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Exercise and Nutrition Intervention in Ovarian Cancer

Exercise and Nutrition Intervention in Ovarian Cancer

Recruiting
18 years and older
Female
Phase N/A

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Overview

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

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 details
    Ovarian Cancer
    Malnutrition
    Muscle Wasting
    Fatigue

NCT06250686

Universitätsklinikum Hamburg-Eppendorf

16 February 2024

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