Exercise and Nutrition Intervention in Ovarian Cancer

Last updated: February 7, 2024
Sponsor: Universitätsklinikum Hamburg-Eppendorf
Overall Status: Active - Recruiting

Phase

N/A

Condition

Weight Loss

Diet And Nutrition

Ovarian Cancer

Treatment

combined exercise and nutrition intervention

Clinical Study ID

NCT06250686
BENITA
  • Ages > 18
  • Female

Study 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 Criteria

Inclusion

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

Exclusion Criteria:

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

Study Design

Total Participants: 185
Treatment Group(s): 1
Primary Treatment: combined exercise and nutrition intervention
Phase:
Study Start date:
January 10, 2024
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Charité Universitätsmedizin Berlin

    Berlin, 13353
    Germany

    Active - Recruiting

  • Universitätskrebszentrum Dresden

    Dresden, 01307
    Germany

    Site Not Available

  • Evang. Klinik Essen-Mitte

    Essen, 45136
    Germany

    Active - Recruiting

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20246
    Germany

    Active - Recruiting

  • Universitätsklinikum Schleswig-Holstein

    Kiel, 24105
    Germany

    Site Not Available

  • Klinikum rechts der Isar der Technischen Universität München Ismaniger Straße 22

    München, 81675
    Germany

    Site Not Available

  • Universitätsklinikum Tübingen

    Tübingen, 72076
    Germany

    Site Not Available

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