Randomized Control Trial Comparing Efficacy of Benzydamine Mouth wash Vs Oral Honey Gargle in Prevention & Control of Oral Mucositis in Post- Operative Cases of Head & Neck Cancer receiving Adjuvant Radiotherapy.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 212
- 试验地点
- 1
- 主要终点
- To assess the efficacy [percentage of cases developing higher grade (3 and 4) of oral mucositis] of oral honey wash and gargle versus Benzydamine mouth wash in prevention and control of acute oral mucositis evaluated using radiation therapy oncology group (RTOG grading system).
研究概览
简要总结
Head and neck carcinomas are the most common cancer in India with oral cavity being the most common subsite and squamous cell carcinoma being the most common histology. Carcinoma of oral cavity is mostly confined to the primary site, with locoregional spread. Distant metastases are seen infrequently. Management of choice is usually definitive surgery, followed by adjuvant Radiotherapy with or without concurrent chemotherapy.
Radiotherapy is delivered by using varying techniques. IMRT plays a critical role in the management of patients with head and neck (H&N) cancer. The advantage of IMRT over older/conventional techniques is that it can conform the dose to any complex target volume and avoid critical Organs at Risk (OARs).
Oral mucositis is a frequent and distressing complication of adjuvant RT in patients treated for head and neck cancers. It significantly impairs oral intake, quality of life, and may necessitate treatment breaks, thereby compromising oncologic outcomes. Benzydamine mouthwash is currently recommended for mucositis prevention but may be associated with limitations such as availability, cost, and poor patient acceptability. Honey, a natural substance with proven anti-inflammatory and wound-healing properties, has shown potential in reducing mucositis severity in preliminary studies.
However, there is a lack of robust, randomized controlled trials comparing honey gargle directly with Benzydamine mouthwash in this clinical setting. This study seeks to address this gap by evaluating whether honey gargle is non-inferior to Benzydamine mouthwash in preventing and controlling oral mucositis among post-operative head and neck cancer patients receiving adjuvant RT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Histologically proven squamous cell carcinoma of oral cavity. 2.Age.
- •18 to 70 years 3.Both sexes 4.ECOG (Eastern Cooperative Oncology Group) 0-2 5.Adequate surgical resection of primary and nodal disease 6.Non-metastatic disease (T1-T4a, N0-3b). 7.Patients planned for adjuvant RT only with RT dose ranging from 60-64Gy in conventional fractions. 8.Patient able to read and write in their vernacular language.
排除标准
- •1.Patients with more than or equal to grade 2 trismus.
- •2.Pregnant or lactating women 3.Any histopathology other than Squamous cell carcinoma 4.Patient requiring concurrent chemotherapy.
- •5.Synchronous or Metachronous malignancy.
- •6.Metastatic disease (any T, any N, M1).
结局指标
主要结局
To assess the efficacy [percentage of cases developing higher grade (3 and 4) of oral mucositis] of oral honey wash and gargle versus Benzydamine mouth wash in prevention and control of acute oral mucositis evaluated using radiation therapy oncology group (RTOG grading system).
时间窗: To assess the efficacy [percentage of cases developing higher grade (3 and 4) of oral mucositis] of oral honey wash and gargle versus Benzydamine mouth wash in prevention and control of acute oral mucositis evaluated using radiation therapy oncology group (RTOG grading system). | Secondary objective- | 1. Duration of relief of oral mucositis. | 2. Frequency of high-grade (Grade 3 and 4) oral mucositis during treatment. | 3. Assessment of quality of life, local pain palliation via [Wong Baker Faces Pain Scale] in patients at start of RT, 6 weeks and 12 weeks post-RT.
Secondary objective-
时间窗: To assess the efficacy [percentage of cases developing higher grade (3 and 4) of oral mucositis] of oral honey wash and gargle versus Benzydamine mouth wash in prevention and control of acute oral mucositis evaluated using radiation therapy oncology group (RTOG grading system). | Secondary objective- | 1. Duration of relief of oral mucositis. | 2. Frequency of high-grade (Grade 3 and 4) oral mucositis during treatment. | 3. Assessment of quality of life, local pain palliation via [Wong Baker Faces Pain Scale] in patients at start of RT, 6 weeks and 12 weeks post-RT.
1. Duration of relief of oral mucositis.
时间窗: To assess the efficacy [percentage of cases developing higher grade (3 and 4) of oral mucositis] of oral honey wash and gargle versus Benzydamine mouth wash in prevention and control of acute oral mucositis evaluated using radiation therapy oncology group (RTOG grading system). | Secondary objective- | 1. Duration of relief of oral mucositis. | 2. Frequency of high-grade (Grade 3 and 4) oral mucositis during treatment. | 3. Assessment of quality of life, local pain palliation via [Wong Baker Faces Pain Scale] in patients at start of RT, 6 weeks and 12 weeks post-RT.
2. Frequency of high-grade (Grade 3 and 4) oral mucositis during treatment.
时间窗: To assess the efficacy [percentage of cases developing higher grade (3 and 4) of oral mucositis] of oral honey wash and gargle versus Benzydamine mouth wash in prevention and control of acute oral mucositis evaluated using radiation therapy oncology group (RTOG grading system). | Secondary objective- | 1. Duration of relief of oral mucositis. | 2. Frequency of high-grade (Grade 3 and 4) oral mucositis during treatment. | 3. Assessment of quality of life, local pain palliation via [Wong Baker Faces Pain Scale] in patients at start of RT, 6 weeks and 12 weeks post-RT.
3. Assessment of quality of life, local pain palliation via [Wong Baker Faces Pain Scale] in patients at start of RT, 6 weeks and 12 weeks post-RT.
时间窗: To assess the efficacy [percentage of cases developing higher grade (3 and 4) of oral mucositis] of oral honey wash and gargle versus Benzydamine mouth wash in prevention and control of acute oral mucositis evaluated using radiation therapy oncology group (RTOG grading system). | Secondary objective- | 1. Duration of relief of oral mucositis. | 2. Frequency of high-grade (Grade 3 and 4) oral mucositis during treatment. | 3. Assessment of quality of life, local pain palliation via [Wong Baker Faces Pain Scale] in patients at start of RT, 6 weeks and 12 weeks post-RT.
次要结局
- Secondary objective-(1. Duration of relief of oral mucositis.)
研究者
Dr Ashutosh Mukherji
Mahamana Pandit Madanmohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital, Varanasi