Exercise and Nutrition Intervention in Ovarian Cancer

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

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.

Sponsors & Collaborators

• Charite University, Berlin, Germany

  collaborator OTHER

• University Hospital Dresden

  collaborator OTHER

• Kliniken Essen-Mitte

  collaborator OTHER

• University Hospital Tuebingen

  collaborator OTHER

• University Hospital Schleswig-Holstein

  collaborator OTHER

• Technical University of Munich

  collaborator OTHER

• Universitätsklinikum Hamburg-Eppendorf

  lead OTHER

Principal Investigators

• Holger Schulz, Prof. Dr. · Universitätsklinikum Hamburg-Eppendorf

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-01-10

Primary Completion

2025-07-31

Completion

2025-12-31

Countries

• Germany

Study Locations