Head and neck cancer receiving concurrent chemoradiotherapy complicated by oral mucositis (inflammation and ulceration of the mouth lining). Head and Neck cancer Chemoradiotherapy Oral Mucositis Benzydamine Hydrochloride Sodium Bicarbonate Mouthwashes Randomized Controlled Trial Quality of Life
Conditions
Interventions
DuoGargle mouthwash consisting of benzydamine hydrochloride solution used together with sodium bicarbonate solution. Participants gargle with sodium bicarbonate then benzydamine according to study sch
Experimental Drug,Active Comparator Drug
DuoGargle,BenzydamineOnly
Sponsors
Faculty of Medicine, Chulalongkorn University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age equal or more than 18 years. 2. Diagnosed with head and neck cancer confirmed by pathology as squamous cell carcinoma, with the primary tumor site located in the oral cavity, oropharynx, nasopharynx, larynx (except T1-2N0M0), hypopharynx, paranasal sinus or nasal cavity 3. Planned treatment with chemoradiation (either adjuvant or definitive) with a curative intent 4. Adequate organ function: 5. ECOG performance status 0-2 6. No history of allergy to the study medications: Benzydamine hydrochloride (mouthwash) or sodium bicarbonate 7. Written informed consent to participate in the study
Exclusion criteria
Exclusion criteria: 1. Medical comorbidities: - severe cardiovascular disease; unstable angina, NYHA class III/IV, heart failure - Active infection requiring systemic therapy - Uncontrolled diabetes (HbA1C > 8%) - Autoimmune disorders requiring immune suppression 2. Other active malignancies, or prior cancer within 5 years 3. Pregnancy and breastfeeding condition 4. Allergies: hypersensitivity to study drugs (cisplatin or mouthwash components) 5. Prior chemotherapy/radiotherapy for head/neck cancer within 3 months 6. Using intraoral stent (IOS) during radiotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OMAS score week 7 Clinician-rated OMAS total score 0-5, highest weekly value recorded. | — |
Secondary
| Measure | Time frame |
|---|---|
| Grade of oral mucositis weekly Common Terminology Criteria for Adverse Events version 5.0, clinician-graded,Use of local anesthetic mouthwash Weekly Recorded as yes/no and number of days of use from medication record or patient diary,Use of opioid analgesic Weekly Recorded as yes or no,Morphine usage Weekly Recorded as yes or no,Use of feeding tube Weekly Insertion of nasogastric or gastrostomy feeding tube recorded as yes/no,Body weight change from baseline Weekly Difference in body weight in kilograms from baseline measurement,Quality of life by EORTC-QLQ35 score weekly Questionare | — |
Countries
Thailand
Contacts
Public ContactChanida Vinayanuwattikun
King Chulalongkorn Memorial Hospital
Outcome results
None listed