Skip to content

Efficacy and safety of Rabdosia rubescens dropping pills in the prevention and treatment of radioactive oral mucositis in nasopharyngeal carcinoma: a prospective single-arm clinical trial at stage II

Efficacy and safety of Rabdosia rubescens dropping pills in the prevention and treatment of radioactive oral mucositis in nasopharyngeal carcinoma: a prospective single-arm clinical trial at stage II

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800015210
Enrollment
Unknown
Registered
2018-03-14
Start date
2018-02-01
Completion date
Unknown
Last updated
2018-03-19

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

Conditions

nasopharyngeal darcinoma

Interventions

Case series:The first day of radiotherapy, oral Rabdosia Rubescens drop pills
Regular use of sodium bicarbonate gargle, but keep a detailed record
When pain level 2 is reached, Lidocaine is given for pain relief, but detailed records are required

Sponsors

Sichuan Provincial Tumor Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Willingness to participate in the trial and sign the informed consent file; (2) Aged 18 and 70 years male or female; (3) Nasopharyngeal carcinoma with no distant metastasis was confirmed by histopathology; (4) The patients with stage I, II, III, IVA, IVB in the clinical stage of nasopharyngeal carcinoma in the eighth edition of AJCC were diagnosed as stage I, II, III, IVA, IVB; (5) Radical radiotherapy and chemotherapy were scheduled (IMRT technique was used for radiotherapy and cisplatin regimen was used for chemotherapy; (6) KPS = 70 (see Annex I); (7) The life expectancy is at least 6 months.

Exclusion criteria

Exclusion criteria: (1) There are active oral infections, including candida oropharyngii and facial herpes, or other oral diseases; (2) Elderly patients with dry stomatitis; (3) Recurrent or residual nasopharyngeal carcinoma; (4) Patients undergoing chemotherapy with 5-fluorouracil regimen; (5) Patients receiving simultaneous molecular targeting therapy; (6) Patients with severe heart, liver, kidney, hematopoietic and nervous system diseases, psychosis, diabetic patients with unsatisfactory blood glucose control; (7) Allergic physique, known or suspected to be allergic to this test drug; (8) Pregnant, lactating women, and women of childbearing age that can not effectively contraception during the trial period; (9) Those who have participated in clinical trials of other drugs within 3 months; (10) Alcohol and/or drug abusers; (11) There are other researchers who do not consider it appropriate to take part in this trial.

Design outcomes

Primary

MeasureTime frame
Evaluation of the onset time of grade I, II, III oral mucositis by CTCAE3.0;

Secondary

MeasureTime frame
Incidence and degree of oral pain;CRP;T-cell subsets and NK cells;Nutrition risk screening 2002;

Countries

China

Contacts

Public ContactJinyi Lang

Sichuan Provincial Tumor Hospital

freda_fm@126.com+86 13908054564

Outcome results

None listed

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