| CTRI Number |
CTRI/2025/06/088815 [Registered on: 13/06/2025] Trial Registered Prospectively |
| Last Modified On: |
13/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study to determine effect of cisplatin causing acute and chronic kidney damage in head and neck and cervix cancer patients during radiation treatment |
|
Scientific Title of Study
|
Assessment of severity and risk factors for nephrotoxicity in Head & Neck and Cervix carcinoma patients on cisplatin based chemoradiation |
| 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 Shubhada Agarwal |
| Designation |
Junior Resident |
| Affiliation |
JIPMER |
| Address |
Office of Radiation oncology, ground floor,Department of Radiation Oncology, Regional Cancer Centre, JIPMER
Gorimedu, Pondicherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9834483879 |
| Fax |
|
| Email |
iamshubhadathesis@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pooja Sethi |
| Designation |
Associate Professor |
| Affiliation |
JIPMER |
| Address |
Office of Radiation oncology, ground floor,Department of Radiation Oncology, Regional Cancer Centre, JIPMER
Gorimedu, Pondicherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9543601257 |
| Fax |
|
| Email |
docpujasethi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pooja Sethi |
| Designation |
Associate Professor |
| Affiliation |
JIPMER |
| Address |
Office of Radiation oncology, ground floor, Department of Radiation Oncology, Regional Cancer Centre, JIPMER
Gorimedu, Pondicherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9543601257 |
| Fax |
|
| Email |
docpujasethi@gmail.com |
|
|
Source of Monetary or Material Support
|
| JIPMER, Pondicherry 605006 |
|
|
Primary Sponsor
|
| Name |
Dr Shubhada Agarwal |
| Address |
Regional cancer center, JIPMER, Pondicherry 605006 |
| 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 Shubhada Agarwal |
Jawaharlal Institute of Medical Education and Research JIPMER |
Office of Radiation oncology, ground floor,Department of Radiation Oncology, Regional Cancer Centre, JIPMER
Gorimedu, Pondicherry
Pondicherry
PONDICHERRY |
09834483879
iamshubhadathesis@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C539||Malignant neoplasm of cervix uteri, unspecified, (2) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Age more than 18 years, histologically confirmed squamous/Adeno/adeno-squamous cell carcinoma of Head and Neck or Cervix region, planned for radical or adjuvant chemoradiation with concurrent cisplatin based weekly or 3 weekly chemotherapy |
|
| ExclusionCriteria |
| Details |
Prior renal irradiation
Creatinine clearance less than 45 ml/min
Patients who did not give consent for study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the incidence and severity of nephrotoxicity in Head and Neck and Cervical carcinoma patients on concurrent cisplatin based chemoradiation |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine the risk factors for acute kidney injury (as per KDIGO Criteria)
|
3 months |
To determine the risk factors for chronic kidney disease (as per KDIGO Criteria)
|
3 months |
To explore the feasibility of developing risk prediction model based on above observations
|
3 months |
|
|
Target Sample Size
|
Total Sample Size="271"
Sample Size from India="271"
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)
|
24/06/2025 |
| 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) |
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
|
All eligible and consenting patients meeting the inclusion criteria will be enrolled in the study, which aims to assess the incidence and severity of nephrotoxicity in patients with head and neck or cervical carcinoma undergoing concurrent cisplatin-based chemoradiation. Baseline assessments will include demographics (age, BMI, comorbidities, medications, substance use, ECOG status), cancer-related parameters (site, stage, treatment intent, morbidities), routine blood investigations, and GFR estimation using Technetium-99m DTPA plasma clearance, with blood samples drawn at 60 and 180 minutes post-injection. During chemoradiation, detailed records will be maintained on chemotherapy and radiotherapy regimens, hydration, antiemetics, cisplatin dosing, weekly renal monitoring, CTCAE v5-graded toxicities, hospitalizations, and supportive interventions (e.g., feeding tubes, pain control). At one and three months post-treatment, renal function will be reassessed using serum creatinine and repeat DTPA-based GFR estimation. The study further aims to determine risk factors for acute kidney injury (AKI) and chronic kidney disease (CKD) as per KDIGO criteria, and to explore the feasibility of developing a risk prediction model based on the collected data |