| CTRI Number |
CTRI/2022/09/045847 [Registered on: 26/09/2022] Trial Registered Prospectively |
| Last Modified On: |
23/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
longitudinal study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Studying of Peripheral Neuropathy, Fatigue and Sarcopenia in Children with Acute Lymphoblastic Leukemia (ALL) and Lymphoma |
|
Scientific Title of Study
|
Evaluation of Chemotherapy-Induced Peripheral Neuropathy, Sarcopenia, and
Fatigue in Children with Acute Lymphoblastic Leukemia and Lymphoma in Maintenance Phase. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nishtha Manoj Singhal |
| Designation |
Post Graduate Student |
| Affiliation |
Kasturba Medical College, Mangalore |
| Address |
Department of Physiotherapy, KMC Mangalore, Centre for Basic Sciences, Bejai, Mangaluru
Dakshina Kannada
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
|
| Fax |
|
| Email |
nsinghal016@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Stephen Rajan Samuel |
| Designation |
MPT, Ph.D, Assistant professor Senior scale |
| Affiliation |
Kasturba Medical College, Mangalore |
| Address |
Department of Physiotherapy, KMC Mangalore, Centre for Basic Sciences, Bejai, Mangaluru
Dakshina Kannada
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
|
| Fax |
|
| Email |
stephen.samuel@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Nishtha Manoj Singhal |
| Designation |
Post Graduate Student |
| Affiliation |
Kasturba Medical College, Mangalore |
| Address |
Department of Physiotherapy, KMC Mangalore, Centre for Basic Sciences, Bejai, Mangaluru
Dakshina Kannada
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
|
| Fax |
|
| Email |
nsinghal016@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of physiotherapy, KMC Hospital, Attavar Dakshina Kannada KARNATAKA |
|
|
Primary Sponsor
|
| Name |
Manipal Academy of Higher Education |
| Address |
Lighthouse hill road, Mangalore - 575001 |
| Type of Sponsor |
Private 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 |
| Nishtha Manoj Singhal |
KMC Hospital, Mangalore |
Department of Physiotherapy, KMC Mangalore,2nd floor, KMC Hospital, Attavar
Dakshina Kannada
KARNATAKA |
7022791045
nsinghal016@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Kasturba Medical College, Mangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C910||Acute lymphoblastic leukemia [ALL], |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Children of 5-18 years during maintenance phase with Acute Lymphoblastic Leukemia and Lymphoma receiving chemotherapy. The ECOG score <2 will be included. |
|
| ExclusionCriteria |
| Details |
1. Participants with severe orthopedic and neurological dysfunctions that may limit them
from participating in the study.
2. Participants with Metastasis.
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Severity of side effects of chemotherapy |
3-Time points, i.e., at start of maintenance phase, at 3 months and and at 6 months of maintenance phase |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Help in evaluating the overall quality of life of children through physical performance, fatigue and sarcopenia assessment. |
3-Time points, i.e., at start of maintenance phase, at 3 months and and at 6 months of maintenance phase |
|
|
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)
|
26/09/2022 |
| 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="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
To evaluate the magnitude of chemotherapy induced peripheral neuropathy, fatigue and sarcopenia in children with Acute lymphoblastic leukaemia and Lymphoma during the maintenance phase. |