| CTRI Number |
CTRI/2024/05/066876 [Registered on: 07/05/2024] Trial Registered Prospectively |
| Last Modified On: |
05/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Adverse effects on adrenal gland in cancer patients after chemotherapy |
|
Scientific Title of Study
|
Adrenal insufficiency in children with cancer after chemotherapy |
| 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 Ankita Soni |
| Designation |
Post Graduate resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Ward 15, Department of Paediatrics, Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi
Central
DELHI
110002
India |
| Phone |
9716854227 |
| Fax |
|
| Email |
ANKITASONI29@GMAIL.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aashima Dabas |
| Designation |
Associate Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Maulana Azad Medical College, Bahadur Shah Zafar Marg, near Delhi Gate, New Delhi
Central
DELHI
110002
India |
| Phone |
9868479647 |
| Fax |
|
| Email |
DR.AASHIMAGUPTA@GMAIL.COM |
|
Details of Contact Person
Public Query
|
| Name |
Ankita Soni |
| Designation |
Postgraduate resoident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Ward 15, Department of Pediatrics, Maulana Azad Medical College, Bahadur Shah Zafar Marg, Near Delhi Gate, New Delhi
Central
DELHI
110001
India |
| Phone |
9716854227 |
| Fax |
|
| Email |
ANKITASONI29@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
| Lok Nayak Hospital, Jawaharlal Nehru Marg, near Delhi Gate, New Delhi-110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
Bahadur Shah Zafar Marg, near Delhi Gate, New Delhi, 110002 |
| 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 Ankita Soni |
Maulana Azad Medical College |
Department of Paediatrics
Central
DELHI |
9716854227
ANKITASONI29@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee, Maulana Azad Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D499||Neoplasm of unspecified behavior of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Who Have received chemotherapy for childhood cancer for a minimum of three month period in last two years |
|
| ExclusionCriteria |
| Details |
History of systemic steroid intake in last 3 months, any previous known endocrine disorders, septic shock, febrile neutropenia, critically ill child |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of children with adrenal insufficiency after low dose ACTH stimulation test |
baseline, 60 mins |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Proportion of children with low thyroid stimulating hormone and/or low free thyroxine |
baseline |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
24/05/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
Chemotherapy-related transient Hypothalamo-Pituitary-Adrenal Axis dysfunction is reported
during acute periods of treatment in childhood cancers, but evidence of its permanence is less
known. In earlier study in children with cancer reported low serum cortisol in 52% of patients during
acute febrile illness. Few studies have reported partial recovery of adrenal function after
induction therapy of cancer treatment over a variable period of time. However, evidence of
adrenal insufficiency after the acute period and the need for stress dosing of steroids on
follow-up is lacking. Hence, we plan to estimate the proportion of children with adrenal insufficiency after
chemotherapy for cancer. |