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A randomized, open, multicenter clinical study of radiation-induced oral mucositis in head and neck cancer patients treated with medical radiation protectant spray

A randomized, open, multicenter clinical study of radiation-induced oral mucositis in head and neck cancer patients treated with medical radiation protectant spray

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500106150
Enrollment
Unknown
Registered
2025-07-18
Start date
2025-07-18
Completion date
Unknown
Last updated
2025-07-21

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

Experimental group:medical radiation protectant spray + gargle
Control group:placeb+ gargle

Sponsors

The First Hospital of Jilin University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged >= 18 years; 2. Diagnosed with head and neck tumors by histopathology; 3. Patients who are receiving radiation therapy for the first time and have irradiation to the oral mucosal area; 4. The patient's Eastern Cooperative Oncology Group (ECOG) score <=3; 5. Able to read, understand, follow study procedures and complete patient diaries independently.

Exclusion criteria

Exclusion criteria: 1. Currently using illegal drugs or currently experiencing alcoholism; 2. Patients with underlying diseases associated with oral infection; 3. The patient is using therapeutic drugs that may cause oral infection; 4. Combined with severe chronic diseases; 5. Patients with mental illness and severe cognitive impairment; 6. The investigator believes that the administration of the study treatment may confound the study results or cause a risk of uncertainty; 7. Patients with a history of head and neck radiotherapy; 8. Patients who refuse to be followed up.

Design outcomes

Primary

MeasureTime frame
oral mucositis;

Secondary

MeasureTime frame
nutritional status assessment;the immune function;

Countries

China

Contacts

Public ContactXin Jiang

The First Hospital of Jilin University

jiangx@jlu.edu.cn+86 158 0430 2750

Outcome results

None listed

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