Oral complications in patients treated with hematopoietic stem cell transplantatio

Completed

Conditions: oral complaints
oral side effect
10018849

Registration Number: NL-OMON41813

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

* Patients diagnosed with a hematological malignancy, who will receive FIC or RIC, followed by autologous or allogeneic HSCT
* Patients older than 18 years.
* Able and willing to provide written informed consent

Exclusion Criteria

* Patients unable to give written informed consent.
* Patients younger than 18 years.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameters/endpoints:<br /><br>* Conditioning regimen (full intensity versus reduced intensity regimens with<br /><br>or without total body irradiation) and characteristics of subjective oral<br /><br>complications (e.g., pain, xerostomia, dysgeusia, dysphagia measured by patient<br /><br>reported outcomes) and objective oral complications (e.g., mucositis,<br /><br>infections, hemorrhage, gingivitis, periodontitis, dental caries, osteonecrosis<br /><br>and GVHD measured by validated scales)<br /><br>* Oral complications predictive for decreased QoL and negative clinical and<br /><br>economic outcomes (e.g., infections, use of antibiotics and opioid analgesics,<br /><br>parenteral nutrition, additional hospital visits, prolonged hospital stay,<br /><br>death)<br /><br>* Genetic polymorphisms in candidate genes (microarray analysis of salivary DNA<br /><br>samples) predictive for severe OM and GVHD</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Additional study parameters/endpoints of the Dutch side study:<br /><br>* Alterations of the oral microbial community (identified by open-end next<br /><br>generation sequencing) and in the salivary flow and proteome (MALDI-TOF, 2D-SDS<br /><br>PAGE and Mass Spectometry) in HSCT recipients developing severe OM and oral<br /><br>GVHD compared with those who do not.<br /><br>* Periodontal disease (measured by Plaque Index, Gingival Index, and<br /><br>Periodontal Pocket depth) predictive for developing severe OM and GVHD<br /><br>* Chronic oral GVHD and incidence and activity of dental caries (DMF-T and<br /><br>ICDAS-II score)<br /><br>* Alterations of the GI microbial community in HSCT recipients developing<br /><br>severe GI mucositis (diarrhea and citrulline levels) compared with those who do<br /><br>not </p><br>