Comparing effectiveness of mouth wash in prevention of mouth sore in oral cavity cancer undergoing Radiotherapy in post-opertative cases.

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. - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/10/095573

Enrollment

212

Registered

2025-10-03

Start date

Unknown

Completion date

Unknown

Last updated

2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C14- Malignant neoplasm of other and ill-defined sites in the lip, oral cavity and pharynx

Interventions

Intervention1: 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 sol

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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).

Design outcomes

Primary

Measure	Time frame
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. Timepoint: 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.	—

Measure

Time frame

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. Timepoint: 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

Measure	Time frame
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. Timepoint: 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.	—

Measure

Time frame

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. Timepoint: 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.

—

Countries

India

Contacts

Public ContactGaurav Arya

Mahamana Pandit Madanmohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital, Varanasi

dard.sakshi@gmail.com9370959600

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026