| CTRI Number |
CTRI/2025/07/092036 [Registered on: 30/07/2025] Trial Registered Prospectively |
| Last Modified On: |
30/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Other (Specify) [Supplementation vitamin in the form glutamine sachets] |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Study comparing glutamine supplement to reduce mouth sores in children with blood cancer undergoing chemotherapy |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
P Manasa |
| Designation |
MDS student |
| Affiliation |
Government Dental College and Hospital Vijayawada |
| Address |
Government Dental College and Hospital ESI road Gunadala Vijayawada krishna district
Government Dental College and Hospital ESI road Gunadala Vijayawada krishna district
Krishna
ANDHRA PRADESH
520004
India |
| Phone |
07981717816 |
| Fax |
|
| Email |
pujarimanasa97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
G Jesudass |
| Designation |
Professor & HOD |
| Affiliation |
Government Dental College and Hospital Vijayawada |
| Address |
Government Dental College and Hospital ESI road Gunadala Vijayawada krishna district
Krishna
ANDHRA PRADESH
520004
India |
| Phone |
9618810707 |
| Fax |
|
| Email |
jesudass.govada@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
P Manasa |
| Designation |
MDS student |
| Affiliation |
Government Dental College and Hospital Vijayawada |
| Address |
Government Dental College and Hospital ESI road Gunadala Vijayawada krishna district
Krishna
ANDHRA PRADESH
520004
India |
| Phone |
07981717816 |
| Fax |
|
| Email |
pujarimanasa97@gmail.com |
|
|
Source of Monetary or Material Support
|
| Multidisciplinary research unit (MRU), Sidhartha medical college & Hospital, NH 16 Service Rd, Beside Dr NTR University of Health Sciences, Gunadala, Vijayawada, Andhra Pradesh 520008 India |
|
|
Primary Sponsor
|
| Name |
Siddhartha Medical College , Vijayawada |
| Address |
Siddhartha Medical College , Gunadala, Vijayawada, krishna dist, 520004 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Manasa Pujari |
1 HCG curie city Cancer Hospital 2 Siddhartha medical college & Hospital |
1 Oncology departement Padavalarevu gunadala Vijayawada Krishna district Andhra pradesh 520008 India
2 Multidisciplinary research unit MRU Biochemistry department ESI road Gunadala Vijayawada krishna district Andhra Pradesh 520008 India
Krishna
ANDHRA PRADESH |
07981717816
pujarimanasa97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Instituitional Ethics Committee Siddhartha Medical College & Govt. General Hospital (IEC SMC & GGH) |
Approved |
| Institutional ethics committee GDC&H |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D728||Other specified disorders of whiteblood cells, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Oncoglute powder |
Oncoglute powder 15g which contains L-Glutamine, Vitamin A, Vitamin C, Vitamin E with selenium will be given daily one sachet for 5 days |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
age group morethan 15 years
Children without Acute lymphoblastic leukemia |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To reduce the severity of oral mucositis in chemotherapy patients with ALL |
The outcome will be assessed in 3 weeks after the supplementation of glutamine |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improves nutritional value & have proper appetite |
The nutritional value improvement can be seen after the reduction of mucositis (after 3 weeks ) |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
16/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
- 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. |