Trial document




This trial has been registered retrospectively.
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  DRKS00013183

Trial Description

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Title

Association between severity of mucositis, changes in different saliva parameter and the cellular wound healing potency during and after a radiation therapy in case of cancer in the head neck area

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Trial Acronym

MuSWu1

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URL of the Trial

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Brief Summary in Lay Language

The aim of this study is to determine predictive parameters for the occurrence of radiation-induced mucositis in patients who have been treated with radiation in the head and neck area due to a tumour disease and thus often enable better individualisation of therapy. Patients are examined at the following times: before irradiation, regularly during irradiation, immediately after the last irradiation, 6-8 weeks after the last irradiation and 6 months after the last irradiation. The tooth status is recorded, the mucositis score is measured, the Xerostomia Inventory is collected, other clinical and quality of life associated parameters are recorded and unstimulated and stimulated saliva is collected to determine salivary flow rate, pH, buffer capacity and microbiome and proteome. In addition, mucosal biopsies should be taken before irradiation, which are treated in vitro comparable to clinical irradiation with ionizing radiation. In cell culture, these cells will be used to investigate whether the occurrence of mucositis can also be explained by different cellular radiation sensitivity. The data obtained in vitro should also be associated with the occurrence and severity of mucositis. This is intended to reveal whether patients show individually different radiation sensitivities.

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Brief Summary in Scientific Language

Persons who are irradiated in the head and neck area suffer from a large number of sequelae in the oral cavity. These include a reduction of salivary flow, which can result in the symptoms of the dry mouth, the occurrence of mucosal impairment (mucositis), infections in the oral cavity due to an imbalance of the oral microflora and the occurrence of caries as a long-term secondary disease. The relationship between the occurrence of secondary symptoms, especially the influence of changes in different saliva parameters (basic parameters, microbiome, proteome) on the occurrence of mucositis, as well as an individual cellular predisposition for the development of a mucositis have not been investigated so far. There are indications that the alteration of the proteome is associated with the occurrence of radiotherapy related mucositis and that microbiome changes as a result of radiotherapy. However, there is still need for research in this area. The planned study therefore aims to evaluate the sequelae of radiotherapy or radio-chemotherapy in the head and neck area with regard to changes in dental parameters, basic salivary parameters, saliva microbiome, and saliva proteome. The results should be associated with the occurrence and severity of radiation-induced mucositis. In addition, individual cell-associated parameters considering radiation sensitivity and wound healing potency under in vitro conditions should be investigated and also associated intra-individually with the occurrence and severity of a radiation-associated mucositis. In the future, the suitability of the microbiome or proteome as a predictive factor for the development of tumours in the oral region will be investigated.

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

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00013183
  •   2018/04/26
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  •   yes
  •   Approved
  •   449/16, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   K12.3 -  Oral mucositis (ulcerative)
  •   K11.7 -  Disturbances of salivary secretion
  •   Radiation-induced mucositis
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Interventions/Observational Groups

  •   Patients of the Department of Radiation Medicine will be recruited for the study if they receive primary radiochemotherapy (60-70Gy tumor dose and 2-3x 100mg/2 cisplatin) due to a locally advanced squamous cell carcinoma of the head and neck area. Clinical data are prospectively collected before and after radiotherapy; in particular, defined mucositis assessments, dental status (caries status, periodontal status), nutritional habits questionnaires, xerostomia assessment, quality of life, as well as the collection of saliva samples and a unique biopsy of the oral mucosa are planned.
  •   Since it cannot be excluded that the tumour disease already leads to a change in saliva parameters and/or cellular parameters, one age-matched and one sex-matched healthy control subject should be recruited for every two patients as a control group.
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Blinded
  •   assessor, data analyst
  •   Other
  •   Basic research/physiological study
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Association between clinical occurrence of mucositis and changes in quantitative and qualitative cell culture parameters and changes in microbiological, protein-based and basic saliva parameters

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Secondary Outcome

Change of basic saliva parameters (flow rate, pH, buffer cap.) by tumor-therapeutic radiation
Modification of microbial and protein-based saliva parameters by tumor-therapeutic radiation
Differences in microbial, protein-based and basic saliva parameters and in quantitative and qualitative cell culture parameters between patients and healthy control subjects

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/05/17
  •   50
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Patients: Age of majority, informed consent, sufficient knowledge of German, tumor in the oral cavity, oropharynx, hypopharynx or larynx, planned radiation in the head, neck area according to a standardized protocol (cisplatin-based radiochemotherapy with a radiation dose of 60-70 Gy in a fractionation of 5 x 2 Gy / week)

Controls: Age of majority, informed consent, sufficient knowledge of German

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Exclusion Criteria

Patients: Presence of xerostomia or hyposalivation prior to radiation, prior to tumor therapy drug intake with influence on salivation, prior to tumor therapy antibiotic or antifungal drug intake (currently up to three months prior to the start of the study), failed tooth restoration at the beginning of radiation (cavitated carious lesions, insufficient fillings down to the dentin, deep and inflamed periodontal pockets), allergies to the dental materials used and the local anaesthetic, complete or partial removal of the large salivary glands as part of surgical tumour therapy, pregnancy or breastfeeding.

Controls: Presence of xerostomia or hyposalivation, medication with influence on salivation, intake of an antibiotic or antifungal (currently up to three months before the start of the study), dentition in need of restoration (cavitated carious lesions, insufficient fillings down to the dentin, deep and inflamed periodontal pockets), allergies to the dental materials used and the local anaesthetic, complete or partial removal of the large salivary glands, pregnancy or nursing period

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Addresses

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    • Stiftungsprofessur für Kariesforschung Klinik für Zahnerhaltungskunde und Parodontologie Department f. Zahn-, Mund- u. KieferheilkundeUniversitätsklinikum Freiburg
    • Ms.  Prof. Dr.  Nadine  Schlüter 
    • Hugstetter Straße 55
    • 79106  Freiburg im Breisgau
    • Germany
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    • Stiftungsprofessur für Kariesforschung Klinik für Zahnerhaltungskunde und Parodontologie Department f. Zahn-, Mund- u. KieferheilkundeUniversitätsklinikum Freiburg
    • Ms.  Prof. Dr.  Nadine  Schlüter 
    • Hugstetter Straße 55
    • 79106  Freiburg im Breisgau
    • Germany
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    • Stiftungsprofessur für Kariesforschung Klinik für Zahnerhaltungskunde und Parodontologie Department f. Zahn-, Mund- u. KieferheilkundeUniversitätsklinikum Freiburg
    • Mr.  Benedikt  Luka 
    • Hugstetter Straße 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Gelder beantragt bei Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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Status

  •   Enrolling by invitation
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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.