| CTRI Number |
CTRI/2024/08/072672 [Registered on: 19/08/2024] Trial Registered Prospectively |
| Last Modified On: |
21/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Use of steroids in cancer treatment causing Diabetes Mellitus |
|
Scientific Title of Study
|
Steroid induced Diabetes Mellitus in Cancer patients due to use of Dexamethasone as premedication for chemotherapy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ruhi Kumar |
| Designation |
DM Medical Oncology Resident |
| Affiliation |
Stanley Medical College |
| Address |
No.53 OPD, Ground floor, Super Specialty Block, Govt Stanley Medical College, Chennai
No.1, Old Jail Road, Old Washermanpet, Royapuram, George Town
Chennai
TAMIL NADU
600001
India |
| Phone |
9008765436 |
| Fax |
|
| Email |
ruhikmbbs@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PN Sathiyamoorthy |
| Designation |
Associate Professor |
| Affiliation |
Stanley Medical College |
| Address |
No.53 OPD, Department of Medical Oncology, Ground floor, Super Specialty Block, Govt Stanley Medical College, Chennai
No.1, Old Jail Road, Old Washermanpet, Royapuram, George Town
Chennai
TAMIL NADU
600001
India |
| Phone |
|
| Fax |
|
| Email |
medicaloncology_gsh@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Ruhi Kumar |
| Designation |
DM Medical Oncology Resident |
| Affiliation |
Stanley Medical College |
| Address |
No.53 OPD, Department of Medical Oncology, Ground floor, Super Specialty Block, Govt Stanley Medical College, Chennai
No.1, Old Jail Road, Old Washermanpet, Royapuram, George Town
TAMIL NADU
600001
India |
| Phone |
9008765436 |
| Fax |
|
| Email |
ruhikmbbs@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Govt. Stanley Medical College, No.1, Old Jail Road, Old Washermanpet, Royapuram, George Town, Chennai, Tamil Nadu, India-600001 |
|
|
Primary Sponsor
|
| Name |
Govt Stanley Medical College |
| Address |
No.1, Old Jail Road, Old Washermanpet, Royapuram, George Town, Chennai, Tamil Nadu, India-600001 |
| 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 Ruhi Kumar |
Govt Stanley medical college |
No.53 OPD, Department of Medical Oncology, Ground floor, Super Specialty Block.
Chennai
TAMIL NADU |
9008765436
ruhikmbbs@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Govt Stanley Medical College Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, (2) ICD-10 Condition: C189||Malignant neoplasm of colon, unspecified, (3) ICD-10 Condition: C169||Malignant neoplasm of stomach, unspecified, (4) ICD-10 Condition: C23||Malignant neoplasm of gallbladder, (5) ICD-10 Condition: C259||Malignant neoplasm of pancreas, unspecified, (6) ICD-10 Condition: C349||Malignant neoplasm of unspecifiedpart of bronchus or lung, (7) ICD-10 Condition: C569||Malignant neoplasm of unspecifiedovary, (8) ICD-10 Condition: C61||Malignant neoplasm of prostate, (9) ICD-10 Condition: C679||Malignant neoplasm of bladder, unspecified, (10) ICD-10 Condition: C819||Hodgkin lymphoma, unspecified, (11) ICD-10 Condition: C829||Follicular lymphoma, unspecified, (12) ICD-10 Condition: C839||Non-follicular (diffuse) lymphoma,unspecified, (13) ICD-10 Condition: C859||Non-Hodgkin lymphoma, unspecified, (14) ICD-10 Condition: C499||Malignant neoplasm of connective and soft tissue, unspecified, (15) ICD-10 Condition: C19||Malignant neoplasm of rectosigmoidjunction, (16) ICD-10 Condition: C218||Malignant neoplasm of overlappingsites of rectum, anus and anal canal, (17) ICD-10 Condition: C20||Malignant neoplasm of rectum, (18) ICD-10 Condition: C249||Malignant neoplasm of biliary tract, unspecified, (19) ICD-10 Condition: C221||Intrahepatic bile duct carcinoma, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Cancer patients receiving dexamethasone as premedication for chemotherapy |
|
| ExclusionCriteria |
| Details |
Known diabetics or newly detected diabetes mellitus defined as FBS >126 mg/dL, RBS >200 mg/dL or HbA1c >6.5% at baseline testing |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Patients who become newly detected diabetes mellitus defined as FBS more than or equal to 126 mg/dL or HbA1c more than or equal to 6.5% |
Fasting blood glucose, Post prandial blood glucose and HbA1c will be checked at 3 months and 6 months after start of dexamethasone. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Fasting insulin levels will be studied & insulin resistance will be calculated by HOMA-IR formula. High insulin resistance will be defined by HOMA-IR more than or equal to 2.5. |
Fasting insulin levels will be studied at baseline, before start of dexamethasone & at 3 months & 6 months after starting dexamethasone. |
| Patient reported outcome of chemotherapy induced nausea & vomiting will be recorded using the FLIE questionnaire. |
The questionnaire will be administered at baseline, then at the beginning of every cycle for 6 to 8 cycles of chemotherapy as per patient treatment protocol. |
| Patients who become newly detected diabetes mellitus defined as FBS more than or equal to 126 mg/dL or HbA1c more than or equal to 6.5% |
Patients who complete their treatment & remain steroid free for 6 months after completion of treatment will undergo fasting blood glucose, post prandial blood glucose, fasting insulin level & HbA1c testing at 12 months after enrollment. |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
01/09/2024 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This study is being conducted as proof of concept to use dexamethasone or other steroid free regimens in premedication of chemotherapy in cancer patients. It will be carried out in non diabetic patients to study the incidence of diabetes mellitus in patients receiving steroids a premedication of chemotherapy. It will also study the effect of steroids on insulin resistance, long term-effect of steroids on diabetes mellitus and patient reported outcomes of chemotherapy induced nausea and vomiting. |