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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.

Assessing topical methylene blue efficacy for radiation-induced oral mucositis pain: a single arm phase ii clinical trial. - NIL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/04/065944
Enrollment
35
Registered
2024-04-18
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx

Interventions

Intervention1: ASSESSING TOPICAL METHYLENE BLUE EFFICACY FOR RADIATION-INDUCED ORAL MUCOSITIS PAIN: A SINGLE ARM PHASE II CLINICAL TRIAL: In instances where patients report a pain score greater than 4

Sponsors

Navas Bright
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
1.Oral functioning of the patient with radiation induced OM on methylene blue rinse. 2.Dose of systemic analgesics and adjuvants in patients receiving methylene blue. 3. Side effects of methylene blue on topical use for oral mucositis. Timepoint: Four weeks of starting intervention.

Countries

India

Contacts

Public ContactNavas Bright

Cancer Institute (WIA)

meenaram99@yahoo.com9940370735

Outcome results

None listed

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