| CTRI Number |
CTRI/2010/091/000555 [Registered on: 09/08/2010] |
| Last Modified On: |
14/03/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
Type of Study
Modification(s)
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study prevalence of Disorders of Breathing during sleep, like Sleep Apnea, in patients who have completed their treatment for any Oral Cancer.
|
|
Scientific Title of Study
|
A Pilot Cross-sectional Study of the Prevalence of Sleep Disordered Breadthing and Sleep Apnnea in Treated Locoregionally Controlled Head and Neck Cancer. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sandeep Tandon |
| Designation |
|
| Affiliation |
|
| Address |
Tata Memorial Centre
Dr E Borges Road,Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
24177000 extn4637 |
| Fax |
022-24146937 |
| Email |
sptandon@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandeep Tandon |
| Designation |
|
| Affiliation |
|
| Address |
Tata Memorial Centre
Dr E Borges Road,Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
24177000 extn4637 |
| Fax |
022-24146937 |
| Email |
sptandon@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sandeep Tandon |
| Designation |
|
| Affiliation |
|
| Address |
Tata Memorial Centre
Dr E Borges Road,Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
24177000 extn4637 |
| Fax |
022-24146937 |
| Email |
sptandon@gmail.com |
|
|
Source of Monetary or Material Support
|
|
Primary Sponsor
Modification(s)
|
| Name |
Tata Memorial Centre Intramural Fund |
| Address |
Dr Ernest Borges Marg,Parel,Mumbai 400012 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Nil |
|
| No sponsor for the study |
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sandeep Tandon |
Tata memorial Centre |
Dr E Borges Road,Parel-400012
Mumbai
MAHARASHTRA |
24177000 extn:4637
022-24146937
sptandon@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Human ethics Committee, Tata Memorial Centre ,Parel ,Mumbai 400012 |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Sleep disordedred Breadthing and Obstructive Sleep Apnea Hypopnea Syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Locoregionally controlled oral and oropharyngeal tumours who have completed treatment atleast 6 months prior to study in the form of either surgery or radiotherapy or surgery and radiotherapyor chemoradiation with the following surgical types:
1.mandibular resection either middle third ,hemi or extended hemimandibulectomy
2.more than hemiglossectomy
3.total glossectomy
4.oropharyngeal resection not involving larynx
5.major resection causing significant alteration of upper airway anatomy with major reconstruction. |
|
| ExclusionCriteria |
| Details |
1.Laryngeal tumours or resections or patients who have a tracheostomy
2.Haemodynamically unstable patients
3.Patients already diagnosed pre-treatment as SDB/OSAHS. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To detect incidence of SBD(sleep disordered breathing)and OSAHS(obstructive sleep apnea hypopnea syndrome)in treated locoregionally controlled Head and Neck cancer patients.
|
NA |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study quality of life and mental health of these patients and ascertain any association with SDB and OSAHS.
|
NA |
|
Target Sample Size
Modification(s)
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
Date of First Enrollment (India)
Modification(s)
|
03/09/2010 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
03/09/2010 |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
In process of being analysed and written up |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This observational cross-sectional study explores the hypothesis that the upper airway in patients who have undergone therapy for head and neck cancer either in the form of major reconstructive surgery with/without radiotherapy alone or chemoradiation ,would have long tem upper airway distortion ,inflammation ,fibrosis and loss of tone and calibre.This could cause significant upper airway collapse during sleep causing Sleep disordered Breadthing (SDB) and Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS).SDB is widely prevalent and underdiagnosed and causes compromised quality of life with remarkable improvement with treatment.This problem has never been studied in the subset of Head and neck cancer patients in India .A significant association between the two could ,by early detection and treatment,significantly improve the Quality of Life and could provide a rationale for introduction of routine Polysomnography in follow up of all treated Head and Neck Cancer patients, considering that Oral Cancers constitute a large proportion of cancers treated at our institution. |