Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
185 participants
INTERVENTIONAL
2024-01-10
2025-12-31
Brief Summary
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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)
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Control group
usual care
No interventions assigned to this group
Intervention
6 month exercise and nutrition intervention
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Patients must be treated with surgery and chemotherapy
* Patients receiving adjuvant or neoadjuvant chemotherapy but not yet started
Exclusion Criteria
* Patients with inadequate German language skills
* Patients with physical or mental impairments that make it impossible to perform the training programs or study procedures
18 Years
FEMALE
No
Sponsors
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Charite University, Berlin, Germany
OTHER
University Hospital Dresden
OTHER
Kliniken Essen-Mitte
OTHER
University Hospital Tuebingen
OTHER
University Hospital Schleswig-Holstein
OTHER
Technical University of Munich
OTHER
Universitätsklinikum Hamburg-Eppendorf
OTHER
Responsible Party
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Principal Investigators
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Holger Schulz, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Universitätsklinikum Hamburg-Eppendorf
Locations
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Charité Universitätsmedizin Berlin
Berlin, , Germany
Universitätskrebszentrum Dresden
Dresden, , Germany
Evang. Klinik Essen-Mitte
Essen, , Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, , Germany
Universitätsklinikum Schleswig-Holstein
Kiel, , Germany
Klinikum rechts der Isar der Technischen Universität München Ismaniger Straße 22
München, , Germany
Universitätsklinikum Tübingen
Tübingen, , Germany
Countries
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Central Contacts
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Facility Contacts
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Jalid Sehouli, Prof. Dr.
Role: primary
Pauline Wimberger, Prof. Dr.
Role: primary
Philipp Harter, PD Dr.
Role: primary
Barbara Schmalfeldt, Prof. Dr.
Role: primary
Nicolai Maass, Prof. Dr.
Role: primary
Marion Kiechle, Prof. Dr.
Role: primary
Stefan Kommoss, Prof. Dr.
Role: primary
References
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Maurer 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.
Other Identifiers
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BENITA
Identifier Type: -
Identifier Source: org_study_id
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