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Exploratory clinical Trial of Diammonium Glycyrrhizinate to Reduce Radiotherapy Induced Oral Mucositis in Patients with Nasopharyngeal Carcinoma

Exploratory clinical Trial of Diammonium Glycyrrhizinate to Reduce Radiotherapy Induced Oral Mucositis in Patients with Nasopharyngeal Carcinoma

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078519
Enrollment
Unknown
Registered
2023-12-11
Start date
2024-01-01
Completion date
Unknown
Last updated
2023-12-19

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:diammonium glycyrrhizinate
Control Group:Oral Care Education

Sponsors

Jiangxi Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1) Initial diagnosis of NPC patients 2) clinical stage I-IVa stage (UICC AJCC 8th edition) 3) receiving radical IMRT with or without chemotherapy 4) ECOG PS 0-2 5) Age 18-70 years 6) male or non-pregnant, lactating female 7) without hypernatremia and hypokalemia 8) hematologic examination: WBC > 4 × 109 L, neutrophil > 2 × 109 L, hemoglobin > 90 g/L, platelets >100 × 109 L 9) liver and kidney function: Alt, Ast GT; 60 ml/min) 10) signs an informed consent form

Exclusion criteria

Exclusion criteria: 1) allergic to diammonium glycyrrhizinate or soybean phospholipids 2) history of other malignancies (except basal-cell carcinoma squamous cell carcinoma of the skin and carcinoma in situ of the cervix) 3) history of radiotherapy (non-melanoma of the skin outside the target area of planned irradiation 4) serious concomitant disease that may pose a risk to the trial or affect compliance, such as unstable heart disease requiring treatment, kidney disease, chronic hepatitis, poorly controlled diabetes mellitus and psychosis 5)patients refused to be enrolled

Design outcomes

Primary

MeasureTime frame
Weight loss;

Secondary

MeasureTime frame
radiotherapy induced oral mucositis ;Days of use of hormones, antibiotics, and antifungal agents;Extension of radiation therapy days;Anemia after radiotherapy;The incidence of hypoalbuminemia;3-year progression free survival rate (PFS);3-year overall survival rate (OS);

Countries

China

Contacts

Public ContactTang Yiqiang

Jiangxi Cancer Hospital

johnytangyq@163.com+86 136 0791 6372

Outcome results

None listed

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