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 range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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