Exercise and Nutrition Intervention in Ovarian Cancer (BENITA)

Universitätsklinikum Hamburg-Eppendorf

Status

Enrolling

Conditions

Malnutrition

Fatigue

Ovarian Cancer

Muscle Wasting

Treatments

Behavioral: combined exercise and nutrition intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT06250686

BENITA

Details and patient eligibility

About

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)

Enrollment

185 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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