Clinical trial NCT03753932: Impact of Fixed Dentures in Head and Neck Cancer (IMFDHAC)
Official title: Patients With Head and Neck Cancer Treated by Radiotherapy: The Impact of Fixed Dentures on Wellbeing and Oral Health Related Quality of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Neoplasms
Dental Prosthesis
Dentures
Quality of Life
Lead sponsor: Region Jönköping County
Sponsor class: OTHER_GOV
Collaborators: name: School of Health Sciences, Jönköping University, Jönköping Sweden
name: Malmö University
First posted: 2018-11-27
Enrollment: 64
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group for the control vs. intervention group. Crossover model within the intervention group.
Primary purpose: TREATMENT

Brief summary: The purpose of the multi centre study is to evaluate an intervention, which means that patients undergoing radiotherapy for head and neck cancer will receive fixed dentures in accordance with the Public Health Care fee system with regard to well-being and oral health related quality of life.

Hypotheses: the intervention will improve oral health related quality of life, general wellbeing, and nutrition in patients treated by radiotherapy, with or without combination of chemotherapy or surgery against head and neck cancer.

Detailed description: The oncological care is multidisciplinary. In the investigation phase for radiotherapy, the Ear-Nose-Throat (ENT) physician refer the patient for a dental examination. Any dental infections are treated to reduce the risk of radiation-related infections that may occur after cancer treatment. This may mean that infected but symptom-free teeth, which the patient experiences as healthy need to be removed. This prophylactic dental treatment is charged according to the Public Health Care fee system.

The study will take place in one major and in four middle sized counties in Sweden. The intervention will include 30 patients with head and neck cancer recruited from a Department of Maxillofacial and Oral Surgery (the City of Jönköping, Jönköping County Council), and from the Department of Orofacial Medicine (the City of Stockholm, Stockholm County Council). Another 30 patients with the same disease will be matched controls recruited from another Department of Maxillofacial and Oral Surgery (the City of Linköping, County Council of Östergötland) and from five Departments of Orofacial Medicine (the Cities of Kalmar, Oskarshamn, and Västervik, Kalmar County Council; the City of Växjö, Kronoberg County Council).

The project consists of three sub-studies: A quantitative study; a qualitative study; and a health economics study. About 30 patients will be included in the intervention group, as well as about 30 matched control patients. Data collection will take place with questionnaires (SF-36, EQ-5D, OHIP-14, GOHAI, JFLS-8, OAS) and interviews.

Patients recruited to the intervention group will be treated prosthodontically with removable and later with fixed dentures, thus acting as their own controls.

If possible but not necessary, those controls may be prosthodontically rehabilitated with temporary removable dentures.

The inclusion criteria are patients with head and neck tumours considered to receive radiotherapy, with or without combination of chemotherapy or surgery, good oncological prognosis at baseline. After referral from an ENT-specialist, those patients being diagnosed with dental infections and therapy planned for dental extraction(s) will be included.

The following general exclusion criteria will be applied: any communication problems; any comorbidity with poor prognosis; poor oncological prognosis at baseline; imminent risk of recurrence; any technical, biological, or any other reasonable obstacle of treating patients with fixed dentures; and finally patients in the matched control group financing fixed oral prosthesis themselves.

Background data like sex, age, diagnosis, TNM-classification, hyposalivation, vertical jaw mobility, dysphagia, number and sites of extracted teeth, and weight will be investigated.

Statistical analysis, quantitative and qualitative, will show differences in well-being and mouth-related quality of life between the different groups studied.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with head and neck tumours considered to receive radiotherapy, with or without combination of chemotherapy or surgery
* Good oncological prognosis at baseline.
* Patients diagnosed with dental infections and therapy planned for dental extraction(s).

Exclusion Criteria:

* Unwillingness to participate in the study.
* Patients with communication problems.
* Patients with comorbidity with poor prognosis.
* Patients with poor oncological prognosis at baseline.
* Patients with imminent risk of recurrence.
* Patients with any technical, biological, or any other reasonable obstacle of treating patients with fixed dentures
* Patients in the matched control group financing fixed oral prosthesis themselves.

Primary outcomes:
measure: Oral Health Related Quality of Life (OHRQL), OHIP-14, BL/T1
timeFrame: Baseline
measure: Oral Health Related Quality of Life (OHRQL), OHIP-14, T2
timeFrame: 6 months after completed radiotherapy
measure: Oral Health Related Quality of Life (OHRQL), OHIP-14, T3
timeFrame: 12 months after completed radiotherapy
measure: Oral Health Related Quality of Life (OHRQL), GOHAI, BL/T1
timeFrame: Baseline
measure: Oral Health Related Quality of Life (OHRQL), GOHAI, T2
timeFrame: 6 months after completed radiotherapy
measure: Oral Health Related Quality of Life (OHRQL), GOHAI, T3
timeFrame: 12 months after completed radiotherapy
Secondary outcomes:
measure: Wellbeing, Quality of Life (QoL), SF-36v2, BL/T1
timeFrame: Baseline
measure: Wellbeing, Quality of Life (QoL), SF-36v2, T2
timeFrame: 6 months after completed radiotherapy
measure: Wellbeing, Quality of Life (QoL), SF-36v2, T3
timeFrame: 12 months after completed radiotherapy
measure: Wellbeing, Health Related Quality of Life (HRQoL), EQ-5D, BL/T1
timeFrame: Baseline
measure: Wellbeing, Health Related Quality of Life (HRQoL), EQ-5D, T2
timeFrame: 6 months after completed radiotherapy
measure: Wellbeing, Health Related Quality of Life (HRQoL), EQ-5D, T3
timeFrame: 12 months after completed radiotherapy
Other outcomes:
Locations:
city: Jönköping
country: Sweden
facility: Public Dental Health
Study officials:
affiliation: School of Health and Science, Jönköping Sweden
name: Dan Malm, Assoc Prof
role: STUDY_DIRECTOR
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