Oral Care Protocol for the Management of Chemotherapy and Radiation Therapy-Induced Oral Mucositis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Oral Mucositis Severity - WHO Scale
研究概览
简要总结
The purpose of this study is to determine the effects of a novel oral care protocol on the severity and pain of oral mucositis in patients receiving radiation and/or chemotherapy for head and neck cancers. The secondary objectives are to characterize the microbiome associated with oral mucositis, measure salivary proinflammatory cytokines, and evaluate other clinical indicators of the intervention. Participants will be enrolled prior to beginning radiation and/or chemotherapy, and will be randomized to receive either the oral health protocol or standard of care oral hygiene.
详细描述
Oral mucositis (OM) is one of the most debilitating adverse effects in cancer patients treated with chemotherapy or radiation (RT). Currently, there are no effective therapies or prevention for mucositis, while several clinical studies have suggested that professional oral care could effectively reduce the severity of Radiation Therapy or chemotherapy-induced oral mucositis. Palliative treatment, rather than preventive or curative measures, remains the standard of care. Evidence-based guidelines do not provide consistent recommendations for the prevention, treatment and management of oral mucositis.
The investigators hypothesize that a monitored regimen of professional oral hygiene prevents harmful ecological shifts in the oral cavity, improve oral health and reduce the duration and severity of Oral Mucositis in cancer patients, consequently improving their overall quality of life during treatment. Moreover, the investigators hypothesize that the weekly oral hygiene regimen performed by an oral health professional is more effective in treating and preventing mucositis than current standard-of-care treatments.
The principal investigator of this project has developed a novel oral care regimen protocol for the treatment of oral mucositis. The "Oral Mucosa Deterging and Periodontal Debridement" (OMDP) protocol consists of a regimen of frequent professional oral prophylaxis including tooth cleaning, tooth polishing and flossing, and the debridement of the periodontium and deterging of the oral mucosa. This is an intervention that is implemented prior to and maintained throughout the entire cycle of the radiation or chemoradiation. Co-adjuvant treatments such as intense fluoride treatments, oral hygiene instructions and palliative mouth-rinses are also part of the protocol. The hypothesis is that repeated professional prophylaxis of the oral cavity would protect the healthy oral tissue against infection and inflammation often associated with severe cases of mucositis, and consequently reduces mucositis incidence and duration.
Participants in this study would attend approximately 9 study visits over the course of 16-18 weeks, depending on their specific cancer treatment plan. Study participants will be randomized to receive either the oral health protocol, which they will receive on a weekly basis, or standard of care oral hygiene instructions and tooth brushing, preformed on a bi-weekly basis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Male and female patient aged 18 years or older;
- •Patients must sign an informed consent before data collection, screening, or initiation of study procedures;
- •Patients who are scheduled to undergo radiation or chemoradiation treatment for head/neck cancer;
- •Patients who have a minimum of 6 natural teeth at the time of enrollment.
排除标准
- •Female patients who are pregnant or lactating at the baseline/screening visit;
- •Patient participating in another biomedical/oral health research study that would interfere with participating in this study;
- •Patient deprived of freedom, under supervision or guardianship;
- •Patient unable to attend to scheduled medical monitoring due to geographical, social or mental reasons;
- •Immune compromised or other serious medical conditions, regardless of whether the condition is controlled or not;
- •Patient who requires pre-medication prior to dental treatment;
- •Any patient, in the opinion of the Investigator, who is unable or unlikely to comply fully with the study requirements or procedures for any reason (e.g. major surgical resection of intra-oral structures which would prevent oral care intervention, edentulous, severe periodontal disease, etc).
结局指标
主要结局
Oral Mucositis Severity - WHO Scale
时间窗: End of Radiation Treatment (approximately week 7)
OM severity will be assessed by the WHO Oral Mucositis Scale at each follow-up visit. The WHO Oral Mucositis Scale is a 5 point scale (0 to 4) with the following scoring system: 0=None 1. Soreness with erythema 2. Erythema, ulcers, can eat solids 3. Ulcers, liquid diet only 4. Alimentation not possible
Oral Mucositis Severity - NCI Scale
时间窗: End of Radiation Treatment (approximately week 7)
OM severity will be assessed by the NCI-CTCAE Scale (National Cancer Institute - Common Toxicity Criteria and Grading of Adverse Events) at each follow-up visit. The NCI-CTCAE is a 5 point scale (1-5) with the following grading system: 1. Erythema of the mucosa 2. Patchy ulcerations or pseudomembranes 3. Confluent ulcerations or pseudomembranes; bleeding with minor trauma 4. Tissue necrosis; significant spontaneous bleeding; life-threatening consequences 5. Death
次要结局
- Level of Oral Pain (FACES Scale)(End of Radiation Treatment (approximately week 7))
- Mean Difference in the Relative Abundance of Oral Microbial Species of the Tongue (Right Side) From Baseline to Onset of Oral Mucositis(Baseline to Onset of Oral Mucositis)
- Mean Difference in the Relative Abundance of Oral Microbial Species of the Cheek (Left Side) From Baseline to Onset of Oral Mucositis(Baseline to Onset of Oral Mucositis)
- Mean Difference in the Relative Abundance of Oral Microbial Species of the Cheek (Right Side) From Baseline to Onset of Oral Mucositis(Baseline to Onset of Oral Mucositis)
- Mean Difference in the Relative Abundance of Oral Microbial Species of the Tongue (Left Side) From Baseline to Onset of Oral Mucositis(Baseline to Onset of Oral Mucositis)
- Change in the Level of Salivary Proinflammatory Cytokines From Baseline to 16 Weeks(Baseline and 16 weeks (final study visit))
- Change in Quality of Life as Measured by the Composite Score of the EORTC(Baseline to the peak of mucositis (approximately week 4))