| CTRI Number |
CTRI/2024/10/075050 [Registered on: 10/10/2024] Trial Registered Prospectively |
| Last Modified On: |
08/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to assess the nutrition, physical activity and health concerns in survivors of childhood cancer who are now adults |
|
Scientific Title of Study
|
Nutritional Status, Dietary Patterns, Physical Activity and Adverse Health Outcomes in Adult Survivors of Childhood Cancer |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 4486 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Maya Prasad |
| Designation |
Professor Paediatric Oncology |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Pediatric Oncology, OPD 80, Ground floor Main building Tata Memorial Hospital Dr. E Borges Road.
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02269537204 |
| Fax |
|
| Email |
prasadm@tmc.gov.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Maya Prasad |
| Designation |
Professor Paediatric Oncology |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Pediatric Oncology, OPD 80, Ground floor Main building Tata Memorial Hospital Dr. E Borges Road.
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02269537204 |
| Fax |
|
| Email |
prasadm@tmc.gov.in |
|
Details of Contact Person
Public Query
|
| Name |
Ms Krisha Savla |
| Designation |
Research Dietitian |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Pediatric Oncology, OPD 80, Ground floor Main building Tata Memorial Hospital Dr. E Borges Road, Parel.
Mumbai
MAHARASHTRA
400012
India |
| Phone |
0226953730 |
| Fax |
|
| Email |
krisha.savla97@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Hospital, Dr E Borges Marg, Parel East, Mumbai 400012 |
|
|
Primary Sponsor
|
| Name |
Dr Maya Prasad |
| Address |
Department of Pediatric Oncology, OPD 80, Tata Memorial Hospital, Dr E Borges Marg, Parel East, Mumbai 400012 |
| Type of Sponsor |
Other [Self] |
|
|
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 Rekha Battalwar |
Sir Vithaldas Thackersey College of Home Science, Mumbai |
S.N.D.T Womens University,
Conference room, Department of Food, Nutrition and Dietetics, Home Science Division , Juhu Tara Rd, Santacruz, Mumbai. 400049
Mumbai
MAHARASHTRA |
02226602504
rekha.battalwar@svt.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee-II, IEC Ofiice, Dr E Borges Marg, Parel East, Mumbai 400012 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Not applicable |
Not applicable |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1. All children treated for cancer at Tata Memorial Hospital, Mumbai, are at least 5 years from diagnosis and have completed treatment and are currently in remission for at least 2 years.
2. Those who have received chemotherapy and/or cranial or whole abdominal radiation therapy
3. Currently aged more than 18 years
4. Less than18 years of age at the time of diagnosis and starting treatment
5. Consenting to be included in the study
|
|
| ExclusionCriteria |
| Details |
1)Survivors treated (partially or completely) at centers other than TMH.
2) Survivors whose treatment details are unavailable.
3) Those with severe neurocognitive or physical impairment unable to give accurate response to diet/physical.
activity/quality of life assessments. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The prevalence of sarcopenic obesity in adult survivors of child cancer using DeXA scan |
The assessments will be conducted after obtaining the consent of the study, in the same visit in After Completion Therapy clinic (ACT Clinic). The standard assessment at each visit and the additional study assessments will be done once after consent is obtained. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. The proportion of survivors vs siblings complying with dietary & physical activity
recommendations as laid down by the WCRF/AICR recommendations.
2. The proportion of obese vs non-obese survivors with adverse health outcomes (diabetes
mellitus, hypertension, pre-hypertension, dyslipidemia, metabolic syndrome, subsequent
neoplasms, frailty, pre-frailty, exercise intolerance, moderate- severe disability on healthrelated quality of life) |
The assessments will be conducted after obtaining the consent of the study, in the same visit in After Completion Therapy clinic (ACT Clinic). The standard assessment at each visit & the additional study assessments will be done once after consent is obtained. |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
21/10/2024 |
| 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="3"
Months="0"
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
|
Childhood cancer survivors also commonly experience obesity, changes in body composition, and metabolic syndrome, which increases their risk of cardiovascular disease. Factors contributing to these issues include the type of cancer treatment received, poor dietary habits, lack of physical activity, and alterations in hormones and inflammation markers.
Despite guidelines recommending healthy lifestyles for cancer survivors, many childhood cancer survivors struggle to adhere to them. However, adopting healthier habits, including better nutrition and increased physical activity, can help prevent or delay the onset of chronic conditions like metabolic syndrome and cardiovascular disease.
Identifying biomarkers and biological mechanisms associated with these conditions could aid in developing prevention strategies. Precise measures of body composition, such as dual-energy X-ray absorptiometry (DXA) and bioelectrical impedance analysis (BIA), are essential for evaluating obesity and its associated risks accurately.
This study aims to investigate sarcopenic obesity prevalence and related factors in adult survivors of childhood cancer at Tata Memorial Hospital (TMH). The hypothesis suggests that Indian survivors may have higher sarcopenic obesity rates and suboptimal dietary and physical activity patterns compared to the general population, leading to adverse metabolic changes. |