Clinical trial NCT06250686: Exercise and Nutrition Intervention in Ovarian Cancer
Official title: Exercise and Nutrition Intervention in Ovarian Cancer - Development of a Care Concept and Evaluation in Routine Clinical Practice
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ovarian Cancer
Malnutrition
Muscle Wasting
Fatigue
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
Collaborators: name: Charite University, Berlin, Germany
name: University Hospital Dresden
name: Kliniken Essen-Mitte
name: University Hospital Tuebingen
name: University Hospital Schleswig-Holstein
name: Technical University of Munich
First posted: 2024-02-09
Enrollment: 185
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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)


Eligibility criteria: 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

Primary outcomes:
measure: 6 Minute Walk Test (distance in metre)
timeFrame: Change in the total distance from T2 (6 months after enrollment) to baseline as target
Secondary outcomes:
measure: 6 Minute Walk Test (distance in metre)
timeFrame: Change in the total distance from T1 (end of chemotherapy, approx. week 18-19) to baseline as target
measure: Global physical activity questionnaire (GPAQ)
timeFrame: Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))
measure: Assessment of body composition using bioelectrical impedance analysis (BIA)
timeFrame: Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))
measure: Grip force dynamometer
timeFrame: Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))
measure: Polyneuropathy; item derived from EORTC CIPN20 (Item 9)
timeFrame: Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))
measure: Generalized Anxiety Disorder using GAD-2
timeFrame: Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))
measure: Adherence to a Mediterranean diet (MEDAS)
timeFrame: Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))
measure: EORTC QLQ-C30
timeFrame: Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))
measure: EORTC OV-28
timeFrame: Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))
measure: EORT FA-12
timeFrame: Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))
measure: Nutritional Risk Screening (NRS 2002)
timeFrame: Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))
measure: Brief Social Support Scale (BS6)
timeFrame: Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))
measure: Patient Activation Measure (PAM-13)
timeFrame: Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin
city: Dresden
country: Germany
facility: Universitätskrebszentrum Dresden
city: Essen
country: Germany
facility: Evang. Klinik Essen-Mitte
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
city: München
country: Germany
facility: Klinikum rechts der Isar der Technischen Universität München Ismaniger Straße 22
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Holger Schulz, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: