Ovarian CancerBENITANCT06250686
Exercise and Nutrition Intervention in Ovarian Cancer
A study testing combined exercise and nutrition intervention in people with Ovarian Cancer and Malnutrition, run by Universitätsklinikum Hamburg-Eppendorf at 7 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Malnutrition, Muscle Wasting
- What is being tested?
- combined exercise and nutrition intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 185 participants
- Where
- 7 sitesGermany
- Study dates
- 10 Jan 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Germany7 sites, 7 recruiting
- Recruiting
Charité Universitätsmedizin Berlin
Berlin, 13353
Jalid Sehouli, Prof. Dr.
Jalid Sehouli, Prof. Dr.
- Not yet recruiting
Universitätskrebszentrum Dresden
Dresden, 01307
Pauline Wimberger, Prof. Dr.
Pauline Wimberger, Prof. Dr.
- Recruiting
Evang. Klinik Essen-Mitte
Essen, 45136
Philipp Harter, PD Dr.
Philipp Harter, PD Dr.
- Recruiting
Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20246
Barbara Schmalfeldt, Prof. Dr.
Barbara Schmalfeldt, Prof. Dr.
- Not yet recruiting
Universitätsklinikum Schleswig-Holstein
Kiel, 24105
Nicolai Maass, Prof. Dr.
Nicolai Maass, Prof. Dr.
- Not yet recruiting
Klinikum rechts der Isar der Technischen Universität München Ismaniger Straße 22
München, 81675
Marion Kiechle, Prof. Dr.
Marion Kiechle, Prof. Dr.
- Not yet recruiting
Universitätsklinikum Tübingen
Tübingen, 72076
Stefan Kommoss, Prof. Dr.
Stefan Kommoss, Prof. Dr.
About this study
Official title: Exercise and Nutrition Intervention in Ovarian Cancer - Development of a Care Concept and Evaluation in Routine Clinical Practice
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:
Read more
- 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
- Ovarian Cancer, Malnutrition, Muscle Wasting, Fatigue
- Being tested
- combined exercise and nutrition intervention
- Medical subject headings
- Ovarian Neoplasms, Malnutrition, Muscular Atrophy, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combined exercise and nutrition interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | usual care |
| Intervention | Experimental | 6 month exercise and nutrition intervention Receives: Behavioral: combined exercise and nutrition intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 Minute Walk Test (distance in metre)
Sub-maximal exercise test used to assess aerobic capacity and endurance
Measured: Change in the total distance from T2 (6 months after enrollment) to baseline as target
Secondary outcomes (14)
6 Minute Walk Test (distance in metre)
Sub-maximal exercise test used to assess aerobic capacity and endurance
Measured: Change in the total distance from T1 (end of chemotherapy, approx. week 18-19) to baseline as target
Global physical activity questionnaire (GPAQ)
Physical activity in minutes per day, MET minutes per week
Measured: 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)
Bioelectrical impedance analyzers use an alternating electric current to measure the two components of bioelectrical impedance in the human body, resistance r and reactance Xc. In electrophysiological terms, resistance (per unit volume) correlates negatively with the amount of body fluid (body water and fat-free mass (FFM)) through which the current flows, while reactance correlates positively with the mass of body cells. The magnitude of Xc in relation to R is expressed as the phase angle (PA). From the measured R and Xc values and other subject data, additional indicators of body composition (e.g., total body water, fat-free mass, and fat mass) can be estimated using specific prediction equations based on modeling assumptions that are generally population-, age-, sex-, fat-, and disease-specific.
Measured: Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))
Grip force dynamometer
Hand gripping force (kg)
Measured: Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))
Polyneuropathy; item derived from EORTC CIPN20 (Item 9)
Problems standing or walking, because can't longer feel the ground under feet
Measured: 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)
Depression screening
Measured: 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
Anxiety
Measured: Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))
Adherence to a Mediterranean diet (MEDAS)
Adherence to a Mediterranean diet is assessed using the 14-item Mediterranean Diet Adherence Screener (MEDAS).
Measured: Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))
EORTC QLQ-C30
Quality of life (multidimensional) across 10 subscales
Measured: Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))
EORTC OV-28
Quality of life (multidimensional) focusing on ovarian cancer across 7 subscales
Measured: Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))
EORT FA-12
Quality of life (multidimensional) focusing on fatigue
Measured: Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))
Nutritional Risk Screening (NRS 2002)
Malnutrition risk
Measured: Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))
Brief Social Support Scale (BS6)
Social support (tangible support, emotional-informational support)
Measured: Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))
Patient Activation Measure (PAM-13)
Patient Activation Measure
Measured: Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start10 Jan 2024
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 185 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Collaborators
- Charite University, Berlin, Germany, University Hospital Dresden, Kliniken Essen-Mitte, University Hospital Tuebingen, University Hospital Schleswig-Holstein, Technical University of Munich
- Responsible party
- Sponsor
- Investigators
- Holger Schulz, Prof. Dr., Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06250686
- Sponsor's protocol ID
- BENITA
- Acronym
- BENITA
- Status last verified
- Feb 2024
- First submitted
- 4 Dec 2023
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study protocol will be published in a peer-reviewed journal at the outset. The Statistical Analysis Plan (SAP), Informed Consent Form (ICF), and analysis code will be provided upon request, if available at the time of request.
Publications
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.
PubMed 39528997
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise and Nutrition Intervention in Ovarian Cancer - Development of a Care Concept and Evaluation in Routine Clinical Practice
- ClinicalTrials.gov ID
- NCT06250686
- Acronym / sponsor ID
- BENITA / BENITA
- Conditions
- Ovarian Cancer, Malnutrition, Muscle Wasting, Fatigue
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 185 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Collaborators
- Charite University, Berlin, Germany, University Hospital Dresden, Kliniken Essen-Mitte, University Hospital Tuebingen, University Hospital Schleswig-Holstein, Technical University of Munich
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 9 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –usual care |
| Intervention | Experimental | Behavioral: combined exercise and nutrition intervention6 month exercise and nutrition intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| combined exercise and nutrition interventionPatients 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. | Behavioural | Intervention |
Primary outcome
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
14 secondary outcomes
6 Minute Walk Test (distance in metre)
Time frame: Change in the total distance from T1 (end of chemotherapy, approx. week 18-19) to baseline as target
Global physical activity questionnaire (GPAQ)
Time frame: 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)
Time frame: Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))
Grip force dynamometer
Time frame: Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))
Polyneuropathy; item derived from EORTC CIPN20 (Item 9)
Time frame: 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)
Time frame: 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
Time frame: Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))
Adherence to a Mediterranean diet (MEDAS)
Time frame: Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))
EORTC QLQ-C30
Time frame: Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))
EORTC OV-28
Time frame: Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))
EORT FA-12
Time frame: Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))
Nutritional Risk Screening (NRS 2002)
Time frame: Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))
Brief Social Support Scale (BS6)
Time frame: Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))
Patient Activation Measure (PAM-13)
Time frame: Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
- Derived from this study: PubMed 39528997Maurer 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.
- Individual participant dataSharing planned: No. The study protocol will be published in a peer-reviewed journal at the outset. The Statistical Analysis Plan (SAP), Informed Consent Form (ICF), and analysis code will be provided upon request, if available at the time of request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Holger Schulz, Prof. Dr. principal investigator
Universitätsklinikum Hamburg-Eppendorf
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing combined exercise and nutrition intervention in people with Ovarian Cancer and Malnutrition, run by Universitätsklinikum Hamburg-Eppendorf at 7 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Holger Schulz, Prof. Dr. (+49 (0) 40 7410 56806, schulz@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 Minute Walk Test (distance in metre) (time frame: Change in the total distance from T2 (6 months after enrollment) to baseline as target). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06250686, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2024.