Study to determine effect of cisplatin causing acute and chronic kidney damage in head and neck and cervix cancer patients during radiation treatment

Not yet recruiting

Conditions: Malignant neoplasm of cervix uteri, unspecified, (2) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx,

Registration Number: CTRI/2025/06/088815

Lead Sponsor: Dr Shubhada Agarwal

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

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 271

Inclusion Criteria

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.

Exclusion Criteria

Prior renal irradiation Creatinine clearance less than 45 ml/min Patients who did not give consent for study.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
To determine the risk factors for acute kidney injury (as per KDIGO Criteria)
To determine the risk factors for chronic kidney disease (as per KDIGO Criteria)
To explore the feasibility of developing risk prediction model based on above observations

Trial Locations

Locations (1): Jawaharlal Institute of Medical Education and Research JIPMER
🇮🇳
Pondicherry, PONDICHERRY, India
Jawaharlal Institute of Medical Education and Research JIPMER
🇮🇳Pondicherry, PONDICHERRY, India
Dr Shubhada Agarwal
Principal investigator
09834483879
iamshubhadathesis@gmail.com