Clinical trial · Interventional
Interleukin-11 Can Prevent and Treat of Radioactive Oral Mucitis
The Open and Multi-center Phase III Clinical Study of Interleukin-11 in the Prevention and Treatment of Radioactive Oral Mucitis
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Radiation induced oral mucositis which may result in reduced quality of life is commonly seen during radiotherapy, especially combined with chemotherapy. This study is a prospective, multicenter, and exploratory study. The aim of this study is to explore predictive factors of acute radiotherapy induced oral mucositis in nasopharyngeal carcinoma patients treated with radio-chemotherapy and reduce incidence of oral mucositis by using recombinant human interleukin -11.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nasopharyngeal Carcinoma | Nasopharyngeal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Recombinant Human Interleukin-11 | Drug | — | UNRESOLVED |
| Saline | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Recombinant human interleukin-11
- description
- Mixture of 1.5 mg recombinant human interleukin -11(IL-11) and 10ml 0.9% normal saline(NS) was administered twicely to patients through respiratory tract.
- interventionNames
- Drug: Recombinant Human Interleukin-11
- Drug: Saline
- type
- PLACEBO_COMPARATOR
- label
- Saline
- description
- Only 10ml 0.9% NS was administered twicely to patients through respiratory tract.
- interventionNames
- Drug: Saline
Primary outcomes (1)
- measure
- Incidence of severe acute radioactive oral mucitis
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Clinical diagnosis of nasopharyngeal carcinoma. 2. 8th version American Joint Committee on Cancer (AJCC) stage I-IVB. 3. Age must beetween 18-75. 4. Performance status must be 0 or 1 according to Eastern Cooperative Oncology Group. 5. Adequate bone marrow, renal, and hepatic function. Exclusion Criteria: 1. chemotherapy with fluorouracil drugs; Allergies to recombinant human interleukin-11. 2. Treatment with palliative intent.;Previous malignancy. 3. Pregnancy or lactation. 4. A history of previous radiotherapy, chemotherapy, or surgery (except diagnostic) to the primary tumor or nodes. 5. Diabetes, oral mucositis and senile dry stomatitis. 6. Any severe coexisting disease.
References
Publications (0)
Data not yet available