Efficacy of pirfenidone in the prevention and management of oral mucositis in nasopharyngeal carcinoma patients: a phase 2 multi-institutional trial

A multicenter phase 2 clinical trial of pirfenidone in the prevention and treatment of oral mucosal inflammation caused by radiotherapy and chemotherapy in nasopharyngeal carcinoma patients

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400081900

Enrollment

Unknown

Registered

2024-03-14

Start date

2023-07-25

Completion date

Unknown

Last updated

2024-03-18

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

Conditions

nasopharyngeal carcinoma

Interventions

experimental group:Pirfenidone + basic treatment plan

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: a. The pathological type is non keratinizing carcinoma. b. The staging is T3-4N1/N2-3. c. There is no evidence of distant metastasis (M0). d. Functional status: KPS>70. e. Normal bone marrow function: white blood cell count>4 × 109/L, hemoglobin>90g/L, and platelet count>100 × 109/L. f. Normal liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST)60 ml/min h. The patient must be informed of the basic content of this study and sign an informed consent form. I. Accept neoadjuvant chemotherapy+synchronous radiotherapy and chemotherapy.

Exclusion criteria

Exclusion criteria: a. The pathological type is keratinizing squamous cell carcinoma or basal squamous cell carcinoma of WHO. b. Age>65 years old or<18 years old. c. The treatment is palliative. d. Has a history of malignant tumors in the past. Excluding fully treated basal cell carcinoma, squamous cell carcinoma, and cervical carcinoma in situ. e. Pregnant or lactating women (consider pregnancy testing for women of reproductive age; emphasize effective contraception during treatment). f. Previously received radiation therapy (excluding skin cancer that is not melanoma and the previous lesion is located outside the target area of radiation therapy). g. The primary lesion and cervical metastatic lesion have received chemotherapy or surgical treatment (excluding diagnostic treatment). h. Accompanied by other serious illnesses, it may bring significant risks or affect the compliance of the trial.

Design outcomes

Primary

Measure	Time frame
The incidence of severe oral mucositis;	—

Secondary

Measure	Time frame
The duration period of severe oral mucositis;Nutritional status;Quality of life;Fibrosis of the neck;Overall Survival(OS);Progress-free survival(PFS);acute and late adverse events (AEs);	—

Countries

China

Contacts

Public ContactJin Ting

Zhejiang Cancer Hospital

jinting@zjcc.org.cn+86 571 8812 8202

Outcome results

None listed

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