopedic Surgery, UKE Athleticum, University Medical Center Hamburg-Eppendorf
A. Moeller
Orthopedic Sports Medicine, Department of Trauma and Orthopedic Surgery, UKE Athleticum, University Medical Center Hamburg-Eppendorf
J. Sehouli
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
H. Woopen
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
P. Wimberger
National Center for Tumor Diseases Dresden, Department of Gynecology and Obstetrics, University Hospital Dresden, TU Dresden
P. Harter
Department of Gynecology & Gynecologic Oncology, Ev. Kliniken Essen-Mitte
S. Kaiser
Department of Gynecology & Gynecologic Oncology, Ev. Kliniken Essen-Mitte
N. Maass
Department of Gynecology and Obstetrics, University Hospital of Schleswig-Holstein
M. Kiechle
Department of Gynecology and Obstetrics, University Hospital Rechts der Isar, Technical University Munich (TU)
T. Engler
Department of Women’s Health, Tübingen University Hospital
B. Schmalfeldt
Department of Gynecology, University Medical Center Hamburg-Eppendorf
H. Schulz
Center for Psychosocial Medicine, Department of Medical Psychology, University Medical Center Hamburg-Eppendorf
Abstract 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).
