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A multicenter, randomized, controlled trial: the effect of Kangfuxin Solution on the radiation induced oral and upper gastrointestinal mucositis in nasopharyngeal carcinoma patients

A multicenter, randomized, controlled trial: the effect of Kangfuxin Solution on the radiation induced oral and upper gastrointestinal mucositis in nasopharyngeal carcinoma patients

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-15006687
Enrollment
Unknown
Registered
2015-07-02
Start date
2012-07-24
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

nasopharyngeal carcinoma

Interventions

Control group:Compound Borax gargle

Sponsors

Sichuan Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. written informed consent; 2. male or female patient 18-70 years of age; 3. initial histologically or cytologically confirmed nasopharyngeal carcinoma with no metastasis; 4. patients with Stage I/II/III/IV were all included (AJCC 2010); 5. scheduled to receive radiotherapy and/or chemotherapy; 6. KPS>=70; 7. Lifetime at least >=6 months.

Exclusion criteria

Exclusion criteria: 1. patients with active oral infectious diseases, including oropharyngeal candidiasis,facialherpes or other oral diseases; 2. elderly patients with dry stomatitis; 3. patients with recurrent or residual nasopharyngeal carcinoma; 4. patients who are scheduled to receive 5-fluorouracil regimen in neoadjuvant chemotherapy or chemoradiotherapy; 5. patients with treatment of molecular targeted therapeutic drugs simultaneously; 6. patients with severe heart, liver, kidney, hematopoietic system and nervous system disease, psychotics, and patients with plasma glucose poorly controlled undertaking; 7. allergies, known or suspected anaphylaxis for drug; 8. pregnancy and/or nursing mothers,and/or female patients of childbearing potential who can not taking effective contraception in study; 9. used to participat in other clinical trials within three months; 10. alcohol and/or drug abusers; 11. patients who are considered that not suitable for study.

Design outcomes

Primary

MeasureTime frame
oral mucositis;

Secondary

MeasureTime frame
gastrointestinal mucositis;mouth pain;

Countries

China

Contacts

Public ContactJinyi Lang
langjy610@163.com+86 028 85420152

Outcome results

None listed

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