| CTRI Number |
CTRI/2014/08/004940 [Registered on: 28/08/2014] Trial Registered Retrospectively |
| Last Modified On: |
27/08/2014 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
STUDY TO ASSESS HEARING LOSS IN PATIENTS RECEIVING SIMULTANEOUS CHEMOTHERAPY AND RADIATION THERAPY FOR HEAD AND NECK CANCERS |
|
Scientific Title of Study
|
STUDY TO ASSESS HEARING LOSS IN PATIENTS RECEIVING CHEMORADIOTHERAPY IN ADJUVANT SETTING FOR HEAD AND NECK MALIGNANCY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR VANI KRISHANA GUPTA |
| Designation |
RESIDENT |
| Affiliation |
FATHER MULLER MEDICAL COLLEGE |
| Address |
DEPARTMENT OF ENT,
FATHER MULLER MEDICAL COLLEGE,
KANKANADY,
MANGALORE
Dakshina Kannada KARNATAKA 575002 India |
| Phone |
9900405811 |
| Fax |
|
| Email |
vanikrishanagupta@yahoo.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR MAHESH BHAT |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
FATHER MULLER MEDICAL COLLEGE |
| Address |
DEPARTMENT OF ENT,
FATHER MULLER MEDICAL COLLEGE,
KANKANADY,
MANGALORE
Dakshina Kannada KARNATAKA 575002 India |
| Phone |
9886734374 |
| Fax |
|
| Email |
mahesh.t.bhat@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DR VANI KRISHANA GUPTA |
| Designation |
RESIDENT |
| Affiliation |
FATHER MULLER MEDICAL COLLEGE |
| Address |
DEPARTMENT OF ENT,
FATHER MULLER MEDICAL COLLEGE,
KANKANADY,
MANGALORE
Dakshina Kannada KARNATAKA 575002 India |
| Phone |
9900405811 |
| Fax |
|
| Email |
vanikrishanagupta@yahoo.com |
|
|
Source of Monetary or Material Support
|
| FATHER MULLER MEDICAL COLLEGE |
|
|
Primary Sponsor
|
| Name |
FATHER MULLER MEDICAL COLLEGE |
| Address |
FATHER MULLER MEDICAL COLLEGE,
KANKANADY,
MANGALORE
575002 |
| Type of Sponsor |
Private 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 VANI KRISHANA GUPTA |
In patients of departments of ENT and radiation Oncology in Father Muller hospital |
FATHER MULLER MEDICAL COLLEGE,
KANKANADY,
MANGALORE Dakshina Kannada KARNATAKA |
9900405811
vanikrishanagupta@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| FATHER MULLER MEDICAL COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
SUFFERING FROM HEAD AND NECK MALIGNANCIES, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
INDIVIDUALS ALREADY SUFFERING FROM PROFOUND HEARING LOSS AND RECEIVING NEOADJUVANT CHEMORADIOTHERAPY |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| HEARING LOSS IN DECIBELS ACHIEVED BY PURE TONE AUDIOMETRY |
PRE THERAPY, 3 WEEKS AFTER INITIATING THERAPY, AT THE COMPLETION OF THERAPY, 3 MONTHS FOLLOW UP |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| DEGREE OF SEVERITY AND TYPE OF HEARING LOSS |
PRE THERAPY, 3 WEEKS AFTER INITIATING THERAPY, AT THE COMPLETION OF THERAPY, 3 MONTHS FOLLOW UP |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
17/09/2013 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="11" Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Head and
neck cancers in India account for 30% of all cancers. In India, 60 to 80 % of
patients present with advanced disease as compared to 40% in developed
countries. Chemoradiotherapy (CTRT) is the most common modality
of treatment for advanced head and neck cancers. Radiation induced sensorineural
hearing loss (SNHL) is an important side effect as the temporal bone is often
included in the field of radiation. It is usually high frequency
SNHL that occurs either during or 6-24 months after therapy and may progress to
complete deafness. The widely used chemotherapeutic drug, cisplatin, is also
known to cause ototoxicity, thus adding to the SNHL.
This hearing impairment can cause
significant disability in these patients especially in cases of binaural
hearing loss, hence this should be kept in mind during the pre- radiotherapy
counseling and post-radiotherapy follow-up of these patients. Many
of the previous reports were based on studies that were either retrospective or
involved a limited number of patients. The aim of this study is the qualitative
and quantitative assessment of hearing loss in patients receiving CTRT in
adjuvant settings for head and neck malignancy. |