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Prophylaxis of oral mucositis with iodine solution in head & neck cancer patients during chemoradiation, a randomized controlled trial.

Prophylaxis of oral mucositis with iodine solution in head & neck cancer patients during chemoradiation, a randomized controlled trial. - Prophylaxis of oral mucositis with iodine solution in head & neck cancer patients during chemoradiation, a randomized controlled trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000042920
Enrollment
50
Registered
2021-01-06
Start date
2019-03-20
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Head and neck cancer

Interventions

- Iodine solution (Intervention) - Gargle 30 ml for 30 seconds - 3 times a day after meal - From the first day of concurrent chemoradiation to the day of completion - Normal saline solution (Contro

Sponsors

Faculty of Medicine, Khon Kaen University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients should be diagnosed with head and neck cancer without distant metastasis. 2) Patients should be between 18 -70 years old of age. 3) Patient should be receiving concurrent chemotherapy with a platinum-based agent. 4) Oral mucosa should be included in the radiation field. 5) The planned radiation dose to the primary tumor should exceed 50 Gy.

Exclusion criteria

Exclusion criteria: 1) Patients with an Eastern Cooperative Oncology Group Performance Score more than 2. 2) Patients with an allergy to iodine and/or seafood. 3) Patients who were unable to take part in the follow up schedule. 4) Patients who were pregnant or lactating. 5) Patients who had undergone prior radiation therapy. 6) Patients who were diagnosed with more than one primary cancer. 7) Patients who were diagnosed with hematologic malignancies. 8) Patients who were to undergo radiation therapy with altered fractionation. 9) Patients who were previously treated with hyperbaric oxygen therapy.

Design outcomes

Primary

MeasureTime frame
Oral Mucositis Assessment Scale

Secondary

MeasureTime frame
- Pain score - Impact on swallowing score - Incidence, severity, onset, & duration of oral mucositis - Analgesic drug use - Total treatment break - Secondary infection of oral mucosa.

Countries

Asia(except Japan)

Contacts

Public ContactYOTDANAI NAMUANGCHAN

Khon Kaen University Division of Radiation Oncology, Department of Radiology, Faculty of Medicine

yotdna@kku.ac.th+66-83-673-6731

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026