Exercise and Nutrition Intervention in Ovarian Cancer

Ovarian Cancer Clinical Trial

— BENITA  

Official title:

Exercise and Nutrition Intervention in Ovarian Cancer - Development of a Care Concept and Evaluation in Routine Clinical Practice

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06250686
• Other study ID #: BENITA
• Status: Recruiting
• Phase: N/A
• Start date: January 10, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: Holger Schulz, Prof. Dr.
• Phone: +49 (0) 40 7410 56806
• Email: schulz[@]uke.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 185
• Est. completion date: December 31, 2025
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Fatigue
• Malnutrition
• Muscle Wasting
• Muscular Atrophy
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Behavioral:
• combined exercise and nutrition intervention
Patients will be instructed on how to use the Physitrack app. At the start of chemotherapy, patients will be contacted by physiotherapists and dietitians from the University Medical Center Hamburg-Eppendorf either via video call using the app or by phone to discuss the first week's program. Patients can either complete the exercise program at home using the app or receive printed exercise plans in the mail to be completed with the physical therapist of their choice. The exercise program is adjusted weekly until week 9. After week 10, adjustments are made every two weeks. For each program, patients receive a 30-minute counseling session to discuss the exercises. The 30-minute nutritional counseling session occurs every two weeks. For patients receiving neoadjuvant chemotherapy, the exercise program is interrupted for the time of surgery and the two-week recovery period and resumed when chemotherapy is resumed.

Locations

Country	Name	City	State
Germany	Charité Universitätsmedizin Berlin	Berlin
Germany	Universitätskrebszentrum Dresden	Dresden
Germany	Evang. Klinik Essen-Mitte	Essen
Germany	Universitätsklinikum Hamburg-Eppendorf	Hamburg
Germany	Universitätsklinikum Schleswig-Holstein	Kiel
Germany	Klinikum rechts der Isar der Technischen Universität München Ismaniger Straße 22	München
Germany	Universitätsklinikum Tübingen	Tübingen

Sponsors (7)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf	Charite University, Berlin, Germany, Kliniken Essen-Mitte, Technical University of Munich, University Hospital Dresden, University Hospital Schleswig-Holstein, University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6 Minute Walk Test (distance in metre)	Sub-maximal exercise test used to assess aerobic capacity and endurance	Change in the total distance from T2 (6 months after enrollment) to baseline as target
Secondary	6 Minute Walk Test (distance in metre)	Sub-maximal exercise test used to assess aerobic capacity and endurance	Change in the total distance from T1 (end of chemotherapy, approx. week 18-19) to baseline as target
Secondary	Global physical activity questionnaire (GPAQ)	Physical activity in minutes per day, MET minutes per week	Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))
Secondary	Assessment of body composition using bioelectrical impedance analysis (BIA)	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.	Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))
Secondary	Grip force dynamometer	Hand gripping force (kg)	Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))
Secondary	Polyneuropathy; item derived from EORTC CIPN20 (Item 9)	Problems standing or walking, because can't longer feel the ground under feet	Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))
Secondary	Patient Health Questionnaire-9 (PHQ-9)	Depression screening	Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))
Secondary	Generalized Anxiety Disorder using GAD-2	Anxiety	Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))
Secondary	Adherence to a Mediterranean diet (MEDAS)	Adherence to a Mediterranean diet is assessed using the 14-item Mediterranean Diet Adherence Screener (MEDAS).	Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))
Secondary	EORTC QLQ-C30	Quality of life (multidimensional) across 10 subscales	Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))
Secondary	EORTC OV-28	Quality of life (multidimensional) focusing on ovarian cancer across 7 subscales	Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))
Secondary	EORT FA-12	Quality of life (multidimensional) focusing on fatigue	Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))
Secondary	Nutritional Risk Screening (NRS 2002)	Malnutrition risk	Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))
Secondary	Brief Social Support Scale (BS6)	Social support (tangible support, emotional-informational support)	Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))
Secondary	Patient Activation Measure (PAM-13)	Patient Activation Measure	Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))