Traditional Chinese Medicine for the Prevention of Radiotherapy-Induced Oral Mucositis (RTOM)

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology

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

Treatment groups

156 Participants
are divided into 2 treatment groups

Locations

This trial has no locations