Exercise and Nutrition Intervention in Ovarian Cancer

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Description

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)

Study Overview

Start Date
January 10, 2024
Completion Date
December 31, 2025
Enrollment
185
Date Posted
February 9, 2024
Accepts Healthy Volunteers?
No
Gender
Female

Locations

Full Address
Charité Universitätsmedizin Berlin
Berlin 13353, Germany

Evang. Klinik Essen-Mitte
Essen 45136, Germany

Universitätsklinikum Hamburg-Eppendorf
Hamburg 20246, Germany

Eligibility

Minimum Age (years)
18
Eligibility Criteria
Inclusion Criteria:

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

Exclusion Criteria:

Patients with an Eastern Cooperative Oncology Group (ECOG) performance status greater than 2
Patients with inadequate German language skills
Patients with physical or mental impairments that make it impossible to perform the training programs or study procedures

Study Contact Info

Study Contact Name
Holger Schulz, Prof. Dr.; Tabea Maurer, Dr.
Study Contact Email

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
NCTid (if applicable)
NCT06250686