| CTRI Number |
CTRI/2018/01/011408 [Registered on: 18/01/2018] Trial Registered Retrospectively |
| Last Modified On: |
27/01/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Preventive |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
A study on the protective effect of local application of butter in oral cavity problems caused by radiotherapy in Head and Neck cancer patients. |
|
Scientific Title of Study
|
A study on the protective effect of topical administration of butter on radiation induced oral mucositis in Head and Neck cancer patients. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Remya koikkara |
| Designation |
junior resident |
| Affiliation |
k s hegde hospital |
| Address |
k s hegde hospital
department of ENT
deralakatta
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9035922369 |
| Fax |
|
| Email |
rkoikkara@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajeshwary A |
| Designation |
HOD &professor |
| Affiliation |
k s hegde hospital |
| Address |
k s hegde hospital
department of ENT
deralakatta
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9448150448 |
| Fax |
|
| Email |
hod.ent.kshema@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Remya koikkara |
| Designation |
junior resident |
| Affiliation |
k s hegde hospital |
| Address |
k s hegde hospital
department of ENT
deralakatta
KARNATAKA
575018
India |
| Phone |
9035922369 |
| Fax |
|
| Email |
rkoikkara@gmail.com |
|
|
Source of Monetary or Material Support
|
| k s hegde hospital,deralkatte ,mangalore |
|
|
Primary Sponsor
|
| Name |
K S Hegde hospital |
| Address |
k s hegde charitable hospital,deralkatte
mangalore,karnataka
pin 575018 |
| 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 Remya koikkara |
K .S .Hegde |
room no 14
department of ent
Dakshina Kannada
KARNATAKA |
918242204476
rkoikkara@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C140||Malignant neoplasm of pharynx, unspecified, patients undergoing radiotherapy for head and neck malignancy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Amul butter |
Amul butter -manufactured by amulfed diary |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.patients undergoing radiotherapy for head and neck malignancy |
|
| ExclusionCriteria |
| Details |
1.Patients having food allergy.
2.Patients not willing for the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| degree of radiation induced mucositis in head and neck malignancy is less with topical application of cows butter |
every 7 th day of radiation therapy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
15/08/2017 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Radiation induced mucositis is a common complication of radiation in head and neck cancer therapy .They are painful and affectnurtion and quality of the life of the patient .No approach has been demonstrated to be effective in the prevention or treatment of oral mucositis.This study is undertaken with an objective of to assess the effect of application of cows butter in prevention of oral mucositis among subjects undergoing chemoradiotherapy for head and neck cancers . |