Trial Title:
Exercise and Nutrition Intervention in Ovarian Cancer
NCT ID:
NCT06250686
Condition:
Ovarian Cancer
Malnutrition
Muscle Wasting
Fatigue
Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Muscular Atrophy
Malnutrition
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Double (Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Behavioral
Intervention name:
combined exercise and nutrition intervention
Description:
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.
Arm group label:
Intervention
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)
Criteria for 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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Charité Universitätsmedizin Berlin
Address:
City:
Berlin
Zip:
13353
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Jalid Sehouli, Prof. Dr.
Investigator:
Last name:
Jalid Sehouli, Prof. Dr.
Email:
Principal Investigator
Facility:
Name:
Universitätskrebszentrum Dresden
Address:
City:
Dresden
Zip:
01307
Country:
Germany
Status:
Not yet recruiting
Contact:
Last name:
Pauline Wimberger, Prof. Dr.
Investigator:
Last name:
Pauline Wimberger, Prof. Dr.
Email:
Principal Investigator
Facility:
Name:
Evang. Klinik Essen-Mitte
Address:
City:
Essen
Zip:
45136
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Philipp Harter, PD Dr.
Investigator:
Last name:
Philipp Harter, PD Dr.
Email:
Principal Investigator
Facility:
Name:
Universitätsklinikum Hamburg-Eppendorf
Address:
City:
Hamburg
Zip:
20246
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Barbara Schmalfeldt, Prof. Dr.
Investigator:
Last name:
Barbara Schmalfeldt, Prof. Dr.
Email:
Sub-Investigator
Facility:
Name:
Universitätsklinikum Schleswig-Holstein
Address:
City:
Kiel
Zip:
24105
Country:
Germany
Status:
Not yet recruiting
Contact:
Last name:
Nicolai Maass, Prof. Dr.
Investigator:
Last name:
Nicolai Maass, Prof. Dr.
Email:
Principal Investigator
Facility:
Name:
Klinikum rechts der Isar der Technischen Universität München Ismaniger Straße 22
Address:
City:
München
Zip:
81675
Country:
Germany
Status:
Not yet recruiting
Contact:
Last name:
Marion Kiechle, Prof. Dr.
Investigator:
Last name:
Marion Kiechle, Prof. Dr.
Email:
Principal Investigator
Facility:
Name:
Universitätsklinikum Tübingen
Address:
City:
Tübingen
Zip:
72076
Country:
Germany
Status:
Not yet recruiting
Contact:
Last name:
Stefan Kommoss, Prof. Dr.
Investigator:
Last name:
Stefan Kommoss, Prof. Dr.
Email:
Principal Investigator
Start date:
January 10, 2024
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Universitätsklinikum Hamburg-Eppendorf
Agency class:
Other
Collaborator:
Agency:
Charite University, Berlin, Germany
Agency class:
Other
Collaborator:
Agency:
University Hospital Dresden
Agency class:
Other
Collaborator:
Agency:
Kliniken Essen-Mitte
Agency class:
Other
Collaborator:
Agency:
University Hospital Tuebingen
Agency class:
Other
Collaborator:
Agency:
University Hospital Schleswig-Holstein
Agency class:
Other
Collaborator:
Agency:
Technical University of Munich
Agency class:
Other
Source:
Universitätsklinikum Hamburg-Eppendorf
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06250686
