An Open Label, Randomized, Multicentric, Comparative Clinical Study to Evaluate theEfficacy and Safety of Oro-T ORAL RINSE (IN-100000264) in Mitigation and Treatment ofOral Mucositis during Cancer Radiotherapy with or without Chemotherapy in Head and NeckCancer Patients
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- 1.Percentage of subjects developing Oral Mucositis (WHO grade).
研究概览
简要总结
Oro-T ORAL RINSE is a polyherbal preparation for delaying the onset and treatment of Oral Mucositis in cancer patients undergoing chemotherapy or radiotherapy. Its natural ingredients help in reducing the inflammation, burning sensation, pain, risk of secondary infections, and promote faster healing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male or non-pregnant / non-lactating female Subjects between ≥18 to ≤65 years of age.
- •2.Subjects with histologically or cytologically confirmed Head and Neck cancer.
- •Subjects scheduled to receive radiotherapy as a continuous course of IMRT (Intensity-modulated radiation therapy) with single daily fractions of 2.0 to 2.2 Gy with a cumulative radiation dose between 60 Gy and 70 Gy With or without Chemotherapy: Subjects scheduled to receive a standard weekly regimen of Chemotherapy, which is prone to develop Oral Mucositis (e.g Regimens include Cisplatin / Cetuximab/ Paclitaxel/ Everolimus/ 5-FU).
- •Subjects with adequate visual access for examination of the oral cavity viz: lips, buccal mucosa, floor of mouth, ventral and lateral tongue and soft palate.
- •ECOG performance status ≤2
- •Subjects must have adequate marrow function.
- •Subject must consent to access, review and analysis of previous medical and cancer history, including imaging data by the sponsor or a third party nominated by the sponsor.
- •Ability to understand and sign a written informed consent document prior to any study-related procedures and ready to follow and in agreement to visits as per the study assessment visits.
- •Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraceptive measures (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study, and for 15 days following completion of study participation.
排除标准
- •1.Subjects with Metastatic disease
- •Subjects received chemotherapy or radiation treatment to the head and neck region within the previous 6 weeks
- •Presence of oral mucositis (WHO Score ≥ Grade 1) or other oral mucosal ulceration at study entry
- •Subjects requiring parenteral or gastrointestinal tube-delivered nutrition for any reason.
- •Subjects with presence of symptoms associated with Oral Mucositis like burning sensation, difficulty in chewing, difficulty in drinking and difficulty in mouth opening at the time of enrollment.
- •Known history/ case of HIV or active hepatitis B/C (patients who have been vaccinated for hepatitis B and do not have a history of infection are eligible)
- •Any significant, uncontrolled medical diseases or conditions, as assessed by the Investigators that would substantially increase the medical risks of participating in this study (i.e., uncontrolled diabetes, uncontrolled hypertension, NYHA II-IV congestive heart failure, myocardial infarction within 6 months of study, severe/ uncontrolled chronic pulmonary disease, uncontrolled clinically relevant pulmonary edema or active uncontrolled infection).
- •Subjects with inadequate hepatic and renal function.
- •Any other significant medical condition of oral cavity including untreated active oral or dental infection, including severe tooth decay (caries)
- •Evidence of immediate life-threatening disease or a life expectancy of less than 3 months as per Investigator’s discretion
- •Subjects who have participated in any investigational drug clinical study within one month of screening.
- •Refractory/ terminally ill patients.
- •Any systemic disorder (including Sjogren syndrome) which have direct impact on the normal condition of oral cavity.
结局指标
主要结局
1.Percentage of subjects developing Oral Mucositis (WHO grade).
时间窗: Visit 1- Screening (within 7 days prior to Day 1) | Visit 2- Baseline, Day 1 | Visit 3- At the end of 1st week/ Day 7 (±1day) | Visit 4- At the end of 2nd week/ Day 14 (±1day) | Visit 5- At the end of 3rd week/ Day 21 (±1day) | Visit 6- At the end of 4thweek/ Day 28 (±1day) | Visit 7- At the end of 5th week/ Day 35 (±1day) | Visit 8- At the end of 6thweek/ Day 42/completion of Radiotherapy/ Chemotherapy(±1day) | Visit 9- EOS: At 3 weeks post completion of Chemotherapy/ Radiotherapy (±1day)
2.Delay in the onset of Oral Mucositis.
时间窗: Visit 1- Screening (within 7 days prior to Day 1) | Visit 2- Baseline, Day 1 | Visit 3- At the end of 1st week/ Day 7 (±1day) | Visit 4- At the end of 2nd week/ Day 14 (±1day) | Visit 5- At the end of 3rd week/ Day 21 (±1day) | Visit 6- At the end of 4thweek/ Day 28 (±1day) | Visit 7- At the end of 5th week/ Day 35 (±1day) | Visit 8- At the end of 6thweek/ Day 42/completion of Radiotherapy/ Chemotherapy(±1day) | Visit 9- EOS: At 3 weeks post completion of Chemotherapy/ Radiotherapy (±1day)
To assess the comparative efficacy of Oro-T ORAL RINSE as compared to the Salt with or without Baking Soda water for Oral Mucositis during Cancer Radiotherapy with or without Chemotherapy in terms of:
时间窗: Visit 1- Screening (within 7 days prior to Day 1) | Visit 2- Baseline, Day 1 | Visit 3- At the end of 1st week/ Day 7 (±1day) | Visit 4- At the end of 2nd week/ Day 14 (±1day) | Visit 5- At the end of 3rd week/ Day 21 (±1day) | Visit 6- At the end of 4thweek/ Day 28 (±1day) | Visit 7- At the end of 5th week/ Day 35 (±1day) | Visit 8- At the end of 6thweek/ Day 42/completion of Radiotherapy/ Chemotherapy(±1day) | Visit 9- EOS: At 3 weeks post completion of Chemotherapy/ Radiotherapy (±1day)
次要结局
- 1.Incidence of intolerable mucositis(2.Incidence of delay in initiation of scheduled treatments (Radiotherapy/ Chemotherapy) due to Oral Mucositis.)