| CTRI Number |
CTRI/2025/10/095573 [Registered on: 03/10/2025] Trial Registered Prospectively |
| Last Modified On: |
01/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Radiation Therapy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing effectiveness of mouth wash in prevention of mouth sore in oral cavity cancer undergoing Radiotherapy in post-opertative cases. |
|
Scientific Title of Study
|
Randomized Control Trial Comparing Efficacy of Benzydamine Mouth wash Vs Oral Honey Gargle in Prevention & Control of Oral Mucositis in Post- Operative Cases of Head & Neck Cancer receiving Adjuvant Radiotherapy. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 11000921 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashutosh Mukherji |
| Designation |
Professor and Head of Department |
| Affiliation |
Mahamana Pandit Madanmohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital, Varanasi |
| Address |
Office of Head of Department, Department of Radiation Oncology, MPMMCC, Varanasi, Uttar Pradesh 221005 India
Varanasi UTTAR PRADESH 221005 India |
| Phone |
9489146747 |
| Fax |
|
| Email |
drashutoshm@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sakshi Drad |
| Designation |
Junior Resident |
| Affiliation |
Mahamana Pandit Madanmohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital, Varanasi |
| Address |
Department of Radiation Oncology, MPMMCC and HBCH, Varanasi, Uttar Pradesh 221005 India
614,Bhagirathi Girls Hostel.
MPMMCC and HBCH, Varanasi, Uttar Pradesh 221005 India
Varanasi UTTAR PRADESH 221005 India |
| Phone |
9370959600 |
| Fax |
|
| Email |
dard.sakshi@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Gaurav Arya |
| Designation |
Research Fellow |
| Affiliation |
Mahamana Pandit Madanmohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital, Varanasi |
| Address |
Department of Radiation Oncology, MPMMCC and HBCH, Varanasi, Uttar Pradesh 221005 India
Varanasi UTTAR PRADESH 221005 India |
| Phone |
09031340291 |
| Fax |
|
| Email |
aryagaurav204@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Mahamana Pandit Madan Mohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital |
| Address |
Sundar Bagiya, Near Naria Gate, BHU Campus, Varanasi, Uttar Pradesh India 221005. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Sakshi |
Mahamana Pandit Madan Mohan Malviya Cancer Centre (MPMMCC) |
Office of Head of Department, Department of Radiation Oncology, MPMMCC, Varanasi, Uttar Pradesh 221005 India
Varanasi
UTTAR PRADESH
221005
India Varanasi UTTAR PRADESH |
9370959600
dard.sakshi@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
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C14||Malignant neoplasm of other and ill-defined sites in the lip, oral cavity and pharynx, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Benzydamine mouth wash (Control arm) |
Patients will be asked to rinse mouth and slowly gargle with Benzydamine mouth wash thrice daily i.e., 15 minutes before receiving radiation, 15 minutes after receiving radiation and 6 hours after the radiation therapy. |
| Intervention |
Honey (Experimental) Arm
|
Honey solution will be prepared as a 2:1 solution with 50ml honey in 25ml water. The solution
will be then distributed in 3 bottles of 15 ml each of honey solution per patient per day. All subjects
will be asked to rinse and slowly gargle the given solution in the mouth thrice daily i.e., 15 minutes
before receiving radiation, 15 minutes after receiving radiation and 6 hours after the radiation
therapy. Honey application will be done in vicinity. |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Histologically proven squamous cell carcinoma of oral cavity.
2.Age - 18 to 70 years
3.Both sexes
4.ECOG (Eastern Cooperative Oncology Group) 0-2
5.Adequate surgical resection of primary and nodal disease
6.Non-metastatic disease (T1-T4a, N0-3b).
7.Patients planned for adjuvant RT only with RT dose ranging from 60-64Gy in conventional fractions.
8.Patient able to read and write in their vernacular language.
|
|
| ExclusionCriteria |
| Details |
1.Patients with more than or equal to grade 2 trismus.
2.Pregnant or lactating women
3.Any histopathology other than Squamous cell carcinoma
4.Patient requiring concurrent chemotherapy.
5.Synchronous or Metachronous malignancy.
6.Metastatic disease (any T, any N, M1).
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the efficacy [percentage of cases developing higher grade (3 and 4) of oral mucositis] of oral honey wash and gargle versus Benzydamine mouth wash in prevention and control of acute oral mucositis evaluated using radiation therapy oncology group (RTOG grading system).
Secondary objective-
1. Duration of relief of oral mucositis.
2. Frequency of high-grade (Grade 3 and 4) oral mucositis during treatment.
3. Assessment of quality of life, local pain palliation via [Wong Baker Faces Pain Scale] in patients at start of RT, 6 weeks and 12 weeks post-RT.
|
To assess the efficacy [percentage of cases developing higher grade (3 and 4) of oral mucositis] of oral honey wash and gargle versus Benzydamine mouth wash in prevention and control of acute oral mucositis evaluated using radiation therapy oncology group (RTOG grading system).
Secondary objective-
1. Duration of relief of oral mucositis.
2. Frequency of high-grade (Grade 3 and 4) oral mucositis during treatment.
3. Assessment of quality of life, local pain palliation via [Wong Baker Faces Pain Scale] in patients at start of RT, 6 weeks and 12 weeks post-RT.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary objective-
1. Duration of relief of oral mucositis.
2. Frequency of high-grade (Grade 3 and 4) oral mucositis during treatment.
3. Assessment of quality of life, local pain palliation via [Wong Baker Faces Pain Scale] in patients at start of RT, 6 weeks and 12 weeks post-RT.
|
Secondary objective-
1. Duration of relief of oral mucositis.
2. Frequency of high-grade (Grade 3 and 4) oral mucositis during treatment.
3. Assessment of quality of life, local pain palliation via [Wong Baker Faces Pain Scale] in patients at start of RT, 6 weeks and 12 weeks post-RT.
|
|
|
Target Sample Size
|
Total Sample Size="212" Sample Size from India="212"
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)
|
31/10/2025 |
| 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="8" 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
|
Head and neck carcinomas are the most common cancer in India with oral cavity being the most common subsite and squamous cell carcinoma being the most common histology. Carcinoma of oral cavity is mostly confined to the primary site, with locoregional spread. Distant metastases are seen infrequently. Management of choice is usually definitive surgery, followed by adjuvant Radiotherapy with or without concurrent chemotherapy. Radiotherapy is delivered by using varying techniques. IMRT plays a critical role in the management of patients with head and neck (H&N) cancer. The advantage of IMRT over older/conventional techniques is that it can conform the dose to any complex target volume and avoid critical Organs at Risk (OARs). Oral mucositis is a frequent and distressing complication of adjuvant RT in patients treated for head and neck cancers. It significantly impairs oral intake, quality of life, and may necessitate treatment breaks, thereby compromising oncologic outcomes. Benzydamine mouthwash is currently recommended for mucositis prevention but may be associated with limitations such as availability, cost, and poor patient acceptability. Honey, a natural substance with proven anti-inflammatory and wound-healing properties, has shown potential in reducing mucositis severity in preliminary studies. However, there is a lack of robust, randomized controlled trials comparing honey gargle directly with Benzydamine mouthwash in this clinical setting. This study seeks to address this gap by evaluating whether honey gargle is non-inferior to Benzydamine mouthwash in preventing and controlling oral mucositis among post-operative head and neck cancer patients receiving adjuvant RT. |