Nasopharyngeal Carcinoma, Radiation-induced Xerostomia
Conditions
Brief summary
This is a prospective phase II clinical randomized controlled study, the purpose of this study is to assess whether superficial parotid lobe-sparing intensity-modulated radiotherapy (SPLS-IMRT) can decrease the incidence of xerostomia versus conventional IMRT (C-IMRT) in NPC patients.
Interventions
RADIATIONsuperficial parotid lobe-sparing intensity-modulated radiotherapy
The superficial parotid lobe was contoured as an OAR, and V26 (the percentage volume receiving 26 Gy or more) in the superficial parotid lobe was constrained to be less than 30%.
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1) newly diagnosed, histologically confirmed World Health Organization (WHO) type II-III NPC; 2) stage I-IVa (T1-4 N0-3M0) according to the staging system of the 8th American Joint Committee on Cancer/Union for International Cancer Control (AJCC/UICC); 3) no prior antitumor therapy; 4) no tumor involvement in salivary gland; 5) no parotid glands disorder and no history of parotid glands surgery; 6) ages between 18 and 70 years; 7) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, and 8) adequate organ function
Exclusion criteria
1) used salivary stimulating or protecting agent; 2) metachronous or synchronous malignancy; 3) pregnancy or lactation; or 4) severe comorbidities. The pretreatment evaluation included a complete history and physical examination, nasopharyngoscopy, chest X-ray, complete blood count, liver and renal biochemistry, and magnetic resonance imaging (MRI) of the head and neck.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the incidence of xerostomia | 12 months | the incidence of xerostomia at 12m post-RT based on Radiation Therapy Oncology Group (RTOG) criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| xerostomia questionnaire score | 12 months | The XQ consisted of 8 specific questions which were listed as follows: difficulty in talking; difficulty in chewing; difficulty in swallowing solid food; frequency of sleeping problems; mouth and throat dryness when eating food; mouth and throat dryness while not eating; frequency of sipping liquids to aid swallowing food; frequency of sipping liquids for oral comfort when not eating. |
| Salivary flow rate | 12 months | unstimulated salivary flow rateand stimulated salivary flow rate |
| locoregional relapse-free survival | 36 months | — |
| distant metastasis-free survival | 36 months | — |
| overall survival | 36 months | — |
Countries
China
Outcome results
None listed