Exercise and Nutrition Intervention in Ovarian Cancer

Not Applicable

Recruiting

• Conditions: Fatigue; Malnutrition; Ovarian Cancer; Muscle Wasting
• Interventions: Behavioral: combined exercise and nutrition intervention

• Registration Number: NCT06250686
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

Brief 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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-04
• Study Start: 2024-01-10
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-07
• Last Update Submitted: 2024-02-07
• Study First Posted: 2024-02-09
• Last Update Posted: 2024-02-09
• Primary Completion: 2025-07-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 185

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	combined exercise and nutrition intervention	6 month exercise and nutrition intervention

Primary Outcome Measures

Name	Time	Method
6 Minute Walk Test (distance in metre)	Change in the total distance from T2 (6 months after enrollment) to baseline as target	Sub-maximal exercise test used to assess aerobic capacity and endurance

Secondary Outcome Measures

Name	Time	Method
6 Minute Walk Test (distance in metre)	Change in the total distance from T1 (end of chemotherapy, approx. week 18-19) to baseline as target	Sub-maximal exercise test used to assess aerobic capacity and endurance
Global physical activity questionnaire (GPAQ)	Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))	Physical activity in minutes per day, MET minutes per week
Patient Health Questionnaire-9 (PHQ-9)	Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))	Depression screening
EORTC OV-28	Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))	Quality of life (multidimensional) focusing on ovarian cancer across 7 subscales
Assessment of body composition using bioelectrical impedance analysis (BIA)	Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))	Bioelectrical impedance analyzers use an alternating electric current to measure the two components of bioelectrical impedance in the human body, resistance r and reactance Xc. In electrophysiological terms, resistance (per unit volume) correlates negatively with the amount of body fluid (body water and fat-free mass (FFM)) through which the current flows, while reactance correlates positively with the mass of body cells. The magnitude of Xc in relation to R is expressed as the phase angle (PA). From the measured R and Xc values and other subject data, additional indicators of body composition (e.g., total body water, fat-free mass, and fat mass) can be estimated using specific prediction equations based on modeling assumptions that are generally population-, age-, sex-, fat-, and disease-specific.
Grip force dynamometer	Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))	Hand gripping force (kg)
Generalized Anxiety Disorder using GAD-2	Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))	Anxiety
Polyneuropathy; item derived from EORTC CIPN20 (Item 9)	Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))	Problems standing or walking, because can't longer feel the ground under feet
Adherence to a Mediterranean diet (MEDAS)	Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))	Adherence to a Mediterranean diet is assessed using the 14-item Mediterranean Diet Adherence Screener (MEDAS).
EORTC QLQ-C30	Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))	Quality of life (multidimensional) across 10 subscales
EORT FA-12	Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))	Quality of life (multidimensional) focusing on fatigue
Nutritional Risk Screening (NRS 2002)	Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))	Malnutrition risk
Brief Social Support Scale (BS6)	Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))	Social support (tangible support, emotional-informational support)
Patient Activation Measure (PAM-13)	Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))	Patient Activation Measure

Trial Locations

Locations (7)

Universitätsklinikum Schleswig-Holstein; 🇩🇪 Kiel, Germany

Klinikum rechts der Isar der Technischen Universität München Ismaniger Straße 22; 🇩🇪 München, Germany

Evang. Klinik Essen-Mitte; 🇩🇪 Essen, Germany

Charité Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany

Universitätsklinikum Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany

Universitätskrebszentrum Dresden; 🇩🇪 Dresden, Germany

Universitätsklinikum Tübingen; 🇩🇪 Tübingen, Germany