Trial document





This trial has been registered retrospectively.
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  DRKS00013231

Trial Description

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Title

Exercise and nutrition intervention for ovarian cancer patients during and after first line chemotherapy - pilot study

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Trial Acronym

BENITA

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Ovarian Cancer is one of the most common female gynaecological cancers. In Germany approximately one in 72 women develops cancer during her life course. Compared to other cancers life expectancy for ovarian cancer patients remains poor, which is mainly due to the fact that symptoms in the early stages of disease are subtle and remain undiagnosed until a late-stage of disease progression. Bad prognosis and a very aggressive form of treatment often lead to decreases in quality of life. Therefore both enhancements in quality of life as well as prognosis are important research goals. Two major symptoms of ovarian cancer and its treatment are malnutrition and muscle wastage. Lack of movement due to decrease in body function through muscle wastage and nutrition deficits worsen prognosis. It is suspected that physical activity and a healthy diet during and after active treatment could have a positive effect on patient's quality of life and survival. The BENITA-study aims to investigate the hypothesis, that an individual sports and nutrition program during and after treatment will affect patient's course of disease and quality of life. The BENITA-study is a so called randomized controlled trial, which means that patients who agree to participate are randomly allocated to one of two groups. One group (the intervention group) receives an individual sports and nutrition program in addition to the usual care provided by the hospital while the other group (control group) receives the hospital's usual care. The whole intervention takes two years and starts during active treatment. This is of special importance, because muscle wastage and malnutrition often occur during this period.

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Brief Summary in Scientific Language

In contrast to other cancers ovarian cancer patients have not yet benefitted from major breakthroughs in treatment to improve chances of recovery. Survival rates as stated by the Robert-Koch Institute are poor with only 41% alive five years after diagnosis. Major side-effects of ovarian cancer and its treatment are muscle wasting and malnutrition leading to decreased quality of life (QoL) and reduced survival times. As muscle wasting and malnutrition often co-occur, as described in cancer cachexia, it is believed that reducing malnourishment in advanced cancer patients through nutrition counselling in combination with exercise interventions will be most effective. Research on cancer cachexia suggests that care programs should intervene at an early stage of the syndrome to prevent further development into a refractory state.
We hypothesize that (1) a combined exercise and nutrition intervention during and after chemotherapy will significantly improve progression-free survival of ovarian cancer patients (2) and extended exercise and nutrition intervention will improve patient reported outcomes such as fatigue, QoL, depression or sleep quality (3) an exercise and nutrition intervention during and after chemotherapy will enhance or stabilize muscle function (defined as muscle mass and muscle composition) in ovarian cancer patients.
A randomized controlled two-armed trial is designed to compare an individualised exercise and nutrition intervention to usual care in stage II-IV ovarian cancer patients with respect to progression-free survival at 36 months. Patients are randomized 1:1 to a 24-months resistance exercise training (RET) and dietary intervention during chemotherapy and thereafter.
A two year monocentric pilot study precedes the main study to ensure the feasability of the intervention. If necessary changes in the study design can be made based on the experiences made during pilot phase. A total of 30 patients will be recruited to participate in the pilot study (15 patients per arm).

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Organizational Data

  •   DRKS00013231
  •   2018/09/07
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  •   yes
  •   Approved
  •   PV5456 , Ethik-Kommission der Ärztekammer Hamburg
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Secondary IDs

  •   U1111-1205-9596 
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Health Condition or Problem studied

  •   C56 -  Malignant neoplasm of ovary
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Interventions/Observational Groups

  •   Intervention is divided into three phases.

    Exercise Intervention:
    Phase I (week 1-18): Intensive supervised daily home-based strength training session for 15-30 minutes with weekly counseltation/update calls. Training focuses on stabilisation and flexibility enhancement.

    Phase II (week 19-52): After completion of chemotherapy. Daily home-based training for 15-30minutes. Monthly personal counselling with individually adapted exercise assignments.

    Phase III (week 52-104): Daily home-based training. Every three months counselling with new exercise assignments.

    Nutrition Intervention:
    Phase I (week 1-18): 30-45 min in-person nutrition counselling every 3 weeks based on the “Deutsche Gesellschaft für Ernährungsmedizin (DGEM)” and WCRF. Method of motivational interviewing (MI) will be applied. Detailed dietary intake assessment using the “Freiburger Ernährungsprotokoll” and anamnesis sheet to create individual nutritional plan. Additional recipe book with information about calorically balanced and healthy snacks and drinks. If required patients can be given oral supplementation (sip-feeding or powder) or enteral/parenteral nutrition.

    Phase II (week 19-52): After completion of chemotherapy. Monthly in person counselling session to learn about the Mediterranean diet. One in person counselling is organized as a cooking class.

    Phase III (week 52-104): Personal consultation every three months. Focus on Mediterranean diet and individual problems.
  •   Control group: The control groups receives a one time general conseltation about healthy diet and physical activity in cancer patients (usual care).
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   investigator/therapist, data analyst
  •   Control group receives no treatment
  •   Other
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Primary endpoint is the feasibility of the study assessed through:
1. Recrutiment rate
2. Adherence
3. Completion rate
4. Side-effects

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Secondary Outcome

/

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2018/04/02
  •   30
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   100   Years
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Additional Inclusion Criteria

•Women ≥ 18 years of age
•Women diagnosed with ovarian cancer, tubal cancer or peritoneal cancer(Carcinoma of one or both ovaries, confirmed histologically by core biopsy) and primary or interval debulking surgery
•Secondary tumors less than five years before ovarian cancer diagnosis
•Scheduled for adjuvant or neoadjuvant chemotherapy (but not yet started)
•Sufficient German language skills
•Signed informed consent

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Exclusion Criteria

•ECOG status of 2 or worse
•Any physical or mental conditions that would hamper the performance of the training programs or the completion of the study procedures
•Private engagement in exercise training (at least 1h twice per week)
•Women diagnosed with eating disorder

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Addresses

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    • Universitäres Cancer Center Hamburg
    • Martinistraße 52
    • 20246  Hamburg
    • Germany
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    • Universitäres Cancer Center Hamburg
    • Ms.  Prof. Dr.   Jenny  Chang-Claude 
    • Martinistraße 52
    • 20246  Hamburg
    • Germany
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    • Universitäres Cancer Center Hamburg
    • Ms.  Dipl. Psych  Tabea  Kühl 
    • Martinistraße 52
    • 20246  Hamburg
    • Germany
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Sources of Monetary or Material Support

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    • Hamburger Krebsgesellschaft
    • Mr.  Prof. Dr. med.  Ulricht R.  Kleeberg 
    • Butenfeld 18
    • 22529  Hamburg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.