Interventional Recruiting
NCT06250686 on ClinicalTrials.gov
Exercise and Nutrition Intervention in Ovarian Cancer
Official title: Exercise and Nutrition Intervention in Ovarian Cancer - Development of a Care Concept and Evaluation in Routine Clinical Practice
- Sponsor: University Medical Center Hamburg-Eppendorf
- Collaborators: Charite University, Berlin, Germany, University Hospital Dresden, Kliniken Essen-Mitte, University Hospital Tuebingen, University Hospital Schleswig-Holstein, Technical University of Munich
- Enrollment: 185 (Estimated)
- Study start: 2024-01-10 (Actual)
- Primary completion: 2025-07-31 (Estimated)
- Study completion: 2025-12-31 (Estimated)
- Allocation: Randomized
- InterventionModel: Parallel
- Masking: Double (Investigator, Outcomes Assessor)
- PrimaryPurpose: Supportive Care
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)
Conditions
- Ovarian Cancer
- Malnutrition
- Muscle Wasting
- Fatigue
Intervention / Treatment
- Behavioral: combined exercise and nutrition intervention
Primary Outcome Measures
-
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
Countries
Germany
Locations and Investigators
-
Charité Universitätsmedizin Berlin, Berlin, Germany (Recruiting)
- Jalid Sehouli, Prof. Dr.
- Jalid Sehouli, Prof. Dr. (Principal Investigator)
-
Universitätskrebszentrum Dresden, Dresden, Germany (Not yet recruiting)
- Pauline Wimberger, Prof. Dr.
- Pauline Wimberger, Prof. Dr. (Principal Investigator)
-
Evang. Klinik Essen-Mitte, Essen, Germany (Recruiting)
- Philipp Harter, PD Dr.
- Philipp Harter, PD Dr. (Principal Investigator)
-
Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany (Recruiting)
- Barbara Schmalfeldt, Prof. Dr.
- Barbara Schmalfeldt, Prof. Dr.
-
Universitätsklinikum Schleswig-Holstein, Kiel, Germany (Not yet recruiting)
- Nicolai Maass, Prof. Dr.
- Nicolai Maass, Prof. Dr. (Principal Investigator)
-
Klinikum rechts der Isar der Technischen Universität München Ismaniger Straße 22, München, Germany (Not yet recruiting)
- Marion Kiechle, Prof. Dr.
- Marion Kiechle, Prof. Dr. (Principal Investigator)
-
Universitätsklinikum Tübingen, Tübingen, Germany (Not yet recruiting)
- Stefan Kommoss, Prof. Dr.
- Stefan Kommoss, Prof. Dr. (Principal Investigator)
Study Officials
- Holger Schulz, Prof. Dr. (Principal Investigator) — Universitätsklinikum Hamburg-Eppendorf