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CTRI Number  CTRI/2024/04/066130 [Registered on: 23/04/2024] Trial Registered Prospectively
Last Modified On: 20/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive 
Study Design  Randomized, Crossover Trial 
Public Title of Study   Ice popsicles for prevention of oral ulcer following anti-cancer therapy in children suffering from blood cancer. 
Scientific Title of Study   Oral Cryotherapy for prevention of Oral mucositis following high dose methotrexate in children with Acute Lymphoblastic Leukemia: A Randomised controlled 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  Dr Sampada Anil Kumar kaul  
Designation  Post graduate resident  
Affiliation  ABVIMS AND DR. RML HOSPITAL NEW DELHI  
Address  New Emergency services building (3rd floor) Unit P3B .Department of Paediatrics, ABVIMS and Dr. RML HOSPITAL, NEW DELHI 110001

New Delhi
DELHI
110001
India 
Phone  9665854445  
Fax    
Email  sampadakaul@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shilpa Khanna Arora  
Designation  Professor  
Affiliation  ABVIMS and Dr RML HOSPITAL NEW DELHI  
Address  New Emergency services building (3rd floor). Dept of paediatrics ABVIMS and Dr RML HOSPITAL NEW DELHI
ABVIMS and Dr RML HOSPITAL NEW DELHI baba kharak singh marg
New Delhi
DELHI
110001
India 
Phone  9310112085  
Fax    
Email  drshilpakhanna@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Sampada Anil Kumar kaul  
Designation  Post graduate resident  
Affiliation  ABVIMS and Dr RML HOSPITAL  
Address  New Emergency services building (3rd floor) Unit P3B Dr.RML Hospital New Delhi.

New Delhi
DELHI
110001
India 
Phone  9665854445  
Fax    
Email  sampadakaul@gmail.com  
 
Source of Monetary or Material Support  
ABVIMS AND DR RML HOSPITAL Baba kharak Singh marg NEW DELHI , INDIA, PINCODE-110001 
 
Primary Sponsor  
Name  Nil 
Address  Nil 
Type of Sponsor  Other [Nil] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr sampada anil kumar kaul  ABVIMS & Dr RML Hospital NEW DELHI   New Emergency services building (3rd floor). Department of Paediatrics
New Delhi
DELHI 		 9665854445

sampadakaul@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instituitional Ethics Committee ABVIMS And Dr. RML HOSPITAL NEW DELHI  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C910||Acute lymphoblastic leukemia [ALL],  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  No Cryotherapy   The children in no Cryotherapy group will be alternated with patients in no Cryotherapy group. Out of 4 sessions of receiving high dose methotrexate...each patient will recieve cryotherapy in 2 sessions alternatively and will act as control for themselves in the other 2 sessions. 
Intervention  Oral Cryotherapy  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. 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Children (aged 2 to 18 years) suffering from acute lymphoblastic leukemia, who are
due for high-dose methotrexate therapy. 
 
ExclusionCriteria 
Details  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. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Percentage of children with ALL who developed oral mucositis in oral
cryotherapy group v/s no oral cryotherapy group.
 		 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 
 
Secondary Outcome  
Outcome  TimePoints 
The severity of oral mucositis with and without Oral cryotherapy in terms of
(a) WHO grading of Oral mucositis And CHIMES Scale,
(b) Onset and duration of mucositis (in days).
(c) use of analgesics (whether used or not)
(d) need for hospitalization
• Feasibility
(no. of minutes for which child is able to suck on Ice popsicles in each session
of 24hr chemotherapy duration will be added.) 		 The severity of oral mucositis with and without Oral cryotherapy in terms of
(a) WHO grading of Oral mucositis And CHIMES Scale,
(b) Onset and duration of mucositis (in days).
(c) use of analgesics (whether used or not)
(d) need for hospitalization
• Feasibility
(no. of minutes for which child is able to suck on Ice popsicles in each session
of 24hr chemotherapy duration will be added.) 
 
Target Sample Size   Total Sample Size="42"
Sample Size from India="42" 
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)   15/05/2024 
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="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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   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.
 
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