Prospective Studies on Saliva, Microflora, Diet, Oral Status and Quality of Life in Subjects Undergoing Radiation Therapy in the Head and Neck Region
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Changes in salivary secretion rate
研究概览
简要总结
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.
详细描述
In Europe, about 73 000 persons/year get cancer in the head and neck region. The treatment for oral cancer vary depending on tumour site and stage. Some subjects undergo surgery, some subjects are treated with chemotherapy in combination with the radiation and in some cases brachytherapy is used. Radiation therapy 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 referred to Dr. Bodil Fagerberg-Mohlin, before radiation therapy in the head and neck region are included. Data are collected at 5 occasions: before and during treatment as well as 6, 12 and 24 months after completed radiation therapy.
The subjects' cancer diagnosis, treatment, radiation doses, infections and medication are obtained from their medical records. Their odontological preventive treatment and use of other agents with fluoride such as saliva-stimulating chewing gum and tablets are registered.
Dietary habits are registered using a questionnaire focusing on intake of carbohydrate-rich food-items and items containing sugar-substitutes. The subjects are asked to fill in how often they use the items on a 6-grade scale. The subjects weight is registered before, during and after radiation therapy.
A clinical examination is performed before and 6, 12 and 24 months after completed radiation therapy. Panoramic x-rays are taken as well as bitewing radiographs. The number of teeth, caries status, oral hygiene are registered. Mucositis is registered during radiation therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •< 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
结局指标
主要结局
Changes in salivary secretion rate
时间窗: Pretreatment- two years post treatment
次要结局
- Changes in oral microflora(Pretreatment- two years post treatment)
