A study to evaluate cisplatin induced hearing loss among patients of head and neck cancers receiving chemoradiation treatment
Not Applicable
- Conditions
- Health Condition 1: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx
- Registration Number
- CTRI/2024/08/072465
- Lead Sponsor
- Sri Venkateshwara Institute of medical sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Head and neck squamous cell carcinomas Stage I – IVb (AJCC Staging 8th Edition) (14) (American joint Committee on Cancer) requiring definitive CRT/ Adjuvant CRT
2. Various sites of HNC including oral cavity, oropharynx nasopharynx & hypopharynx
3. Age : 18 years and above
4. Eastern Cooperative Oncology Group (ECOG)
Performance Status Scale (PSS) – 0-2
5. Patients who have given approval for informed written consent
Exclusion Criteria
•Patients with distant metastasis Stage IV C
•ECOG PSS – 3 - 4
•Previous RT to the head-and-neck region
•Lack of a pre-radiation audiometry
•Patients with Congenital/ acquired hearing loss
•Pregnant and Lactating mothers
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of sensorineural hearing loss by Pure tone AudiometryTimepoint: Day 1 to 3 months after treatment
- Secondary Outcome Measures
Name Time Method To find the correlation between the cumulative dose of cisplatin to the various degrees of SNHL and severity of SNHL at different frequencies. <br/ ><br>Timepoint: Day 1 to 3 months after treatment