NCT06250686RecruitingNot Applicable
Exercise and Nutrition Intervention in Ovarian Cancer - Development of a Care Concept and Evaluation in Routine Clinical Practice
Universitätsklinikum Hamburg-Eppendorf7 sites in 1 country185 target enrollmentStarted: January 10, 2024Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 185
- Locations
- 7
- Primary Endpoint
- 6 Minute Walk Test (distance in metre)
Study Overview
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)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Control group
No Intervention
usual care
Intervention
Experimental
6 month exercise and nutrition intervention
Intervention: combined exercise and nutrition intervention (Behavioral)
Outcomes
Primary Outcomes
6 Minute Walk Test (distance in metre)
Time Frame: 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 Outcomes
- 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)))
- 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)
- 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)))
- EORTC QLQ-C30(Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26)))
- EORT FA-12(Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26)))
- Nutritional Risk Screening (NRS 2002)(Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26)))
- Brief Social Support Scale (BS6)(Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26)))
- Global physical activity questionnaire (GPAQ)(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)(Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26)))
- EORTC OV-28(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)(Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26)))
- Grip force dynamometer(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(Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26)))
- Patient Activation Measure (PAM-13)(Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26)))
Investigators
Study Sites (7)
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