Fatigue, Malnutrition, Muscle Wasting, Ovarian Cancer
Conditions
Brief summary
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: * Weeks 1-18: approximately 15-30 minutes of daily exercise (cardio, resistance, and balance exercises); nutritional counseling focusing on malnutrition (protein-energy malnutrition). * Weeks 19-25: More intense daily training; nutritional counseling focusing on the Mediterranean diet. The study design includes 3 survey time points: * Baseline: After surgery and before starting chemotherapy * T1: After chemotherapy (week 19) * T2: After intervention (week 26) The primary outcome is: • 6-minute walk test, 6 months after enrollment (T2)
Interventions
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.
Sponsors
Charite University, Berlin, Germany
University Hospital Dresden
Kliniken Essen-Mitte
University Hospital Tuebingen
University Hospital Schleswig-Holstein
Technical University of Munich
Universitätsklinikum Hamburg-Eppendorf
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with FIGO II-IV stage ovarian, fallopian tube, or peritoneal carcinoma * Patients must be treated with surgery and chemotherapy * Patients receiving adjuvant or neoadjuvant chemotherapy but not yet started
Exclusion criteria
* Patients with an Eastern Cooperative Oncology Group (ECOG) performance status greater than 2 * Patients with inadequate German language skills * Patients with physical or mental impairments that make it impossible to perform the training programs or study procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6 Minute Walk Test (distance in metre) | Change in the total distance from T2 (6 months after enrollment) to baseline as target | Sub-maximal exercise test used to assess aerobic capacity and endurance |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Global physical activity questionnaire (GPAQ) | Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26)) | Physical activity in minutes per day, MET minutes per week |
| Assessment of body composition using bioelectrical impedance analysis (BIA) | Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26)) | 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. |
| Grip force dynamometer | Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26)) | Hand gripping force (kg) |
| Polyneuropathy; item derived from EORTC CIPN20 (Item 9) | Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26)) | Problems standing or walking, because can't longer feel the ground under feet |
| Patient Health Questionnaire-9 (PHQ-9) | Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26)) | Depression screening |
| Generalized Anxiety Disorder using GAD-2 | Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26)) | Anxiety |
| 6 Minute Walk Test (distance in metre) | Change in the total distance from T1 (end of chemotherapy, approx. week 18-19) to baseline as target | Sub-maximal exercise test used to assess aerobic capacity and endurance |
| EORTC QLQ-C30 | Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26)) | Quality of life (multidimensional) across 10 subscales |
| EORTC OV-28 | Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26)) | Quality of life (multidimensional) focusing on ovarian cancer across 7 subscales |
| EORT FA-12 | Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26)) | Quality of life (multidimensional) focusing on fatigue |
| Nutritional Risk Screening (NRS 2002) | Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26)) | Malnutrition risk |
| Brief Social Support Scale (BS6) | Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26)) | Social support (tangible support, emotional-informational support) |
| Patient Activation Measure (PAM-13) | Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26)) | Patient Activation Measure |
| Adherence to a Mediterranean diet (MEDAS) | Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26)) | Adherence to a Mediterranean diet is assessed using the 14-item Mediterranean Diet Adherence Screener (MEDAS). |
Countries
Germany
Contacts
Primary ContactHolger Schulz, Prof. Dr.
Backup ContactTabea Maurer, Dr.
Outcome results
None listed