Traditional Chinese Medicine for the Prevention of Radiotherapy-Induced Oral Mucositis (RTOM) (NCT07543978) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Traditional Chinese Medicine for the Prevention of Radiotherapy-Induced Oral Mucositis (RTOM)
156 participantsStarted 2026-04-30
Plain-language summary
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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
✓. Adequate major organ function as defined by the following criteria (within 14 days prior to enrollment, without transfusion support):
✓. Signed written informed consent prior to any study-related procedures.
✓. Judged by the investigator to be able to comply with the study protocol.
Exclusion criteria
✕. 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.
✕. Uncontrolled cardiac conditions or symptoms, including but not limited to:
✕. Use of topical (oral) or systemic corticosteroids within 1 week prior to enrollment.
What they're measuring
1
Incidence of Radiation-Induced Oral Mucositis Within 2 Weeks of Radiotherapy Initiation
Timeframe: From start of radiotherapy to the 2-week assessment point (day 14 ± 3 days)
Trial details
NCT IDNCT07543978
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology