Traditional Chinese Medicine Preparation Alleviates Radiotherapy-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 effectiveness and safety of traditional Chinese medicine compound in improving radiotherapy-induced oral mucositis in patients with head and neck malignant tumors.

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

  • Placebo oral liquid and mouthwash
  • Zishui Daohuo oral liquid combined with Kujiu mouthwash
  • Radiotherapy

Treatment groups

128 Participants
are divided into 2 treatment groups

Sponsors and collaborators