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A randomized, controlled, multicenter clinical trial on the effect of Ipsu oral gel on oral mucositis and basic status in patients with head and neck tumor radiotherapy

A randomized, controlled, multicenter clinical trial on the effect of Ipsu oral gel on oral mucositis and basic status in patients with head and neck tumor radiotherapy

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100055088
Enrollment
Unknown
Registered
2021-12-31
Start date
2022-01-10
Completion date
Unknown
Last updated
2023-01-09

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:Lpsu oral gel + gargle

Sponsors

The First Hospital of Jilin University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Diagnosed with head and neck tumors by histopathology; 2. Sign the written informed consent; 3. Aged >= 18 years, no gender limit; 4. The patient has no serious endocrine and metabolic diseases; 5. Patients with head and neck tumors who received radiation therapy for the first time; 6. The patient developed OM during radiotherapy; 7. The patient's Eastern Cooperative Oncology Group (ECOG) score <=3; 8. 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 who refuse to be followed up.

Design outcomes

Primary

MeasureTime frame
oral mucositis;pain;nutritional status assessment;the immune function;

Countries

China

Contacts

Public ContactJiang Xin

The First Hospital of Jilin University

jiangx@jlu.edu.cn+86 15804302750

Outcome results

None listed

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