| CTRI Number |
CTRI/2019/11/022181 [Registered on: 27/11/2019] Trial Registered Prospectively |
| Last Modified On: |
20/05/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Body composition assessment in children with Acute Lymphoblastic Leukaemia (ALL) during cancer treatment |
|
Scientific Title of Study
|
Accurate estimation of changes in body composition, energy balance and nutritional status of Indian children with Acute Lymphoblastic Leukaemia (ALL) during cancer treatment |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 236/2019 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Tony D S Raj |
| Designation |
Dean, Professor |
| Affiliation |
St John s Research Institute |
| Address |
Professor of Physiology St John s Medical College,
Head, Division of Medical Informatics,
Dean s Office, St John s Research Institute,
St John s National Academy of Health Sciences
Koramangala
Bangalore
KARNATAKA
560034
India |
| Phone |
08049467000 |
| Fax |
|
| Email |
tonyraj@sjri.res.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tony D S Raj |
| Designation |
Dean, Professor |
| Affiliation |
St John s Research Institute |
| Address |
Professor of Physiology St John s Medical College,
Head, Division of Medical Informatics,
Dean s Office, St John s Research Institute,
St John s National Academy of Health Sciences
Koramangala
Bangalore
KARNATAKA
560034
India |
| Phone |
08049467000 |
| Fax |
|
| Email |
tonyraj@sjri.res.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tony D S Raj |
| Designation |
Dean, Professor |
| Affiliation |
St John s Research Institute |
| Address |
Professor of Physiology St John s Medical College,
Head, Division of Medical Informatics,
Dean s Office, St John s Research Institute,
St John s National Academy of Health Sciences
Koramangala
Bangalore
KARNATAKA
560034
India |
| Phone |
08049467000 |
| Fax |
|
| Email |
tonyraj@sjri.res.in |
|
|
Source of Monetary or Material Support
|
| International Atomic Energy Agency
Vienna International Centre
PO Box 100
1400 Vienna, Austria
Tel (431) 26000
Fax (431) 26007 |
|
|
Primary Sponsor
|
| Name |
International Atomic Energy Agency |
| Address |
Vienna International Centre
PO Box 100
1400 Vienna
Austria |
| Type of Sponsor |
Other [Intergovernmental forum for scientific and technical co-operation in the nuclear field] |
|
|
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 Tony D S Raj |
St John s Research Institute |
Division of Nutrition, Body composition lab, SJRI Admin Block, St John s Research Institute
St Johns National Academy of Health Sciences
John Nagar
Koramangala
Bangalore
KARNATAKA |
08049467000
tonyraj@sjri.res.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| St John s Medical College Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Normal healthy children as controls in the age of 2-10 years |
| Patients |
(1) ICD-10 Condition: C910||Acute lymphoblastic leukemia [ALL], |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
Inclusion Criteria
Modification(s)
|
| Age From |
2.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Newly detected cases of children with acute lymphoblastic leukaemia
Age range 2 to 10 years
Normal healthy children in the age of 2 to 10 as control subjects
|
|
| ExclusionCriteria |
| Details |
Conditions such as diabetes, hormonal problems which could affect body composition
Children with sepsis causing hemodynamic compromise and who cannot be assessed.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Novel data providing accurate body composition measurements (BCM and Fat) at baseline along with data on the changes occurring in body composition in children with ALL in India.
|
End of treatment phase
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Data on the dietary intake, physical activity and energy expenditure of children with ALL which will provide insights into the possible reasons for observed energy imbalance
|
End of treatment phase |
| Assessment of frailty in children with ALL during treatment |
End of treatment phase |
| A predictive equation for BCM from simple anthropometric measurements that can be used widely. |
End of treatment phase |
| Estimates of hydration and density of FFM in children with ALL. |
End of treatment phase |
| Information that can be used by professionals to tailor nutritional intervention and ensure the best outcome in oncology patients. |
End of treatment phase |
|
Target Sample Size
Modification(s)
|
Total Sample Size="58"
Sample Size from India="58"
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
|
N/A |
|
Date of First Enrollment (India)
|
22/09/2020 |
| 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
Modification(s)
|
Years="7"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The incidence of paediatric cancer is on the rise with the global prevalence being 14.9 per million. Acute Lymphoblastic Leukemia (ALL) is the most common childhood cancer and these children have increased complications during the treatment leading to poor nutritional status and reduced quality of life. The aim of the proposed study is to accurately measure the body composition (body cell mass and fat mass) of children with ALL at diagnosis and during the various stages of chemotherapy & to evaluate the role of diet and physical activity. The findings of the proposed study will provide novel baseline information on the body composition in Indian children with ALL, along with data on the changes occurring in body composition and energy balance during treatment. The data on energy intake and expenditure will provide insights into the possible reasons for energy imbalance. The proposed study, for the first time will provide data on the composition of fat free mass (FFM) in children with ALL and estimates of the changes in the composition of FFM during treatment in Indian children. These findings will have clinical relevance in the management of fast mass gain in ALL survivors |