Comparative Effectiveness of Ayurveda (Ay) Intervention and Conventional Prophylaxis for Radiotherapy-Induced Oral Mucositis in patients undergoing Primary or Adjuvant Radiotherapy without Chemotherapy for Oral Cancers: A Prospective, Randomized, Open Label, Active-Controlled Pilot Study

AyurVAID Hospitals1 个研究点分布在 1 个国家目标入组 40 人开始时间: 2024年5月20日最近更新: 2024年5月9日

试验速览

阶段: Phase 3 4
状态: 尚未招募
发起方
入组人数: 40
试验地点: 1
主要终点: 1.Weekly reduction of the percent incidence and severity of OM, defined as the

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This prospective, randomized, open-label, active-controlled Comparative Pilot study aimed to compare the effectiveness of Ayurveda intervention and conventional care in preventing or delaying grade 3 or higher oral mucositis (WHO Grading) in patients undergoing radiotherapy. The sample size in this study is 40. The consenting subjects will be randomized into two groups in 1 : 1 ratio. The Ayurveda intervention arm will be administered classical Ayurveda medicine for gargling and application in the oral cavity. The conventional care group will be given Benzadymine mouthwash. The study period will be nine weeks, and follow-up will be performed every week. The trial is expected to be completed within 6 months.

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.All oral cancer patients undergoing radiotherapy irrespective of type that are planned to be treated with primary or adjuvant Radiation Therapy using IMRT/3DCRT without chemotherapy.
•Treatment plan is to receive a continuous course of IMRT/3DCRT delivered as single daily fractions with a cumulative radiation dose of 60-70 Gy. Planned radiation treatment fields must include at least two oral sites (left and right buccal mucosa, floor of mouth, left and right ventral/lateral tongue, soft palate) that are each planned to receive a total of â‰¥ 60 Gy.
•Age 18 years or older
•Eastern Cooperative Oncology Group (ECOG) performance status â‰¤ 2
•Serum pregnancy test negative for females of childbearing potential
•Properly obtained written informed consent.

排除标准

•Other Head and Neck Cancers, tumour of the larynx, hypopharynx, nasopharynx, sinuses, or salivary glands or past cancers with high risk of recurrence
•Prior radiotherapy to the region of the Research cancer or adjacent anatomical sites or more than 25% of total body marrow-bearing area (potentially interfering with chemo tolerance)
•Concurrent participation in another interventional clinical Research or use of another investigational agent within 30 days of the first dose of /Conventional care
•Inability to eat soft solid food at baseline for reasons other than mouth soreness after surgery or dental procedures
•Complete reliance on parenteral or gastrointestinal tube-delivered nutrition at baseline
•Active infectious disease or ulcerative lesions or infections in the oral cavity at baseline
•Presence of oral mucositis at baseline.
•(Subjects with mouth or throat pain solely due to post-operative effects are eligible.)
•Known history of human immunodeficiency virus (HIV) or history of active hepatitis B/C (patients who have been vaccinated for hepatitis B and do not have a history of infection are eligible)
•Female patients who are pregnant or breastfeeding
•Known allergies or intolerance to Ay/Conventional Care compounds.