Prevention of Oral Mucositis After Using Chamomile Oral Cryotherapy Versus Oral Cryotherapy in Pediatric Cancer Patients Receiving Chemotherapy: (A Randomized Pilot Study)
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in "patient-reported oral mucositis".
研究概览
简要总结
oral mucositis is a painful situation that significantly affects patients' quality of life with the severe cases being associated with ulcerated mucosa and secondary infection which may lead to life-threatening sepsis.Chamomile infusion in cryotherapy was used to aid in reduction of chemotherapy induced mucositis and to enhance the effect of standard cryotherapy alone by its anti-inflammatory, antifungal and antibacterial effect. The occurrence of oral mucositis is a significant complication of chemotherapy with prevalence of up to 80% in pediatric patients.The study is to be conducted at the in and outpatient clinics at the Department of Pediatric Oncology, National Cancer Institute,Egypt. A Structured interview questionnaire sheet will be filled with personal, medical and dental history. Intraoral examination will be carried out using sterile latex gloves, masks, plain mouth mirrors, sterile gauze and wooden tongue depressor. Patients who will agree to participate in the study will watch a video explaining how to perform oral hygiene.Preparation of the interventions is done in the clinic with 400 ml of distilled water with or without the infusion of 10 g of chamomile flowers."Chamomile classic infusion, Royal Herbs" .Ice cubes will be prepared in special ice trays placed in the chemotherapy center for this purpose.Patients will be instructed to swish the ice cubes around their oral cavities starting 5 minutes before chemotherapy infusion, continuing 30 minutes throughout the session and for additional 35 minutes after completion of intravenous chemotherapy session. Follow ups are done at the 8th,15th and the 21st day of interventions application.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with healthy and intact oral mucosa.
- •Patients diagnosed with bone tumor (osteosarcoma) for the first time.
- •Patients receiving Methotrexate as part of their chemotherapeutic regimen.
- •Both male and female patients undergoing chemotherapy at In and Out patient units of Pediatric Oncology department.
- •Age of patient ranging (6- 18) years old.
- •Legal representatives of patient must be able to read, understand and provide informed consent to participate in the trial.
- •Patients with no history of dental discomfort related to cold or hot food or beverage intake.
排除标准
- •Administration of antiviral or antifungal therapy and/or any other treatment for oral mucositis before enrollment in the study.
- •Presence of advanced or severe periodontitis (pocket depth more than 6mm).
- •Patients who were supposed to receive head and neck radiotherapy as part of their treatment.
研究组 & 干预措施
Chamomile oral cryotherapy
- The infusion of chamomile will be prepared in the clinic with 400 mL of distilled water and 10 g of chamomile flowers (Chamomile classic infusion, Royal Herbs).
- Ice cubes will be prepared in special ice trays placed in the chemotherapy center for this purpose.
- Patient will receive a cup of ice cubes which is continuously replenished before being emptied.
- Patients will be instructed to swish the ice cubes around their oral cavities starting 5 minutes before chemotherapy infusion, continuing 30 minutes throughout the session and for additional 35 minutes after completion of intravenous chemotherapy session.
干预措施: Chamomile oral cryotherapy (Other)
Oral cryotherapy
- The plain icecubes will be prepared in the clinic with 400 mL of distilled water.
- Ice cubes will be prepared in special ice trays placed in the chemotherapy center for this purpose.
- Patient will receive a cup of ice cubes which is continuously replenished before being emptied.
- Patients will be instructed to swish the ice cubes around their oral cavities starting 5 minutes before chemotherapy infusion, continuing 30 minutes throughout the session and for additional 35 minutes after completion of intravenous chemotherapy session.
干预措施: Oral cryotherapy (Other)
结局指标
主要结局
Change in "patient-reported oral mucositis".
时间窗: Assessed at the 8th, 15th and the 21st day after application of the interventions.
Primary outcome is measured using Children International Mucostitis Evaluation Scale (CHIMES).ChIMES1-4 each received a score of 0-5 where 5 is the worst degree of symptoms. ChIMES5 and ChIMES6 received a score of 1 or 0 if the child had received pain medications or not. Finally, ChIMES7 received a score of 1or 0 if oral ulcers were present or not. Any question that was scored as missing or 'I can't tell' was excluded from the total possible score. If all the questions were answered, the maximum score was 23. The ChIMES Total Score was the sum of all scores; 'I can't tell' responses and missing responses both received a score of 0. The ChIMES Percentage Score was the ChIMES Total Score over the total maximum score taking into account 'I can't tell' responses (by subtracting these items from the maximum score) multiplied by 100. Higher values indicate a worse outcome.
次要结局
- Change in "Clinical assessment of oral mucositis".(Assessed at the 8th,15th and the 21st day after application of the interventions.)
研究者
Dina Yousef Abdel Aleem Essa
Master Degree Student
Cairo University