| CTRI Number |
CTRI/2018/04/013362 [Registered on: 19/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
13/04/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Radiation Therapy
Preventive
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of the effect of Two Mouthwashes on Radiation induced Mouth Ulcers |
|
Scientific Title of Study
|
Comparison of the effectiveness of Curcumin and Benzydamine mouthwash on oral mucositis in head and neck cancer patients scheduled for radiotherapy – A Double Blinded Randomised Controlled Clinical Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Swikant Shah |
| Designation |
Post Graduate |
| Affiliation |
S.C.B dental college and hospital |
| Address |
Department Of Public Health Dentistry, 2nd Floor,
S.C.B Dental College And Hospital, Near P.G. Boys Hostel, S.C.B. Medical College Campus
Cuttack
ORISSA
753007
India |
| Phone |
9002579500 |
| Fax |
|
| Email |
swikantshah@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR HEMAMALINI RATH |
| Designation |
ASSOCIATE PROFESSOR & HOD |
| Affiliation |
S.C.B DENTAL COLLEGE & HOSPITAL |
| Address |
DEPARTMENT OF PUBLIC HEALTH DENTISTRY, 2ND FLOOR, S.C.B DENTAL COLLEGE AND HOSPITAL, NEAR P.G. BOYS HOSTEL, S.C.B. MEDICAL COLLEGE CAMPUS , CUTTACK.
Cuttack
ORISSA
753007
India |
| Phone |
9437225245 |
| Fax |
|
| Email |
hema_hr@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR HEMAMALINI RATH |
| Designation |
ASSOCIATE PROFESSOR & HOD |
| Affiliation |
S.C.B DENTAL COLLEGE & HOSPITAL |
| Address |
DEPARTMENT OF PUBLIC HEALTH DENTISTRY, 2ND FLOOR, S.C.B DENTAL COLLEGE AND HOSPITAL, NEAR P.G. BOYS HOSTEL, S.C.B. MEDICAL COLLEGE CAMPUS , CUTTACK.
Cuttack
ORISSA
753007
India |
| Phone |
9002579500 |
| Fax |
|
| Email |
SWIKANTSHAH@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
| ACHARYA HARIHAR REGIONAL CANCER INSTITUTE, S.C.B.MEDICAL COLLEGE AND HOSPITAL, MANGALABAG, CUTTACK, ODISHA - 753007 |
|
|
Primary Sponsor
|
| Name |
DR SWIKANT SHAH |
| Address |
DEPARTMENT OF PUBLIC HEALTH DENTISTRY, 2ND FLOOR, S.C.B DENTAL HOSPITAL, NEAR P.G. BOYS HOSTEL, S.C.B. MEDICAL COLLEGE CAMPUS, CUTTACK- 753007 |
| 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 |
| DR SWIKANT SHAH |
Acharya Harihar Regional Cancer Institute |
Department of radio-oncology, Planning room and Simulation room
Cuttack
ORISSA |
9002579500
swikantshah@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE S.C.B. MEDICAL COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Head and neck cancer patients scheduled to receive radiation therapy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Benzydamine |
It is an anti-inflammatory agent in the form of mouthwash used at 0.15% concentration undiluted. It was administered orally for a period of six weeks (10ml-thrice daily) |
| Intervention |
Curcumin |
It is an extract of turmeric of which a mouth wash is made. In the mouthwash sodium benzoate (preservative) and clove oil is added.
0.1% curcumin mouthwash was administered orally for 6 weeks (10ml - thrice daily).
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient histo-pathologically confirmed to have head and neck cancer scheduled for Radio therapy.
2.Minimum period of radiotherapy - 4-6 weeks with radiation dose 0f ≥50Gy
3.Patients who are able to use mouthwash.
4.Patient with KARNOFSKY PERFORMANCE STATUS SCALE more than 60%
|
|
| ExclusionCriteria |
| Details |
1.Any physically handicapped condition which can affect the use of mouthwash
2.Patients who are on any other oral related medicine/mouthwash
3.Pregnant patients
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To assess the oral mucosal status prior to the onset of Radiotherapy using various scales for assessing Oral Mucositis.
2.To assess the change in Oral Mucositis in both study groups at 1st week, 2nd week, 3rd week,4th week, 5th week and 6th week of radiotherapy after using the mouthwash.
|
baseline, 1st week, 2nd week, 3rd week, 4th week, 5th week, 6th week
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To check patient compliance with the mouthwashes for both the study groups at 1st week, 2nd week, 3rd week,4th week,5th week and 6th week. |
1st week, 2nd week, 3rd week, 4th week, 5th week, 6th week |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "74"
Final Enrollment numbers achieved (India)="74" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
26/05/2016 |
| Date of Study Completion (India) |
15/09/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
A part of the study which was running parallel to the present study is published in Cancer Epidemiology.
Exploring determinants of care-seeking behaviour of oral cancer patients in
India: A qualitative content analysis.
Cancer Epidemiology 53 (2018) 141–148 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study is being conducted to
assess the effectiveness of a conventionally used mouthwash over a new
mouthwash in prevention as well as treatment of radiation induced oral
mucositis considering that both the mouthwashes have same effect on the oral
mucositis induced by radiotherapy. Currently oral mucositis is considered
to be most severe non-haematological complication affecting
40% - 80% of oral cancer patients on
chemotherapy and every head and neck cancer patients during the course of radiotherapy. It is observed scientifically that curcumin has anti-inflammatory, chemotherapeutic,
antiangiogenic, antioxidant, chemo preventive,
immunomodulation and wound healing Properties. Various
laboratory and clinical trials has been conducted to test the effect of curcumin in reducing incidence and severity of
radiation induced oral mucositis (RIOM). The results from these studies have provided encouraging
evidence regarding beneficial effect of
curcumin in reducing RIOM. But a strong data in support of this novel substance is still lacking. In the present
study, we found that the use of 0.1%
Curcumin not only reduced instantaneous risk of onset of RIOM by 50%, but also
delayed the onset by 14 days at least for 50% of patients as compared to use of
0.15% benzydamine mouthwash. |