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

Nasopharyngeal Carcinoma Clinical Trial

Official title:

Impact on Xerostomia for Nasopharyngeal Carcinoma Patients Treated With or Without Superficial Parotid Lobe-sparing Intensity-modulated Radiotherapy: a Prospective Phase II Clinical Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05020067
• Other study ID #: SPLS-IMRT NPC
• Status: Completed
• Phase: Phase 2
• Start date: January 12, 2018
• Est. completion date: August 17, 2021

Study information

• Verified date: August 2021
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: August 17, 2021
• Est. primary completion date: November 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma
• Radiation-induced Xerostomia
• Xerostomia

Intervention

Radiation:
• 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%.

Locations

Country	Name	City	State
China	Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the incidence of xerostomia	the incidence of xerostomia at 12m post-RT based on Radiation Therapy Oncology Group (RTOG) criteria	12 months
Secondary	xerostomia questionnaire score	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.	12 months
Secondary	Salivary flow rate	unstimulated salivary flow rateand stimulated salivary flow rate	12 months
Secondary	locoregional relapse-free survival		36 months
Secondary	distant metastasis-free survival		36 months
Secondary	overall survival		36 months

External Links

•   Home Page of Cancer Center, Sun Yat-sen University