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临床试验/NCT07278557
NCT07278557招募中2 期

Assessment of Sparing Parotid Ducts Via MRI Sialography for Reduced Patient-Reported Xerostomia Following Radiotherapy for Oropharynx Cancer

UNC Lineberger Comprehensive Cancer Center1 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2026年1月28日最近更新:
干预措施

试验速览

阶段
2 期
状态
招募中
入组人数
98
试验地点
1
主要终点
The rate of xerostomia score based on the University of Michigan Xerostomia -6 months Questionnaire - 6 months

研究概览

简要总结

Radiation-induced xerostomia (dry mouth) is one of the most common and severe side effects for patients receiving radiation therapy for head and neck cancer. New approaches are needed to reduce this side effect and improve patients' quality of life after treatment.

This is a Phase II, single-center, double-masked, parallel-arm, randomized controlled trial. It compares MRI-guided parotid ductal sparing to the standard approach of mean parotid gland sparing, focusing on patient-reported dry mouth outcomes in individuals receiving definitive radiotherapy for oropharyngeal cancer.

详细描述

Radiation-induced dry mouth (xerostomia) is the most commonly reported long-term side effect in patients receiving radiation therapy (RT) for head and neck cancer. It occurs when saliva production decreases and the saliva becomes thicker. Patients with xerostomia often have trouble chewing, swallowing, and speaking, and are more likely to develop tooth decay. These problems can significantly lower a patient's quality of life-and the impact tends to get worse over time.

The most common way to reduce radiation-related dry mouth is by limiting the average radiation dose to the parotid glands (which produce saliva). However, this is often not possible because of the patient's anatomy, and many patients still report moderate to severe symptoms long after treatment.

To reduce side effects, some studies have tested giving a lower radiation dose (60Gy instead of the usual 70Gy) in patients with low-risk, HPV-associated tumors. While this has helped improve overall symptoms, xerostomia still remains the most severe and persistent problem reported by patients.

New strategies are needed to better protect patients from radiation-related dry mouth and help maintain their quality of life after treatment. Recent research shows that the parotid gland does not respond evenly to radiation; certain areas, especially large salivary ducts where stem/progenitor cells live, may be key for recovery after damage. If these ducts can be located during treatment planning, the radiation dose to them could be reduced.

A pilot study showed that using MRI sialography to identify the parotid ducts and plan radiation therapy around them is both possible and promising. Patients who received this type of duct-sparing RT had fewer moderate-to-severe dry mouth symptoms compared to patients treated with standard RT (46% vs. 71% at 6 months, and 36% vs. 50% at 12 months post-treatment).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Care Provider)

盲法说明

This study is double-masked, ensuring that both treating physicians and study participants are masked to treatment assignment.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • To participate in this study a subject must meet all of the eligibility criteria outlined below. Eligibility must be maintained for the subject to be considered eligible for ongoing trial participation.
  • Provide written informed consent to participate in the study and HIPAA authorization for release of personal health information.
  • Able to comply with study procedures based on the judgment of the clinical investigator.
  • Male or female, aged ≥ 18 years at the time of consent.
  • Eastern Cooperative Oncology Group performance status 0-2 at the time of consent.
  • Women of reproductive potential must use highly effective contraception.
  • T0-4, N0-3, M0 stage cancer of the oropharynx (American Joint Committee on Cancer Staging System 8th edition) planned for definitive radiotherapy +/- chemotherapy.
  • No contraindications for magnetic resonance imaging (MRI).

排除标准

  • An individual who meets any of the following criteria will be excluded from participation
  • In this study:
  • Patients with Sjogren's disease or baseline xerostomia.
  • Patients with lesions involving the salivary glands on diagnostic imaging
  • Patients with an allergy to lemon juice
  • Prior lifetime history of radiation therapy to the head and neck
  • Current pregnancy or lactation.

研究组 & 干预措施

Experimental Arm

Experimental

Participants randomized to this arm will have their organs-at-risk include the expanded parotid ducts. Treatment planning will aim to explicitly minimize the dose to these structures. If achieving this dose is not possible, it will be documented as a study deviation, but treatment will proceed.

干预措施: MRI sialography (Device)

Experimental Arm

Experimental

Participants randomized to this arm will have their organs-at-risk include the expanded parotid ducts. Treatment planning will aim to explicitly minimize the dose to these structures. If achieving this dose is not possible, it will be documented as a study deviation, but treatment will proceed.

干预措施: Parotid Duct Sparing Radiation Therapy Planning (Other)

Standard Arm

Active Comparator

Participants in this arm will undergo treatment planning using the overall parotid gland volume as the organ-at-risk, following the standard clinical practice. Entire parotid gland will be considered, not the parotid ducts.

干预措施: MRI sialography (Device)

Standard Arm

Active Comparator

Participants in this arm will undergo treatment planning using the overall parotid gland volume as the organ-at-risk, following the standard clinical practice. Entire parotid gland will be considered, not the parotid ducts.

干预措施: Parotid Sparing Radiation Therapy Planning (Other)

结局指标

主要结局

The rate of xerostomia score based on the University of Michigan Xerostomia -6 months Questionnaire - 6 months

时间窗: 6 months

The rate of xerostomia score based on the University of Michigan Xerostomia Questionnaire (UMXQ) will be determined. UMXQ is an eight-item patient-reported instrument designed to assess the severity of xerostomia (dry mouth), gauging symptoms both during and outside of eating or chewing. The score ranges from 0 to 100, with higher scores indicating worse xerostomia. Participants treated with parotid ductal sparing radiotherapy will be compared.

次要结局

  • Salivary flow unstimulated(at 6 and 12 months)
  • Salivary flow stimulated(at 6 and 12 months)
  • The rate of xerostomia score based on the University of Michigan Xerostomia Questionnaire- 12 months(12 months)
  • The rate of xerostomia score based on the MD Anderson Symptom Inventory Head and Neck (MDASI - HN)- 12 months(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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