Clinical trial · Interventional
Exercise and Nutrition Intervention in Ovarian Cancer
Exercise and Nutrition Intervention in Ovarian Cancer - Development of a Care Concept and Evaluation in Routine Clinical Practice
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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)
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fatigue | — | UNRESOLVED | — |
| Malnutrition | — | UNRESOLVED | — |
| Muscle Wasting | — | UNRESOLVED | — |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| combined exercise and nutrition intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control group
- description
- usual care
- type
- EXPERIMENTAL
- label
- Intervention
- description
- 6 month exercise and nutrition intervention
- interventionNames
- Behavioral: combined exercise and nutrition intervention
Primary outcomes (1)
- measure
- 6 Minute Walk Test (distance in metre)
- timeFrame
- Change in the total distance from T2 (6 months after enrollment) to baseline as target
- description
- Sub-maximal exercise test used to assess aerobic capacity and endurance
Secondary outcomes (14)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDMaurer T, Belau MH, Zyriax BC, Welsch G, Jagemann B, Chang-Claude J, Daubmann A, Buchholz A, Glismann K, Moeller A, Sehouli J, Woopen H, Wimberger P, Harter P, Kaiser S, Maass N, Kiechle M, Engler T, Schmalfeldt B, Schulz H. Study protocol of an exercise and nutrition intervention for ovarian cancer patients during and after first-line chemotherapy (BENITA) - a randomized controlled trial. BMC Cancer. 2024 Nov 11;24(1):1379. doi: 10.1186/s12885-024-13102-y. PMID 39528997