| CTRI Number |
CTRI/2024/11/076607 [Registered on: 11/11/2024] Trial Registered Prospectively |
| Last Modified On: |
10/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
The assessment of study is by comparing vitamin b12 and benzydamine hydrochloride spray in radiation mucositis patients |
|
Scientific Title of Study
|
Comparative Assessment of Efficacy of Vitamin B12 spray versus Benzydamine Hydrochloride spray in Prevention and Management of Radiation Mucositis-A Randomized Clinical Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mandapati Harshitha |
| Designation |
Post graduate |
| Affiliation |
Narayana Dental College and Hospital |
| Address |
Oral Medicine Diagnosis and Radiology Room No 1 Narayana Dental College and Hospital Chintareddy palem Nellore
Nellore
ANDHRA PRADESH
524002
India |
| Phone |
8074716814 |
| Fax |
|
| Email |
mandapati.harshitha97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rakesh Kumar Manne |
| Designation |
Professor |
| Affiliation |
Narayana Dental College and Hospital |
| Address |
Oral Medicine Diagnosis and Radiology Room No 1 Narayana Dental College and Hospital Chintareddy Palem Nellore
Nellore
ANDHRA PRADESH
524002
India |
| Phone |
9704014747 |
| Fax |
|
| Email |
rmannae@reddiffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rakesh Kumar Manne |
| Designation |
Professor |
| Affiliation |
Narayana Dental College and Hospital |
| Address |
Oral Medicine Diagnosis and Radiology Room No 1 Narayana Dental College and Hospital Chinthareddy Palem Nellore
Nellore
ANDHRA PRADESH
524002
India |
| Phone |
9704014747 |
| Fax |
|
| Email |
rmannae@reddiffmail.com |
|
|
Source of Monetary or Material Support
|
| Narayana Dental College and Hospital, Chinthareddy palem ,Nellore-524003 |
|
|
Primary Sponsor
|
| Name |
Mandapati Harshitha |
| Address |
Oral medicine Diagnosis and Radiology Room No 1 Narayana Dental College and Hospital Chinthareddy Palem Nellore 524003 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Harshitha |
Indian Red Cross Society Cancer Society |
Sarai Angadi Centre Podalakur Road ZP Colony Nellore
Nellore
ANDHRA PRADESH |
8074716814
mandapati.harshitha97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee NDCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx, (2) ICD-10 Condition: C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Benzydamine Hydrochloride |
will be given orally which needs to be sprayed on mucosal surfaces for 8 weeks |
| Intervention |
Vitamin B12 Spray |
will be given orally which needs to be sprayed on the mucosal surfaces for 8 weeks |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
PATIENTS WILLING TO PARTICIPATE IN THE STUDY
PATIENTS WITH HEAD AND NECK CANCER WHO ARE PLANNED FOR RADIOTHERAPY |
|
| ExclusionCriteria |
| Details |
Patients who are not willing for the study
Patients who are on ryles tube
Patients who are on respiratory support |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain score using visual analog scale every week for 8 weeks
Erythema using WHO assessment scale every week for 8 weeks |
Pain score using visual analog scale every week for 8 weeks
Erythema using WHO assessment scale every week for 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TO KNOW THE EFFICACY OF VITAMIN B12 SPRAY |
GIVEN FOR 8 WEEKS |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
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 3 |
|
Date of First Enrollment (India)
|
28/11/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
MY AIM OF THE STUDY IS TO EVALUATE THE EFFICACY OF VITAMIN B12 ORAL SPRAY COMPARED TO BENZYDAMINE HYDROCHLORIDE SPRAYØ
Sample size was estimated using g power
analysis with effect size of 1.1, alpha error of 0.05 and 80 power total sample
size achieved was 28 i.e. 14 patients per each group.
Ø
A total number of 28 patients who will be
undergoing radiotherapy will be randomly assigned into 2 groups i.e. GROUP A
and GROUP B by simple random sampling using lottery method.
Ø
Group A (STUDY GROUP) will be given vitamin B12
oral spray four times a day before the start of radiation therapy till 2 weeks
after the radiation therapy.
Ø
Group B (CONTROL GROUP) will be given
benzydamine hydrochloride spray four times a day before the start of radiation
therapy till 2 weeks after the radiation therapy.
Ø
Patients in both the groups will be instructed
to use the spray as advised to them i.e. four times a day for eight weeks after
taking food.
Ø
Follow up will be done every week to check for
occurrence, progression and regression of oral mucositis symptoms are analysed
and recorded using WHO oral mucositis assessment scale and visual analogue scale.
Ø
The follow up assessment includes observation
of mucosal changes and changes in pain sensations before and after the start of
treatment and the time taken for remission of inflammation in oral mucosa |