Breathomics in the Diagnosis and Prediction of Radiotherapy-Induced Oropharyngeal Mucositis in He… (NCT06767488) | Clinical Trial Compass
RecruitingNot Applicable
Breathomics in the Diagnosis and Prediction of Radiotherapy-Induced Oropharyngeal Mucositis in Head and Neck Tumors
China375 participantsStarted 2024-12-06
Plain-language summary
Radiotherapy-Induced Oropharyngeal Mucositis (RIOM) is one of the most distressing side effects for patients with head and neck tumors during radiotherapy, requiring clinical physicians to manage it according to the severity of mucositis to alleviate symptoms and improve quality of life. However, traditional diagnosis of RIOM overly relies on subjective evaluation, lacks early sensitivity, and existing biomarker diagnostic methods suffer from insufficient efficacy, invasiveness, and inconsistent results. This study aims to explore the diagnostic and predictive value of exhaled breathomics in RIOM of head and neck tumors. By collecting exhaled breath samples from head and neck tumor patients undergoing radiotherapy and analyzing volatile organic compounds (VOCs) using breath detection technology, we aim to develop and validate a non-invasive diagnostic and predictive model based on exhaled breathomics. The study will identify specific VOCs as potential biomarkers, providing new tools for early diagnosis, timely prediction, and personalized treatment of RIOM.
Who can participate
Age range
18 Years – 75 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:
* Voluntarily sign informed consent. Over 18 years of age. Histologically confirmed head and neck tumors, treated with radiotherapy or chemoradiotherapy.
ECOG PS Score: 0/1/2.
Exclusion Criteria:
* Lung disease such as lung cancer, tuberculosis, and lung infections. Inhalation anesthesia within 3 months. Inhalation medication within 3 months. Postoperative laryngeal cancer. Concurrent serious uncontrolled medical conditions such as unstable heart disease requiring treatment, poorly controlled diabetes mellitus (fasting blood glucose \> 1.5 x upper limit of normal).
Participation deemed inappropriate in the judgment of the investigator.
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
Different grades radiotherapy-induced oral mucositis
Timeframe: Through study completion, up to 1 year
Trial details
NCT IDNCT06767488
SponsorNanfang Hospital, Southern Medical University