Exercise and Nutrition Intervention in Ovarian Cancer (BENITA)

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

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)

Study Overview

• Status: Recruiting
• Conditions: Fatigue; Malnutrition; Ovarian Cancer; Muscle Wasting
• Intervention / Treatment: Behavioral: combined exercise and nutrition intervention

• Study Type: Interventional
• Enrollment (Estimated): 185
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Holger Schulz, Prof. Dr.; Phone Number: +49 (0) 40 7410 56806; Email: schulz@uke.de
• Study Contact Backup: Name: Tabea Maurer, Dr.; Phone Number: +49 (0) 40 7410 50800; Email: ta.maurer@uke.de

Study Locations

• Germany
  • Berlin, Germany, 13353
    • Recruiting
    • Charite Universitatsmedizin Berlin
    • Principal Investigator: Jalid Sehouli, Prof. Dr.
    • Contact: Jalid Sehouli, Prof. Dr.
  • Dresden, Germany, 01307
    • Not yet recruiting
    • Universitätskrebszentrum Dresden
    • Principal Investigator: Pauline Wimberger, Prof. Dr.
    • Contact: Pauline Wimberger, Prof. Dr.
  • Essen, Germany, 45136
    • Recruiting
    • Evang. Klinik Essen-Mitte
    • Contact: Philipp Harter, PD Dr.
    • Principal Investigator: Philipp Harter, PD Dr.
  • Hamburg, Germany, 20246
    • Recruiting
    • Universitätsklinikum Hamburg-Eppendorf
    • Contact: Barbara Schmalfeldt, Prof. Dr.
    • Sub-Investigator: Barbara Schmalfeldt, Prof. Dr.
  • Kiel, Germany, 24105
    • Not yet recruiting
    • Universitätsklinikum Schleswig-Holstein
    • Contact: Nicolai Maass, Prof. Dr.
    • Principal Investigator: Nicolai Maass, Prof. Dr.
  • München, Germany, 81675
    • Not yet recruiting
    • Klinikum rechts der Isar der Technischen Universität München Ismaniger Straße 22
    • Contact: Marion Kiechle, Prof. Dr.
    • Principal Investigator: Marion Kiechle, Prof. Dr.
  • Tübingen, Germany, 72076
    • Not yet recruiting
    • Universitatsklinikum Tubingen
    • Contact: Stefan Kommoss, Prof. Dr.
    • Principal Investigator: Stefan Kommoss, Prof. Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; usual care
Experimental: Intervention; 6 month exercise and nutrition 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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))
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))
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))
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))
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))
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))
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))
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))
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))
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))
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))
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))
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))

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Collaborators: Charite University, Berlin, Germany; University Hospital Tuebingen; Technical University of Munich; University Hospital Schleswig-Holstein; Kliniken Essen-Mitte; University Hospital Dresden
• Investigators: Principal Investigator: Holger Schulz, Prof. Dr., Universitätsklinikum Hamburg-Eppendorf

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2024
• Primary Completion (Estimated): July 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: December 4, 2023
• First Submitted That Met QC Criteria: February 7, 2024
• First Posted (Estimated): February 9, 2024

Study Record Updates

• Last Update Posted (Estimated): February 9, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Neurologic Manifestations; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Nutrition Disorders; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Atrophy; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Ovarian Neoplasms; Muscular Atrophy; Carcinoma, Ovarian Epithelial; Malnutrition
• Other Study ID Numbers: BENITA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The study protocol will be published in a peer-reviewed journal at the outset. The Statistical Analysis Plan (SAP), Informed Consent Form (ICF), and analysis code will be provided upon request, if available at the time of request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No