Clinical Registry of Dental Outcomes in Head and Neck Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 613
- 试验地点
- 10
- 主要终点
- Tooth loss
研究概览
简要总结
The purpose of this study is to measure the two-year rate of tooth loss in patients who have received external beam radiation therapy with curative intent for head and neck cancer. The study will also evaluate the sequelae of radiation therapy and oral complications that may occur as a result to receiving radiation therapy.
详细描述
This is a prospective cohort study to document dental and other oral outcomes in patients who receive external beam radiation therapy with curative intent, as part of clinical care for a head and neck cancer. Five hundred and seventy-five participants will be enrolled. All study participants will receive a baseline oral examination prior to the start of radiation therapy. Follow-up examinations and data collection will be conducted at six-month intervals up to 2 years after the start of radiation therapy. The primary outcome will be the two-year rate of tooth loss. Secondary outcomes will include measures of dental caries, periodontal health, salivary flow, and exposed bone/osteoradionecrosis.
The proposed research will provide more information to inform the community about the sequelae of Radiation Therapy (RT) in head and neck cancer patients, to refine current guidelines and to design future studies on the dental management of these patients.
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
- •Aged 18 years and older;
- •Willing and able to provide signed and dated consent form;
- •Diagnosed with head and neck squamous cell carcinoma (SCC) or a salivary gland cancer (SGC), and intends to receive external beam radiation therapy (RT) with curative intent (tumor eradication), with or without concomitant chemotherapy;
- •Diagnosed with a non-SCC, non-SGC malignancy of the head and neck region, and intends to receive RT, with or without concomitant chemotherapy. The subject must be expected to receive at least 4500 cGy to one of the following sites:
- •base of tongue
- •buccal/labial mucosa
- •floor of mouth
- •gingiva/alveolar ridge
- •hard palate
- •hypopharynx
- •maxillary sinus
- •nasal cavity
- •nasopharynx
- •oral cavity
- •oral tongue
- •paranasal sinus/orbit
- •parotid gland
- •retromolar trigone
- •soft palate
- •sublingual gland
- •submandibular gland
- •At least 1 natural tooth remaining or expected to remain in the mouth after completion of the pre-RT dental extractions, if any;
- •Willing to comply with all study procedures;
- •Willing to participate for the duration of the study.
排除标准
- •Receiving palliative RT;
- •History of prior curative RT to the head and neck region to eradicate a malignancy;
- •Incarcerated at time of screening;
- •Anything that would place the subject at increased risk or preclude the subject's full compliance with or completion of the study.
结局指标
主要结局
Tooth loss
时间窗: Two Years
The primary outcome measure is the two-year rate of tooth loss in patients who have received at least one session of external beam radiation therapy with curative intent for head and neck cancer. "Tooth loss" will be defined as a dental extraction that has been performed or recommended. Since dental extractions are often avoided in this population because of the increased risk of osteoradionecrosis (ORN), tooth loss will also include teeth having a dental procedure to avoid extraction of a tooth that would otherwise have been extracted if the individual had not received RT and teeth recommended for extraction that have not been treated. The following categories will constitute teeth that would otherwise be recommended for extraction: * non-restorable because of fracture or extent of caries; * amputated crown with root remaining; * uncontrolled or persistent periodontal or odontogenic infection.
次要结局
- Extraction complications(Within 14 days following procedure)
- Periodontal Measures(Baseline, 24 months)
- Quality of Life after Radiation Therapy(Baseline, 24 months)
- Decayed, Missing or Filled Surfaces (DMFS) Index(Baseline, 24 months)
- Incidence of exposed intraoral bone(Two Years)
- Oral Cancer Pain Scale(Baseline, 24 months)
- Stimulated Salivary Flow Rate(Baseline, 18 months)
- Trismus measure(Baseline, 24 months)
- Topical fluoride use for caries prevention(Baseline, 24 months)
- Chronic Oral Mucositis Incidence(Baseline, 24 months)