Trial document




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  DRKS00020208

Trial Description

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Title

Combined Intervention of nutritional and sports therapy during oncological treatment

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Trial Acronym

INTEGRATION program

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URL of the Trial

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Brief Summary in Lay Language

Due to a combined and personalized nutritional and sports therapy across all sectors, the INTEGRATION program has the goal to reduce side effects during anti-cancer treatment and increase the rehabilitation potential.

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Brief Summary in Scientific Language

The INTEGRATION program investigates the feasibility of a combined nutritional and sports therapy during anti-cancer treatment. Besides we will analyse the effects of this porgram in a RCT design with pre, interims and post tests.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00020208
  •   2020/07/08
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  •   yes
  •   Approved
  •   20-1044_1, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

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Health Condition or Problem studied

  •   Initial oncological diagnosis before outpatient, systematic, first line therapy (Chemotherapy, radiotherapy, combined chemo- and radiotherapy, immunetherapy) with a life expectancy of more than 18 months.
  •   C00-C97 -  Malignant neoplasms
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Interventions/Observational Groups

  •   New care form consisting of a combined, personalized, integrative and supervised nutritional und sports therapy over 6 months
  •   Usual care: Recommendations of nutritional and sports therapy not personalized, supervised or structured
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Placebo
  •   Supportive care
  •   Parallel
  •   III
  •   N/A
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Primary Outcome

Decreasing the number of patients in need of nutritional and sports therapy after oncological treatment.

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Secondary Outcome

Decreasing in Mortality and morbidity. Increasing motivation to be more physical active. Improving body composition, quality of life and treatment success. Minimize health care costs.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2020/10/01
  •   400
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Initial oncological diagnosis before outpatient, systematic, first line therapy (Chemotherapy, radiotherapy, combined chemo- and radiotherapy, immunetherapy) with a life expectancy of more than 18 months. ECOG status higher than 2. Valid consent form.

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Exclusion Criteria

Recurrence of diagnosis. Need of intensive medical care (inpatient). Only local therapy (radiotherapy or operation). Life expactency under 18 months. NYHA III-IV. Hypertension status 3-4. Unstable respiratory global insufficiency. Clinically manifest and uncontrolled coagulation disorders. Uncontrolled cerebral spasms. Bad psychological condition leading to not being able to sign letter of consent. Participation in other sports or nutritional intervention studies. Lack of willingness to store and disseminate personal disease data under the protocol

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Addresses

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    • Universitätsklinikum Köln (AöR)
    • Kerpenerstraße 62
    • 50937  Köln
    • Germany
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    • LMU Klinikum MünchenMedizinische Klinik und Poliklinik III
    • Mr.  Prof. Dr.  Sebastian  Theurich 
    • Ziemssenstr. 1
    • 80336  München
    • Germany
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    • Universität zu KölnUniklinik Köln Innere Medizin I
    • Mr.  PD DR  Freerk  Baumann 
    • Kerpenerstraße 62
    • 50937  Köln
    • Germany
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    • Universität zu Köln Uniklinik zu Köln Innere Medizin I
    • Mr.  PD Dr  Freerk  Baumann 
    • Kerpenerstraße 62
    • 50937  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Gemeinsamer Bundesausschuss
    • Gutenbergstraße 13
    • 10587  Berlin
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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