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临床试验/CTRI/2025/07/092036
CTRI/2025/07/092036尚未招募2/3 期

Comparative evaluation of efficacy of Glutamine supplementation in management of oral mucositis before and during chemotherapy in children with Acute Lymphoblastic Leukemia (ALL)- An Invivo study

Siddhartha Medical College , Vijayawada1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年8月16日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
To reduce the severity of oral mucositis in chemotherapy patients with ALL

研究概览

简要总结

  • Leukemia is most common underlying malignant disease in children, characterized by differentiation and proliferation of immature leukocytes.
  • Among different types of leukemia , ALL (Acute Lymphoblastic Leukemia ) is most common childhood cancer.
  • Chemotherapy is one of the treatment modalities of Leukemia with high probability in  treating cancer. However , it has undesirable effects of affecting normal tissues , one of which is oral mucosa.
  • Oral complication resulting from Chemotherapeutic treatment is onset of inflammation and ulceration of oral mucosa (ORAL MUCOSITIS)
  • Clinically manifests in an edematous, erythematous and friable form, resulting in pain, discomfort ,dysphagia and systemic weakness.
  • Delays chemotherapy , extend treatment days , affect the quality of life, jeopardizes the success of cancer therapy, thereby increasing overall treatment costs
  • To address these challenges , effective treatment management is required , aiming to alleviate symptoms . One of the treatment modality is found to be Glutamine according to the literature which appears to be safe and appropriate  for treating oral mucositis in children with cancer.

Group 1: Glutamine supplementation given to (50%) children with Acute Lymphoblastic leukemia before chemotherapy

Group 2: Glutamine supplementation given to (50%) children with Acute Lymphoblastic Leukemia during chemotherapy with oral mucositis

METHODOLOGY:

•Two groups will be included with age group in between 2 to 15 years.

•Initially assessing the oral mucosa for oral mucositis by using WHO scale.

•Blood samples are drawn as a part of treatment for routine investigation, from which 20 to 25 microlitre of blood will be collected, transported through vaccine carrier with gel pack in it and sent to lab within 24hrs for assessing glutamine levels using calorimetric method/ ELISA method.

•Glutamine supplements will be administered orally in group I patients. Follow up will be done for assessing severity of oral mucositis by using WHO scale

•Glutamine supplements will be administered orally to patients undergoing chemotherapy with methotrexate in group II. Follow up will be done to assess the severity of oral mucositis

•Glutamine administration will be done under the consultation of Pediatrician or Hemato-Oncologist.

研究设计

研究类型
Interventional
分配方式
Na
盲法
Participant Blinded

入排标准

年龄范围
2.00 Year(s) 至 15.00 Year(s)(—)
性别
All

入选标准

  • Age group- 2 to 14 years Children with Acute lymphoblastic leukemia (ALL) Children with ALL before chemotherapy treatment Children with ALL undergoing chemotherapy Children with Oral Mucositis Subject Parent willingness.

排除标准

  • age group morethan 15 years Children without Acute lymphoblastic leukemia.

结局指标

主要结局

To reduce the severity of oral mucositis in chemotherapy patients with ALL

时间窗: The outcome will be assessed in 3 weeks after the supplementation of glutamine

次要结局

  • Improves nutritional value & have proper appetite(The nutritional value improvement can be seen after the reduction of mucositis (after 3 weeks ))

研究者

发起方
Siddhartha Medical College , Vijayawada
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

P Manasa

Government Dental College and Hospital Vijayawada

研究点 (1)

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