STUDY TO ASSESS HEARING LOSS IN PATIENTS RECEIVING CHEMORADIOTHERAPY IN ADJUVANT SETTING FOR HEAD AND NECK MALIGNANCY
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- HEARING LOSS IN DECIBELS ACHIEVED BY PURE TONE AUDIOMETRY
Study Overview
Brief Summary
Head andneck cancers in India account for 30% of all cancers. In India, 60 to 80 % ofpatients present with advanced disease as compared to 40% in developedcountries.Chemoradiotherapy (CTRT) is the most common modalityof treatment for advanced head and neck cancers.
Radiation induced sensorineuralhearing loss (SNHL) is an important side effect as the temporal bone is oftenincluded in the field of radiation.It is usually high frequencySNHL that occurs either during or 6-24 months after therapy and may progress tocomplete deafness. The widely used chemotherapeutic drug, cisplatin, is alsoknown to cause ototoxicity, thus adding to the SNHL.
This hearing impairment can causesignificant disability in these patients especially in cases of binauralhearing loss, hence this should be kept in mind during the pre- radiotherapycounseling and post-radiotherapy follow-up of these patients. Manyof the previous reports were based on studies that were either retrospective orinvolved a limited number of patients. The aim of this study is the qualitativeand quantitative assessment of hearing loss in patients receiving CTRT inadjuvant settings for head and neck malignancy.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 20.00 Year(s) to 80.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •INDIVIDUALS SUFFERING FROM HEAD AND NECK MALIGNANCIES RECEIVING CHEMO-RADIATION FOR THE SAME WITH TEMPORAL BONE IN THE RADIATION FIELD.
- •INDIVIDUALS WILLING FOR TIMED AUDIOLOGICAL ASSESSMENT.
Exclusion Criteria
- •INDIVIDUALS ALREADY SUFFERING FROM PROFOUND HEARING LOSS AND RECEIVING NEOADJUVANT CHEMORADIOTHERAPY.
Outcomes
Primary Outcomes
HEARING LOSS IN DECIBELS ACHIEVED BY PURE TONE AUDIOMETRY
Time Frame: PRE THERAPY, 3 WEEKS AFTER INITIATING THERAPY, AT THE COMPLETION OF THERAPY, 3 MONTHS FOLLOW UP
Secondary Outcomes
- DEGREE OF SEVERITY AND TYPE OF HEARING LOSS(PRE THERAPY, 3 WEEKS AFTER INITIATING THERAPY, AT THE COMPLETION OF THERAPY, 3 MONTHS FOLLOW UP)