Nasopharyngeal carcinoma
Conditions
Interventions
Hyperbaric oxygen treatment group:Hyperbaric oxygen treatments after re-radiotherapy (First Affiliated Hospital of Sun Yat-sen University, 100% oxygen, 200-220 kPa, 60-90 minutes, once a day, 5 times
Control group:No additional treatments after re-radiotherapy
Sponsors
Sun Yat-Sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients who participate voluntarily and sign an informed consent form in writing; 2. Patients who were previously diagnosed with primary nasopharyngeal carcinoma and received definitive radiotherapy. When enrolled, patients are diagnosed with recurrent nasopharyngeal carcinoma with pathological confirmation, and the pathological diagnosis was non-keratosis carcinoma (differentiated or undifferentiated type, that is, WHO classification type II or type III); 3. Patients who are clinically staged with rT2-4N0-3M0 II-IVa (according to the 8h edition of AJCC/UICC staging), and not suitable for surgery, plan to receive the second course of radiotherapy, with or without chemotherapy, immunotherapy and targeted therapy; 4. Patients with neck lymph nodes involved or uninvolved; 5. The interval between the end of first course of radiotherapy and the diagnosis of recurrence is more than 12 months; 6. No secondary malignancy of the head, neck and other parts; 7. Ages with 18-70 years old, male or female; 8. Eastern Tumor Collaboration Group (ECOG) performance status score is 0 or 1; 9. Expected survival more than 3 months.
Exclusion criteria
Exclusion criteria: 1. Patients with simple cervical lymph node recurrence or with distant metastatic lesions; 2. Contraindications to hyperbaric oxygen therapy: lung diseases (severe chronic obstructive airway disease, bullous lung disease, acute or chronic lung infection, uncontrolled asthma, untreated pneumothorax), previous middle ear surgery history, middle ear disease (Eustachian tube dysfunction, purulent otitis media), eye diseases (non-congestive glaucoma, retinal detachment); 3. Have previously received hyperbaric oxygen therapy; 4. Nasopharyngeal necrosis has occurred before enrollment; 5. Pregnant or lactating women; 6. Mechanical ventilation support is required; 7. Inability to follow and understand simple commands; 8. Disorientation and mental abnormalities.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of nasopharyngeal necrosis within 1-year of re-radiotherapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidences of other radiation-related complications within 1-year of re-radiotherapy;Quality of life after re-radiotherapy;Overall survival;Progression-free survival;Adverse reactions associated with hyperbaric oxygen therapy; | — |
Countries
China
Contacts
Public ContactHaiqiang Mai
Sun Yat-Sen University Cancer Center
Outcome results
None listed