NCT06250686

Exercise and Nutrition Intervention in Ovarian Cancer

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 185 (estimated)
• Sponsor: Universitätsklinikum Hamburg-Eppendorf · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	combined exercise and nutrition intervention	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.

Timeline

• Start date: 2024-01-10
• Primary completion: 2025-07-31
• Completion: 2025-12-31
• First posted: 2024-02-09
• Last updated: 2024-02-09

Locations

7 sites across 1 country: Germany