Nanfang hospital, Southern medical university
Guangzhou, Guangdong, 510515, China
Location status: Recruiting
NCT Number: NCT06968520
Radiotherapy is the main treatment method for head and neck tumors. However, almost all patients with head and neck tumors will develop acute inflammatory reactions such as Radiotherapy-Induced Oral Mucositis (RIOM) after receiving Radiotherapy, resulting in a decline in the quality of life of patients, hindering the smooth implementation of the treatment plan, reducing the therapeutic effect, and increasing the economic burden of patients. However, the current treatment strategies for RIOM focus on symptomatic treatment and have little impact on the course, severity and related complications of mucositis. Therefore, exploring effective strategies, predicting the incidence and severity of RIOM in patients, and providing prevention and treatment are the clinical bottlenecks and cutting-edge issues that urgently need to be solved in the current clinical practice of radiotherapy for head and neck tumors. Previous studies have shown that the steady-state of metallic elements may be closely related to the occurrence and development of RIOM. Therefore, we plan to conduct a prospective, single-center, observational study to further explore the correlation between metal elements and severe RIOM, analyze its predictive efficacy, and observe the dynamic changes of metal elements in radiotherapy.
Interested in participating?
Request Info18 year–75 year
All sexes
Observational
Guangzhou, Guangdong, 510515, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
1)Sign the informed consent form; 2) Confirmed by pathological biopsy as nasopharyngeal carcinoma or head and neck tumors; 3) Have indications for radiotherapy and voluntarily accept radiotherapy; 4) ECOG PS: 0/1; 5) Age: 18-75 years old; 6) Laboratory tests confirm good organ function.
Exclusion criteria
Time frame: Through study completion, up to 1 year
The incidence rates of sever radiation-induced oral mucositis across various severity grades will be determined.Grade>=3 is regarded as severe RTOM.
Time frame: Through study completion, up to 1 year
Recording the start time and duration of RTOM and SRTOM.
Time frame: Through study completion, up to 1 year
The quality of life including physical health, mental health, spiritual health and social and interpersonal relationships.
Time frame: Through study completion, up to 1 year
Other recent adverse radiation reactions caused by radiotherapy
Nanfang Hospital, Southern Medical University
Other
Correlation and Predictive Study of Metal Elements in Radiation-Induced Oral Mucositis: A Prospective, Longitudinal Cohort Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06767488
Breathomics, Head and Neck Neoplasms
Guangzhou, Guangdong, China
View Trial DetailsNCT06479811
Carcinoma, Cranial Nerve Diseases
Bethesda, Maryland, United States
View Trial DetailsNCT07552467
Astrocytoma, Breast Cancer
Wuhan, Hubei, China
View Trial DetailsNCT05671458
Head and Neck Neoplasms, Head and Neck Tumors
Heidelberg, Germany
View Trial Details