Exercise and Nutrition Intervention in Ovarian Cancer - Development of a Care Concept and Evaluation in Routine Clinical Practice

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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)

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Germany
Charité Universitätsmedizin Berlin
RECRUITING
Berlin
Universitätskrebszentrum Dresden
NOT_YET_RECRUITING
Dresden
Evang. Klinik Essen-Mitte
RECRUITING
Essen
Universitätsklinikum Hamburg-Eppendorf
RECRUITING
Hamburg
Universitätsklinikum Schleswig-Holstein
NOT_YET_RECRUITING
Kiel
Klinikum rechts der Isar der Technischen Universität München Ismaniger Straße 22
NOT_YET_RECRUITING
München
Universitätsklinikum Tübingen
NOT_YET_RECRUITING
Tübingen
Contact Information
Primary
Holger Schulz, Prof. Dr.
schulz@uke.de
+49 (0) 40 7410 56806
Backup
Tabea Maurer, Dr.
ta.maurer@uke.de
+49 (0) 40 7410 50800
Time Frame
Start Date: 2024-01-10
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 185
Treatments
No_intervention: Control group
usual care
Experimental: Intervention
6 month exercise and nutrition intervention
Related Therapeutic Areas
Sponsors
Collaborators: University Hospital Tuebingen, Charite University, Berlin, Germany, University Hospital Dresden, University Hospital Schleswig-Holstein, Technical University of Munich, Kliniken Essen-Mitte
Leads: Universitätsklinikum Hamburg-Eppendorf

This content was sourced from clinicaltrials.gov