Salivary Cytokines as Biomarker for Oral Health

Neoplasms Clinical Trial

— Cytosal  

Official title:

Salivary Cytokines in Paediatric Oncology Patients and Healthy Persons - A Pilot Study to Investigation of Biomarkers for Oral Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02807519
• Other study ID #: UKBB-2016/011
• Status: Completed
• Start date: December 2016
• Est. completion date: January 2021

Study information

• Verified date: February 2021
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Oral complications during and after cancer treatment are common. A key role in maintaining oral health plays saliva. In the last decade numerous studies have investigated immunological biomarkers such as cytokines in saliva samples. In children, the few studies have investigated salivary cytokines (sCK) suggesting that these are associated with oral health (sCK). One study investigating sCK in adult oncology patients showed an association between Interleukin-6 (IL-6) and severity of oral chronic graft-versus-host disease (GVHD) in survivors of hematopoietic stem cell transplantation. Therefore determination of sCK concentrations may also be helpful for assessment of GVHD activity and other inflammatory processes in cancer patients. In pediatric oncology patients, to the investigators' knowledge, no study has so far investigated sCK concentrations as markers for oral or systemic health.

Description:

Oral complications are common during and after cancer treatment. Oral mucositis typically occurs during or immediately after chemotherapy and may lead to pain, oral and systemic infection, and nutritional compromise. Late effects of oral mucositis as a result of cancer treatment include an increased risk for dental caries, xerostomia and osteonecrosis. It has been recognised, that regular assessment of oral health, prevention and early treatment of oral mucositis decreases early and late complication rates.

Saliva plays a key role in maintaining oral health and reduced salivary flow contributes to acute disorders and long-term sequelae in oral health. Saliva is a complex fluid secreted by the salivary glands and the gingiva. In the last decade numerous studies have investigated immunological biomarkers such as cytokines in saliva samples. These studies included individuals with various oral and systemic diseases including oral cancer, oral caries, autoimmune and endocrine diseases, metabolic syndrome, chronic kidney disease and psychiatric illnesses.

In children, the few studies that have investigated salivary cytokines (sCK) suggest that these are associated with oral health (sCK). For example, one study in 114 healthy adolescent girls aged 11-17 years showed that sCK concentrations were generally not associated with levels in the serum . In addition this study also suggested that the sCK concentrations are age dependent.

However, a number of other studies suggest that sCK may also reflect systemic diseases such as shown in a study including 20 children aged 9-17 with allergies (including asthma, allergic rhinitis and eosinophilic esophagitis) showing that Th-2 cytokines were detectable in sCK.

One study investigating sCK in adult oncology patients showed an association between IL-6 and severity of oral chronic GVHD in survivors of a hematopoietic stem cell transplantation. Therefore determination of sCK concentrations may also be helpful for assessment of GVHD activity and other inflammatory processes in cancer patients. In paediatric oncology patients, to the investigators' knowledge, no study has so far investigated sCK concentrations as markers for oral or systemic health.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: January 2021
• Est. primary completion date: August 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 18 Years

Eligibility

Inclusion Criteria:

• Children with confirmed haematological/oncological disease and necessity for radio-or chemotherapy

• Age > 4 and < 18 years.

Exclusion Criteria:

• patients, who already were treated with radio- or chemotherapy

• patients with current or previous (last 7 days) symptoms of a respiratory infection, rhinitis, bronchitis and tonsillitis

• children with an autoimmune disease

• Use of systemic antibiotics within the last 2 weeks.

• Use of antimicrobial mouth rinsing solution within the last 12 hours,

• any vaccination within the last 48 hours

• known allergy to paraffin.

Related Conditions & MeSH terms

• Neoplasms

Intervention

Genetic:
• collection of salivary cytokines
Collection of the saliva will be done following this procedure: The collection will be done prior to any other dental manipulation. The test person is sitting with its head tilted slightly forward. Initially, any saliva present in the mouth must be swallowed or spit out completely. Then, a paraffin gum is given to the test person. This paraffin gum must be chewed for minimally 2 and maximally up to 5 minutes. During the time period that the test person is chewing the paraffin gum, the saliva must be spitted into a cup repeatedly, or the saliva can also be let run passively into the cup. The amount of saliva is then weighted (1g equivalent to 1 ml) and a saliva flow rate (ml/min) is calculated and noted.

Locations

Country	Name	City	State
Switzerland	Kinderspital Aarau	Aarau
Switzerland	Schulzahlklinik Basel	Basel	Basel-Stadt
Switzerland	Volkszahnklinik	Basel	Basel-Stadt

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Schulzahnklinik Basel, Volkszahnklinik Basel

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mucositis (clinical oral finding)	clinical oral finding as mucositis in children with a hematological/oncological disease and healthy control children	18 months
Primary	salivary cytokine (sCK) levels	salivary cytokine (sCK) levels in children with a hematological/oncological disease and healthy control children	18 months
Primary	aphthous ulcer (clinical oral finding)	clinical oral finding as aphthous ulcer in children with a hematological/oncological disease and healthy control children	18 months