Traditional Chinese Medicine Oral Liquids and Mouthwashes for Radiation-induced Oral Mucositis in Head and Neck Cancer Patients

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorWest China Hospital

About this trial

Evaluate the efficacy and safety of traditional Chinese medicine oral liquid and mouthwash in the treatment of radiotherapy induced oral mucositis in patients with head and neck malignancies

Eligibility criteria

Qualifiers

Patients pathologically diagnosed with non-metastatic head and neck malignant tumors;

Age range: 18 to 65 years old (including 18 and 65 years old);

Eastern Cooperative Oncology Group performance status of ≤2;

Radiotherapy or concurrent chemoradiotherapy is required;

Disqualifiers

Allergic constitution (such as those known to be allergic to two or more drugs);

Patients who plan to use drugs that can cause or worsen oral mucosal inflammation (such as anti EGFR monoclonal antibodies, immune checkpoint inhibitors, etc.) after the start of radiotherapy;

Use of antibiotics, antifungal drugs, or antimicrobial mouthwash within 1 month of the study;

Poor oral hygiene and/or severe periodontal diseases;

Trial design

Treatments tested in this trial

  • Qingying oral liquid and modified Da Huang-Huang Lian Xiexin mouthwash
  • Placebo oral solution and mouthwash
  • radiotherapy

Treatment groups

118 Participants
are divided into 2 treatment groups

Sponsors and collaborators