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

August 24, 2021 updated by: Zhao Chong, Sun Yat-sen University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Sun Yat-sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SPLS-IMRT
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%
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%.
No Intervention: C-IMRT
The entire parotid gland was delineated as an OAR, and V36 (the percentage volume receiving 36 Gy or more) in the entire parotid gland was constrained to be less than 40%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the incidence of xerostomia
Time Frame: 12 months
the incidence of xerostomia at 12m post-RT based on Radiation Therapy Oncology Group (RTOG) criteria
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: 36 months
36 months
xerostomia questionnaire score
Time Frame: 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.
12 months
Salivary flow rate
Time Frame: 12 months
unstimulated salivary flow rateand stimulated salivary flow rate
12 months
locoregional relapse-free survival
Time Frame: 36 months
36 months
distant metastasis-free survival
Time Frame: 36 months
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2018

Primary Completion (Actual)

November 6, 2019

Study Completion (Actual)

August 17, 2021

Study Registration Dates

First Submitted

August 20, 2021

First Submitted That Met QC Criteria

August 24, 2021

First Posted (Actual)

August 25, 2021

Study Record Updates

Last Update Posted (Actual)

August 25, 2021

Last Update Submitted That Met QC Criteria

August 24, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPLS-IMRT NPC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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