About this trial
This is a multicenter, randomized, controlled, prospective clinical trial designed to observe and evaluate the safety and efficacy of Modified Dahuang Huanglian Xiexin Mouthwash for the prevention of radiotherapy-induced oral mucositis (RTOM).
Participants will be randomly assigned to receive either the Modified Dahuang Huanglian Xiexin Mouthwash or Placebo Mouthwash. The study aims to assess the preventative effect on RTOM in patients undergoing radiotherapy.
Eligibility criteria
Qualifiers
Aged 18 to 70 years (inclusive) at the time of screening.
Histologically confirmed squamous cell carcinoma of the nasopharynx, oral cavity, or oropharynx.
Planned to receive radiotherapy.
No prior history of radiotherapy to the head and neck region.
Disqualifiers
Pre-existing oral mucositis prior to the start of radiotherapy.
Prior radiotherapy to the head and neck region.
Major surgery within 3 weeks prior to enrollment.
Use of topical (oral) or systemic corticosteroids within 1 week prior to enrollment.
Trial design
Treatments tested in this trial
- Modified Dahuang Huanglian Xiexin Mouthwash
- Placebo Mouthwash