Evaluation of Mucoheal Rinse and Mucoheal Chocolate in the Management of Chemo-Radiation Induced Mucocitis: An Exploratory Clinical Trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 12
- 试验地点
- 1
研究概览
简要总结
This prospective, single-arm interventional study evaluates the efficacy and safety of Mucoheal chocolate and Mucoheal rinse in the management of chemo-radiation induced oral mucositis in cancer patients. A total of 12 patients will receive Mucoheal chocolate twice daily and Mucoheal oral rinse three times daily for 4 weeks, with follow-up assessments on the 7th, 14th, 21st, and 28th day.Outcomes will be assessed using standardized mucositis grading scales including WHO Oral Toxicity Scale, NCI-CTCAE , RTOG/EORTC scale, OMAS, and Modified Oral Mucositis Index , along with evaluation of pain, healing time, treatment compliance, tolerability, and patient-reported outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Known case of any type of cancer receiving chemotherapy or radiation therapy irrespective of duration, aged 18 to 75 years, of any gender, and presenting with oral mucositis, assessed using standardized and validated grading systems, including World Health Organization Oral Toxicity Scale RTOG/EORTC Oral Toxicity Scale Oral Mucositis Assessment Scale NCI–CTCAE National Cancer Institute – Common Terminology Criteria for Adverse Events Scale.
排除标准
- •Patients with pre-existing oral lesions or infections example oral candidiasis, herpes simplex, leukoplakia prior to initiation of chemotherapy or radiotherapy.
- •Patients with active systemic infections or febrile illness at the time of enrollment.
- •Patients with autoimmune or inflammatory oral conditions example oral lichen planus, pemphigus vulgaris.
- •Patients not willing to continue ongoing topical or systemic medications for oral mucosal conditions during the trial period.
研究者
Dr Swapnali bandu naik
Dr. D. Y. Patil College of Ayurved and Research Centre