Oral Cryotherapy for prevention of Oral mucositis following high dose methotrexate in children with Acute Lymphoblastic Leukemia: A Randomised controlled study.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Percentage of children with ALL who developed oral mucositis in oral
研究概览
简要总结
This study will be conducted at the Department of Pediatrics, Atal Bihari Vajpayee Institute of
Medical Sciences and Dr Ram Manohar Lohia Hospital.
Children (aged 2 to 18 years) with acute lymphoblastic leukemia due for receiving first highdose methotrexate from 15th April 2024 till 30th June 2025 will be included in the study. Those
children who fulfill the inclusion criteria will be enrolled after taking Written Informed consent
from parents/ caregivers of children and assent of children aged >6 years in their language of
understanding.
After enrolment, Children will be randomised to receive cryotherapy or no cryotherapy. at the
time of first enrolment (before giving first dose of high-dose methotrexate). Allocation
concealment will be done by sealed envelope technique and randomisation will be done using
a random allocation software(www.randomizer.org). Individual patient will be alternated to
receive cryotherapy or no cryotherapy during subsequent courses of high dose methotrexate.
The children in the cryotherapy group will be instructed to cool their mouths by keeping ice
popsicles for as long as possible but for minimum of 30 mins every 6 hours in 24 hr
methotrexate infusion period.The popsicles will be made in hospital by pouring mineral water in plastic moulds of ice
popsicles and glucon-d or tang will be added as a flavouring agent. The moulds will then be
kept in the refrigerator(freezer) of the ward and will be ready after 5 hours following which it
will be served to the children of treatment group for cooling their mouth every 6hrs for 30 mins
during the 24-hr high dose methotrexate chemotherapy infusion.
During Oral cryotherapy session, duration will be recorded by the investigator and Patient will
be monitored for development of oral mucositis after completion of 24hr high dose
methotrexate chemotherapy infusion and in case it develops it will be graded using the WHOOral Toxicity Scale by investigator and Parents or Caregivers of Children will be asked to
record symptoms of oral mucositis by using the Children’s International Mucositis Evaluation
Scale (ChIMES. Patients will be asked to maintain a diary after discharge of any symptoms of oral mucositis
and will be told to call up the investigator in case of any symptoms
When the patient comes for subsequent high dose methotrexate chemotherapy, they will be
reviewed for symptoms of oral mucositis.
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
- 2.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Children (aged 2 to 18 years) suffering from acute lymphoblastic leukemia, who are due for high-dose methotrexate therapy.
排除标准
- •1.Children who are not co-operative 2.Children suffering from kidney disease or having deranged Kidney Function Test.
- •3.Children having pre-existing Oral mucositis or Oral Aphthous ulcer.
结局指标
主要结局
Percentage of children with ALL who developed oral mucositis in oral
时间窗: Investigator will check for signs of oral mucositis after 24 hr methotrexate infusion is over and when the patient comes for subsequent high dose methotrexate infusion after 2 weeks. Patient will also be asked to inform the investigator if any symptoms of oral mucositis occur during the 2 week interval between 2 subsequent doses
cryotherapy group v/s no oral cryotherapy group.
时间窗: Investigator will check for signs of oral mucositis after 24 hr methotrexate infusion is over and when the patient comes for subsequent high dose methotrexate infusion after 2 weeks. Patient will also be asked to inform the investigator if any symptoms of oral mucositis occur during the 2 week interval between 2 subsequent doses
次要结局
- The severity of oral mucositis with and without Oral cryotherapy in terms of((a) WHO grading of Oral mucositis And CHIMES Scale,)
研究者
Dr Sampada Anil Kumar kaul
ABVIMS AND DR. RML HOSPITAL NEW DELHI