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Compares treatment options for Nasopharyngeal Carcinoma (NPC)
Official title Sapylin Versus Dexamethasone Inhalation for CCRT-Induced Oral Mucositis in Nasopharyngeal Carcinoma
ClinicalTrials.gov ID: NCT07327216
What this study is testing
What is Sapylin?
Sapylin is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for nasopharyngeal carcinoma (npc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Radiation therapy is the main treatment for nasopharyngeal carcinoma (NPC), and standard care for advanced NPC often includes combination chemotherapy and radiation (CCRT). However, many patients experience serious side effects, such as painful mouth sores (Radiation-Induced Oral Mucositis, RTOM).
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Stage III-IVa NPC (AJCC 8th edition) diagnosed via pathology in a tertiary hospital;
- No previous radiotherapy, chemotherapy, surgery, immunization, or targeted therapy;
- Karnofsky Performance Status score ≥80;
- Intact and normal oral mucosa before treatment;
- Age 18-75 years;
You likely can't join if
- With other malignant tumors in the past or present and/or distant metastasis during treatment;
- Who have undergone surgery, chemoradiotherapy, and targeted immunotherapy;
- With a history of asthma, rash, urticaria, and other allergic diseases;
- With a history of autoimmune diseases, connective tissue diseases, and diabetes mellitus that significantly affect the healing of the oral mucosa;
- With concomitant diseases, such as heart disease, kidney disease, and acute infectious diseases, which are judged by the investigator to seriously...
- Who are breastfeeding, pregnant, or planning to become pregnant during the study;
See the full eligibility criteria
- Stage III-IVa NPC (AJCC 8th edition) diagnosed via pathology in a tertiary hospital;
- No previous radiotherapy, chemotherapy, surgery, immunization, or targeted therapy;
- Karnofsky Performance Status score ≥80;
- Intact and normal oral mucosa before treatment;
- Age 18-75 years;
- Voluntary participation and provision of informed consent in person;
- Routine blood examination: white blood cell count ≥4.0×109/L, hemoglobin ≥100g/L, neutrophil count ≥1.5×10\^9/L, and platelet count ≥100×10\^9/L;
- Biochemical examination: total bilirubin ≤1.5×the upper limit of the normal range (ULN), alanine aminotransferase and aspartate aminotransferase ≤2×ULN, and estimated glomerular filtration rate ≥60 mL/min.
- With other malignant tumors in the past or present and/or distant metastasis during treatment;
- Who have undergone surgery, chemoradiotherapy, and targeted immunotherapy;
- With a history of asthma, rash, urticaria, and other allergic diseases;
- With a history of autoimmune diseases, connective tissue diseases, and diabetes mellitus that significantly affect the healing of the oral mucosa;
- With concomitant diseases, such as heart disease, kidney disease, and acute infectious diseases, which are judged by the investigator to seriously endanger the safety of patients or affect the completion of the study;
- Who are breastfeeding, pregnant, or planning to become pregnant during the study;
- With known allergies to the therapeutic agents and penicillin used in the trial;
- Mental or nervous system diseases or poor compliance.
The study team makes the final eligibility decision.
Where it's taking place
- Zhanjiang, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zhanjiang, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.