| CTRI Number |
CTRI/2017/08/009567 [Registered on: 31/08/2017] Trial Registered Retrospectively |
| Last Modified On: |
12/06/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
prospective clinical trial |
| Study Design |
Other |
|
Public Title of Study
|
dietary advice effect on pediatric cancer patient |
|
Scientific Title of Study
|
Effect of dietary advice on nutritional status in pediatric cancer patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrBiswajit Dubashi |
| Designation |
Associate professor |
| Affiliation |
Jawaharlal institute of postgraduate medical education and research |
| Address |
Department of medical oncology Regional cancer centre
JIPMER
Danvanthri nagar Gorimedu
Department of medical oncology Regional cancer centre
Room number 13
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8056338405 |
| Fax |
8056338405 |
| Email |
drbiswajitdm@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrBiswajit Dubashi |
| Designation |
Associate professor |
| Affiliation |
Jawaharlal institute of postgraduate medical education and research |
| Address |
Department of medical oncology Regional cancer centre
JIPMER Danvanthri nagar Gorimedu
Department of medical oncology Regional cancer centre
Room number 13
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8056338405 |
| Fax |
8056338405 |
| Email |
drbiswajitdm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrBiswajit Dubashi |
| Designation |
Associate professor |
| Affiliation |
Jawaharlal institute of postgraduate medical education and research |
| Address |
Department of medical oncology Regional cancer centre
JIPMER Danvanthri nagar Gorimedu
Department of medical oncology Regional cancer centre
Room number 13
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8056338405 |
| Fax |
8056338405 |
| Email |
drbiswajitdm@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal institute of postgraduate medical education and research, Department of medical oncology,Regional cancer centre,
Danvanthri nagar Gorimedu,ponducherry-605006
|
|
|
Primary Sponsor
|
| Name |
not applicable |
| Address |
not applicable |
| Type of Sponsor |
Other [not applicable] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| not applicable |
not applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Biswajit Dubashi |
Jawaharlal institute of postgraduate medical education and research |
Medical oncology, Regional cancer centre
Room number 13
Pondicherry
PONDICHERRY |
8056338405
drbiswajitdm@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institute ethics committee(human studies)jipmer |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
pediatric cancer, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
newly diagnosed cancer patients <18 years
patients on chemotherapy |
|
| ExclusionCriteria |
| Details |
children receiving only radiotherapy
children undergone only surgery
children with previous history of chemotherapy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| improvement in nutritional status |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| quick respose to treatment , reduced infection and positive disease outcomes |
6 months |
|
|
Target Sample Size
|
Total Sample Size="125"
Sample Size from India="125"
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)
|
22/11/2016 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
1. Iniesta RR, Paciarotti I, Brougham MF, McKenzie JM, Wilson DC. Effects of pediatric cancer and its treatment on nutritional status: a systematic review. Nutr Rev. 2015; 73:276-95.
2. Murphy AJ, White M, Davies PS. Body composition of children with cancer. Am J Clin Nutr. 2010; 92:55-60.(4)
3. Elhasid R, Laor A, Lischinsky S, Postovsky S, Weyl Ben Arush M. Nutritional status of children with solid tumors. Cancer. 1999: 1; 86:119-25. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study provides a baseline data on nutritional status and effects of nutritional advice on nutritional status,infection and disease outcome in pediatric cancer patients. In this study nutritional status of children are assessed on baseline and dietary advice are given. Periodical evaluation on the nutritional status will be done to find out the effect of nutritional advice on the children nutritional status. |