Effect of Cold Application and Artificial Saliva in the Prevention of Chemotherapy-Induced Oral Mucositis in Patients With Cancer: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- Challacombe Scale of Clinical Oral Dryness
研究概览
简要总结
the Objectives of this clinical trial is :
- To determine the effect of Cold Application for preventing of chemotherapy-Induced oral mucositis in cancer patients.
- To examine the effect of artificial saliva for preventing of chemotherapy-Induced oral mucositis in cancer patients.
- To compare between the effect of artificial saliva and cold application for preventing of chemotherapy-Induced oral mucositis in cancer patients.
- To find out the differences between the effect of artificial saliva and cold application based on patient demographics and clinical data.
详细描述
The non-keratinized mucosa of the oral cavity including the tongue, buccal mucosa, and lips is particularly susceptible to injury, leading to ulcerative lesions clinically known as oral mucositis (OM). This common and impactful toxicity of standard cancer therapy, characterized by mucosal damage that can range from mild inflammation to deep ulceration.
In cases CIOM, the severity often requires major clinical interventions, including diet modification, opioid analgesics, and nutritional supplementation, to avoid disrupting optimal cancer therapy. Furthermore, CIOM can lead to superinfection, with the additional threat of bacteremia and sepsis. Patients with OM are more likely to experience negative treatment outcomes , and higher healthcare costs compared to those without the condition.
Oral mucositis (OM) notably reduces quality of life by causing both physical and psychological distress. This condition can lead to serious psychological issues like anxiety, depression, and social isolation. Moreover, pre-existing anxiety and depression may serve as risk factors for the development of oral mucositis. (Borowski et al., 2025).
Although the Multinational Association of Supportive Care in Cancer and International Society of Oral Oncology (MASCC/ISOO) have recommended some strategies, our knowledge regarding the prevention and treatment of CIOM remains limited, with no established evidence-based management regimens. This underscores the need to develop novel therapeutic drugs and strategies .
Cold application, commonly described as the cooling of the mouth during chemotherapy. is a valuable tool for preventing OM in patients receiving certain chemotherapeutic agents. It is safe and well-tolerated, and it can help to reduce the risk of complications .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who undergo chemotherapy.
- •Patients who do not have oral mucositis.
- •Patients who are aged 18 years and older.
- •Patients who are male or female.
- •Patients who agree to be included in the study sample.
排除标准
- •Patients who was refused to participate in the study.
- •Patients who was not undergoing chemotherapy.
- •Patients how was undergoing chemo-radiotherapy.
- •Patients who selected for pilot study.
- •Patients diagnosed with oral mucositis.
结局指标
主要结局
Challacombe Scale of Clinical Oral Dryness
时间窗: Baseline and Day 7
The Challacombe Scale is a clinician-administered tool for objectively assessing the severity of dry mouth (xerostomia) based on visual and tactile intraoral signs. It categorizes clinical oral dryness into ten grades (0 to 10), with increasing scores indicating greater severity. Key signs evaluated include mucosal appearance, saliva pooling, frothiness, and tongue features. This scale provides a standardized method to diagnose and monitor xerostomia
The World Health Organization (WHO) Oral Toxicity Scale
时间窗: Baseline and Day 7
The World Health Organization Oral Toxicity Scale, which was developed by the World Health Organization (WHO) in 1979. This scale categorizes oral mucositis (OM), a condition that involves inflammation and ulceration of the mucous membranes lining the oral cavity, into five different grades based on the severity of symptoms and their impact on diet and oral intake. Here is a brief overview of the five grades described in the scale. Grade 0: No Symptoms and diet is normal. Grade I: Soreness with or without erythematic (redness), and a solid diet is still possible. Grade II: Erythema and Ulcers present, and a soft or liquid diet is possible. Grade III: Confluent Ulcerations with or without exudates (discharge), and the person can only consume liquids. Grade IV: Deep Ulcerations and oral alimentation (consumption of food) is impossible. This grade is considered life-threatening.
Summated Xerostomia Inventory - SXI
时间窗: Baseline and Day 7
The Summated Xerostomia Inventory (SXI) is a validated patient-reported outcome measure (PROM) used to quantify the subjective symptoms of dry mouth (xerostomia).It composed of five items each item is scored on a five-point scale. Scoring is as follows: a Never response is scored as 1; Hardly ever scores 2; Occasionally scores 3; Frequently scores 4; and always scores 5. The scores for the 5 items are summed to give an overall SXI score which can range from 5 to 25. A higher score indicates more severe symptoms of xerostomia.
Challacombe Scale of Clinical Oral Dryness
时间窗: Baseline and Day 7
The Challacombe Scale is a clinician-administered tool for objectively assessing the severity of dry mouth (xerostomia) based on visual and tactile intraoral signs. It categorizes clinical oral dryness into ten grades (0 to 10), with increasing scores indicating greater severity. Key signs evaluated include mucosal appearance, saliva pooling, frothiness, and tongue features. This scale provides a standardized method to diagnose and monitor xerostomia
The World Health Organization (WHO) Oral Toxicity Scale
时间窗: Baseline and Day 7
The World Health Organization Oral Toxicity Scale, which was developed by the World Health Organization (WHO) in 1979. This scale categorizes oral mucositis (OM), a condition that involves inflammation and ulceration of the mucous membranes lining the oral cavity, into five different grades based on the severity of symptoms and their impact on diet and oral intake. Here is a brief overview of the five grades described in the scale. Grade 0: No Symptoms and diet is normal. Grade I: Soreness with or without erythematic (redness), and a solid diet is still possible. Grade II: Erythema and Ulcers present, and a soft or liquid diet is possible. Grade III: Confluent Ulcerations with or without exudates (discharge), and the person can only consume liquids. Grade IV: Deep Ulcerations and oral alimentation (consumption of food) is impossible. This grade is considered life-threatening.
Summated Xerostomia Inventory - SXI
时间窗: Baseline and Day 7
The Summated Xerostomia Inventory (SXI) is a validated patient-reported outcome measure (PROM) used to quantify the subjective symptoms of dry mouth (xerostomia).It composed of five items each item is scored on a five-point scale. Scoring is as follows: a Never response is scored as 1; Hardly ever scores 2; Occasionally scores 3; Frequently scores 4; and always scores 5. The scores for the 5 items are summed to give an overall SXI score which can range from 5 to 25. A higher score indicates more severe symptoms of xerostomia.
次要结局
未报告次要终点
研究者
Batool Abdulkareem Ahmed
Master's graduate student
Karbala University