This study is checking if putting methylene blue directly on the mouth sores caused by radiation can make the pain feel better, but its not comparing it to anything else.
Phase 2
- Conditions
- Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx
- Registration Number
- CTRI/2024/04/065944
- Lead Sponsor
- avas Bright
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Age more than 18 years
2. Oral cavity and oropharynx cancer patients
receiving radiation or chemoradiation
3. Oral cavity pain with NRS =4 and not on
analgesic for oral pain.
4. Pain score more =7, with or without
analgesia for oral pain
5. Any grade of oral mucositis
6. All stages of cancer with cancer-related
pain adequately controlled before radiation
7. Voluntary written consent.
Exclusion Criteria
1.Oro-cutaneous fistula
2.Inability to rinse/gargle/no mouth opening
3Known allergy to methylene blue
4.Cognitive impairment and inability to
consent
5.Confused/ agitated patient
6.Patient with cognitive impairment
7.Patients undergoing re-radiation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluate pain relief with topical methylene blue 0.025% in patients with radiation-induced oral mucositis.Timepoint: baseline, 1st hour, every day once for 2 weeks,then alternate day for 2 weeks.
- Secondary Outcome Measures
Name Time Method 1.Oral functioning of the patient with radiation induced OM on methylene blue rinse. <br/ ><br>2.Dose of systemic analgesics and adjuvants in patients receiving methylene blue. <br/ ><br>3. Side effects of methylene blue on topical use for oral mucositis. <br/ ><br>Timepoint: Four weeks of starting intervention.