Trial document





This trial has been registered retrospectively.
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  DRKS00012955

Trial Description

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Title

The impact of low FODMAP diet on rectal volume variability during external beam radiation therapy of prostate cancer

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Trial Acronym

[---]*

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URL of the Trial

[---]*

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Brief Summary in Lay Language

This study will evaluate the possibility of reducing the absolute volume and the variability of rectal volumes during radiotherapy by means of a low-FODMAP diet (FODMAP = Fermentable Oligo-, Di-, Mono-saccharides And Polyols). A confirmation of the hypothesis could improve local control and reduce toxicity by enhancing the precision of radiation.

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Brief Summary in Scientific Language

Verification of the hypothesis: The rectal volume and the interfractional variability of the rectum is significantly reduced by a low-FODMAP diet. Thus, a smaller part of the rectum is placed in the high-dose area (PTV). This leads to a reduction of gastrointestinal symptoms caused by radiation.

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Organizational Data

  •   DRKS00012955
  •   2017/08/29
  •   [---]*
  •   yes
  •   Approved
  •   366/16, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   C61 -  Malignant neoplasm of prostate
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Interventions/Observational Groups

  •   Consultation explaining the diet to the patient; start of low-FODMAP diet; planning-CT; radiation therapy; input of pseudonymized imaging data (planning CT and cone-beam CTs); establishing the testing parameters; mathematical evaluation of data
  •   Historical control group (no diet), data collected in 2015-16; these historical data are now compared with the data from Arm 1.
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Characteristics

  •   Interventional
  •   [---]*
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Historical
  •   Treatment
  •   Other
  •   I
  •   N/A
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Primary Outcome

Volume and Variability of interfractional rectal (wall) volumes

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Secondary Outcome

a) Overlapping volume of the rectal (wall) with PTV; b) Occurrence of gastrointestinal symptoms

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/01/02
  •   30
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Primary prostate cancer (primary or adjuvant radiotherapy), local recurrence or biochemical recurrence after resection; one planning-CT and three CBCTs from required periods available; written consent available

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Exclusion Criteria

CBCTs not according to requirements; coincidental radiation of lymphatic drainage pathways; condition after rectal amputation; dose escalation by means of brachytherapy; chronic inflammatory bowel diseases; opioid intake

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Addresses

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    • Universitätsklinikum Freiburg, Klinik für Strahlenheilkunde
    • Ms.  Prof. Dr. med.  Anca Ligia  Grosu 
    • Robert-Koch-Str. 3
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg, Klinik für Strahlenheilkunde
    • Mr.  Prof. Dr. med.  Thomas B.  Brunner 
    • Robert-Koch-Str. 3
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg, Klinik für Strahlenheilkunde
    • Mr.  Dr. med.  Constantinos  Zamboglou 
    • Robert-Koch-Str. 3
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Freiburg, Klinik für Strahlenheilkunde
    • Ms.  Prof. Dr. med.  Anca Ligia  Grosu 
    • Robert-Koch-Str. 3
    • 79106  Freiburg
    • 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.