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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  
NIL 
 
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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