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Exercise and Nutrition Intervention in Ovarian Cancer - Development of a Care Concept and Evaluation in Routine Clinical Practice
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)
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
Charité Universitätsmedizin Berlin
Berlin, Germany
Universitätskrebszentrum Dresden
Dresden, Germany
Evang. Klinik Essen-Mitte
Essen, Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany
Universitätsklinikum Schleswig-Holstein
Kiel, Germany
Klinikum rechts der Isar der Technischen Universität München Ismaniger Straße 22
München, Germany
Universitätsklinikum Tübingen
Tübingen, Germany
Start Date
January 10, 2024
Primary Completion Date
July 31, 2025
Completion Date
December 31, 2025
Last Updated
February 9, 2024
185
ESTIMATED participants
combined exercise and nutrition intervention
BEHAVIORAL
Lead Sponsor
Universitätsklinikum Hamburg-Eppendorf
Collaborators
NCT04550494
NCT05039801
Data Source & Attribution
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