Exercise and nutrition program for ovarian cancer patients
Exercise and Nutrition Intervention in Ovarian Cancer - Development of a Care Concept and Evaluation in Routine Clinical Practice
This study is testing if a 6-month exercise and nutrition program can help improve the physical health and quality of life for women with ovarian cancer during and after their treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 185 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Universitätsklinikum Hamburg-Eppendorf Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 7 sites (Berlin and 6 other locations) |
| Trial ID | NCT06250686 on ClinicalTrials.gov |
What this trial studies
This multicenter randomized controlled trial aims to evaluate the effectiveness of a 6-month exercise and nutrition intervention in improving physical functioning and quality of life for patients with ovarian cancer. Participants will be divided into an intervention group, which will engage in daily exercise and receive nutritional counseling, and a control group receiving usual care. The study will assess physical performance through a 6-minute walk test at three different time points: baseline, after chemotherapy, and after the intervention. The goal is to determine if the combined approach can enhance recovery during and after cancer treatment.
Who should consider this trial
Good fit: Ideal candidates are patients with FIGO II-IV stage ovarian, fallopian tube, or peritoneal carcinoma who are undergoing surgery and chemotherapy.
Not a fit: Patients with an ECOG performance status greater than 2 or those with significant physical or mental impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the physical performance and quality of life for ovarian cancer patients during and after treatment.
How similar studies have performed: Other studies have shown promising results with exercise and nutrition interventions in cancer care, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Berlin and 6 other locations
- Charité Universitätsmedizin Berlin — Berlin, Germany (Recruiting)
- Universitätskrebszentrum Dresden — Dresden, Germany (Not_yet_recruiting)
- Evang. Klinik Essen-Mitte — Essen, Germany (Recruiting)
- Universitätsklinikum Hamburg-Eppendorf — Hamburg, Germany (Recruiting)
- Universitätsklinikum Schleswig-Holstein — Kiel, Germany (Not_yet_recruiting)
- Klinikum rechts der Isar der Technischen Universität München Ismaniger Straße 22 — München, Germany (Not_yet_recruiting)
- Universitätsklinikum Tübingen — Tübingen, Germany (Not_yet_recruiting)
Study contacts
- Principal investigator: Holger Schulz, Prof. Dr. — Universitätsklinikum Hamburg-Eppendorf
- Study coordinator: Holger Schulz, Prof. Dr.
- Email: schulz@uke.de
- Phone: +49 (0) 40 7410 56806
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.