Clinical trial · Observational
Prospective Studies on Oral Health and Quality of Life in Head and Neck Cancer Patients
Prospective Studies on Saliva, Microflora, Diet, Oral Status and Quality of Life in Subjects Undergoing Radiation Therapy in the Head and Neck Region
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Radiation therapy (RT) leads to a markedly reduced salivary secretion rate, which makes it difficult to eat and talk and it is a risk factor for oral disorders such as caries and mucosal infections. A reduced salivary secretion rate is often a life long side-effect of the treatment that seriously affect the quality of life. To reduce these side-effects the patients get preventive and supportive oral treatment in connection with their cancer treatment. However, regardless of radiation doses given, the severity of the problems vary considerably. Therefore, a better understanding on when and why problems occur is important for the identification of subjects at risk and to find better measures and treatments, suited for their individual needs. Dentate subjects were included referred before RT. Data were collected before and during treatment as well as 6, 12 and 24 months after completed RT. Cancer diagnosis, treatment, radiation doses, infections and medication were obtained from medical records. Dietary habits were registered using a questionnaire focusing on intake of carbohydrate-rich food-items and items containing sugar-substitutes. The subjects weight was registered before, during and after RT. A clinical examination was performed before and 6, 12 and 24 months after completed RT. Panoramic x-rays were taken as well as bitewing radiographs. The number of teeth, caries status, oral hygiene were registered. Mucositis was registered during RT. Secretion of stimulated whole saliva was determined. Minor labial and buccal gland saliva secretion rate was determined using the Periotron-method. Microbial samples were collected from the tongue, buccal mucosa and supragingival plaque and microorganisms associated with oral health and oral disorders analysed using cultivation technique. The quality of life was registered using the questionnaires EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire). To address additional symptoms associated specifically with cancer in the head and neck region and its treatment, a complementary 35-item module, the EORTC QLQ-H\&N35 was used. The patients also completed the Hospital Anxiety and Depression Scales, HADS, which is used to measure severity of anxiety and depressive symptoms and provides estimates of possible mood disorders in patients with somatic comorbidity.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mouth Diseases | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
| Secretion; Salivary Gland, Deficient | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cancer treatment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Head and neck cancer patients
- description
- Patients with head and neck cancer who were ≥ 18 years old and had ≥ 16 teeth and no removable prosthesis or dental implants consisting of more than one teeth were included
- interventionNames
- Other: Cancer treatment
Primary outcomes (1)
- measure
- Changes in salivary secretion rate
- timeFrame
- Pretreatment- two years post treatment
Secondary outcomes (1)
- measure
- Changes in oral microflora
- timeFrame
- Pretreatment- two years post treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 18 years or older 16 or more own teeth No removable prosthesis No dental implants consisting of more than one tooth Able to read and understand Swedish Exclusion Criteria: \< 18 years old \< 16 teeth Removable prosthesis Dental implants consisting of more than one tooth Severe cognitive impairment Unable to read and/or understand Swedish
References
Publications (1)
- RESULTAlmstahl A, Alstad T, Fagerberg-Mohlin B, Carlen A, Finizia C. Explorative study on quality of life in relation to salivary secretion rate in patients with head and neck cancer treated with radiotherapy. Head Neck. 2016 May;38(5):782-91. doi: 10.1002/hed.23964. Epub 2015 Jun 20. PMID 25537660