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| Name | Class |
|---|---|
| Charite University, Berlin, Germany | OTHER |
| University Hospital Dresden | OTHER |
| Kliniken Essen-Mitte | OTHER |
| University Hospital Tuebingen |
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The objective of this multicenter randomized controlled trial is to compare a 6-month exercise and nutrition intervention (intervention group, IG) aimed at maintaining or improving physical functioning and quality of life with usual care (control group, CG) in ovarian cancer patients.
The main question it aims to answer is:
• Can an exercise and nutrition program improve physical performance during and after active treatment for ovarian cancer?
Participants of the IG will undergo:
The study design includes 3 survey time points:
The primary outcome is:
• 6-minute walk test, 6 months after enrollment (T2)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | usual care | |
| Intervention | Experimental | 6 month exercise and nutrition intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| combined exercise and nutrition intervention | Behavioral | Patients will be instructed on how to use the Physitrack app. At the start of chemotherapy, patients will be contacted by physiotherapists and dietitians from the University Medical Center Hamburg-Eppendorf either via video call using the app or by phone to discuss the first week's program. Patients can either complete the exercise program at home using the app or receive printed exercise plans in the mail to be completed with the physical therapist of their choice. The exercise program is adjusted weekly until week 9. After week 10, adjustments are made every two weeks. For each program, patients receive a 30-minute counseling session to discuss the exercises. The 30-minute nutritional counseling session occurs every two weeks. For patients receiving neoadjuvant chemotherapy, the exercise program is interrupted for the time of surgery and the two-week recovery period and resumed when chemotherapy is resumed. |
| Measure | Description | Time Frame |
|---|---|---|
| 6 Minute Walk Test (distance in metre) | Sub-maximal exercise test used to assess aerobic capacity and endurance | Change in the total distance from T2 (6 months after enrollment) to baseline as target |
| Measure | Description | Time Frame |
|---|---|---|
| 6 Minute Walk Test (distance in metre) | Sub-maximal exercise test used to assess aerobic capacity and endurance | Change in the total distance from T1 (end of chemotherapy, approx. week 18-19) to baseline as target |
| Global physical activity questionnaire (GPAQ) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Holger Schulz, Prof. Dr. | Contact | +49 (0) 40 7410 56806 | schulz@uke.de | |
| Tabea Maurer, Dr. | Contact | +49 (0) 40 7410 50800 | ta.maurer@uke.de |
| Name | Affiliation | Role |
|---|---|---|
| Holger Schulz, Prof. Dr. | Universitätsklinikum Hamburg-Eppendorf | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité Universitätsmedizin Berlin | Recruiting | Berlin | 13353 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39528997 | Derived | Maurer T, Belau MH, Zyriax BC, Welsch G, Jagemann B, Chang-Claude J, Daubmann A, Buchholz A, Glismann K, Moeller A, Sehouli J, Woopen H, Wimberger P, Harter P, Kaiser S, Maass N, Kiechle M, Engler T, Schmalfeldt B, Schulz H. Study protocol of an exercise and nutrition intervention for ovarian cancer patients during and after first-line chemotherapy (BENITA) - a randomized controlled trial. BMC Cancer. 2024 Nov 11;24(1):1379. doi: 10.1186/s12885-024-13102-y. |
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The study protocol will be published in a peer-reviewed journal at the outset. The Statistical Analysis Plan (SAP), Informed Consent Form (ICF), and analysis code will be provided upon request, if available at the time of request.
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D044342 | Malnutrition |
| D009133 | Muscular Atrophy |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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| OTHER |
| University Hospital Schleswig-Holstein | OTHER |
| Technical University of Munich | OTHER |
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|
Physical activity in minutes per day, MET minutes per week |
| Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26)) |
| Assessment of body composition using bioelectrical impedance analysis (BIA) | Bioelectrical impedance analyzers use an alternating electric current to measure the two components of bioelectrical impedance in the human body, resistance r and reactance Xc. In electrophysiological terms, resistance (per unit volume) correlates negatively with the amount of body fluid (body water and fat-free mass (FFM)) through which the current flows, while reactance correlates positively with the mass of body cells. The magnitude of Xc in relation to R is expressed as the phase angle (PA). From the measured R and Xc values and other subject data, additional indicators of body composition (e.g., total body water, fat-free mass, and fat mass) can be estimated using specific prediction equations based on modeling assumptions that are generally population-, age-, sex-, fat-, and disease-specific. | Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26)) |
| Grip force dynamometer | Hand gripping force (kg) | Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26)) |
| Polyneuropathy; item derived from EORTC CIPN20 (Item 9) | Problems standing or walking, because can't longer feel the ground under feet | Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26)) |
| Patient Health Questionnaire-9 (PHQ-9) | Depression screening | Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26)) |
| Generalized Anxiety Disorder using GAD-2 | Anxiety | Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26)) |
| Adherence to a Mediterranean diet (MEDAS) | Adherence to a Mediterranean diet is assessed using the 14-item Mediterranean Diet Adherence Screener (MEDAS). | Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26)) |
| EORTC QLQ-C30 | Quality of life (multidimensional) across 10 subscales | Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26)) |
| EORTC OV-28 | Quality of life (multidimensional) focusing on ovarian cancer across 7 subscales | Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26)) |
| EORT FA-12 | Quality of life (multidimensional) focusing on fatigue | Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26)) |
| Nutritional Risk Screening (NRS 2002) | Malnutrition risk | Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26)) |
| Brief Social Support Scale (BS6) | Social support (tangible support, emotional-informational support) | Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26)) |
| Patient Activation Measure (PAM-13) | Patient Activation Measure | Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26)) |
| Universitätskrebszentrum Dresden | Not yet recruiting | Dresden | 01307 | Germany |
|
| Evang. Klinik Essen-Mitte | Recruiting | Essen | 45136 | Germany |
|
| Universitätsklinikum Hamburg-Eppendorf | Recruiting | Hamburg | 20246 | Germany |
|
| Universitätsklinikum Schleswig-Holstein | Not yet recruiting | Kiel | 24105 | Germany |
|
| Klinikum rechts der Isar der Technischen Universität München Ismaniger Straße 22 | Not yet recruiting | München | 81675 | Germany |
|
| Universitätsklinikum Tübingen | Not yet recruiting | Tübingen | 72076 | Germany |
|
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |