Impact on Xerostomia for Nasopharyngeal Carcinoma Patients Treated With or Without Superficial Parotid Lobe-sparing Intensity-modulated Radiotherapy

Phase 2

Completed

• Conditions: Radiation-induced Xerostomia; Nasopharyngeal Carcinoma
• Interventions: Radiation: superficial parotid lobe-sparing intensity-modulated radiotherapy

• Registration Number: NCT05020067
• Lead Sponsor: Sun Yat-sen University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-12
• Primary Completion: 2019-11-06
• Status Verified: 2021-08
• Study Completion: 2021-08-17
• Study First Submitted: 2021-08-20
• Study First Submitted QC: 2021-08-24
• Last Update Submitted: 2021-08-24
• Study First Posted: 2021-08-25
• Last Update Posted: 2021-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SPLS-IMRT	superficial 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%

Primary Outcome Measures

Name	Time	Method
the incidence of xerostomia	12 months	the incidence of xerostomia at 12m post-RT based on Radiation Therapy Oncology Group (RTOG) criteria

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China