“​ A Randomized controlled Trial to assess theeffectiveness of chewing gum on reducing incidenceand severity of chemotherapy induced oral mucositisand quality of life among patient receivingconventional mucotoxic chemotherapy.​ â€
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Reduction in incidence and severity of oral Mucositis after administration of chewing Gum.
研究概览
简要总结
A randomized controlled trial will be conducted in which subjects with conventional mucotoxic chemotherapy attending IRCH Day Care and ward at AIIMS, New Delhi and recieved at least one cycle of chemotherapy. eligible subjects will be identified on the basis of inclusion and exclusion criteria. informed consent will be obtained from subjects. Subjects will be randomized into experimental and control group using the computer generated table of random numbers, Baseline assessment of the subjects will be done for oral mucositis with the help of WHO grading system for oral mucositis and quality of life will be asssessed using OHIP-14 at 7th, 14th and 21st day. Everyday assessment will be done by patients using PROMS Questionairre (Patient Reported Oral Mucositis Scale) using a diary, Afterwards, weekly follow up till three weeks of therapy will be done.
For this study data will be collected from1st june 2021- 31Dec 2021.
Data analysis will be done by Descriptive/ Inferential Statistics.
The report will be submitted after data analysis.
In my inclusion criteria age is from 18yrs-65yrs but the value 18yrs could not get entered in the software(it is showing error again and again) and because of this error i have written age from 19yrs-65yrs.
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
- 19.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Adult patient of age 18yrs or more 2 Patients receiving conventional mucotoxic chemotherapeutic agents(such as Taxane group-Paclitaxel/Docetaxel Antimetabolites-5FU Methotrexate Cytarabine Anthracycline-Doxorubicin Alkylating agents-Cyclophosphamide 3 All new patients going for 1st cycle of conventional mucotoxic chemotherapy 4 Patient with controlled comorbidities 5 Patients with who are able to chew 6 Patients who are able to understand Hindi/English.
排除标准
- •1.Baseline NG tube.
- •2.Evidence of baseline infection.
- •3.Patients who are unable to chew.
- •4.Patients who are unable to understand Hindi/English.
结局指标
主要结局
Reduction in incidence and severity of oral Mucositis after administration of chewing Gum.
时间窗: At baseline and 7th day | At baseline and 14th day | At baseline and 21st day
次要结局
- Improvement in quality of life of patients.(Day 0,7th, 14th and 21st.)