Clinical trial · Interventional
Sparing Parotid Ducts Via MRI Sialography for Reduced Patient-Reported Xerostomia
Assessment of Sparing Parotid Ducts Via MRI Sialography for Reduced Patient-Reported Xerostomia Following Radiotherapy for Oropharynx Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRI sialography | Device | — | UNRESOLVED |
| Parotid Duct Sparing Radiation Therapy Planning | Other | — | UNRESOLVED |
| Parotid Sparing Radiation Therapy Planning | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental Arm
- description
- 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.
- interventionNames
- Device: MRI sialography
- Other: Parotid Duct Sparing Radiation Therapy Planning
- type
- ACTIVE_COMPARATOR
- label
- Standard Arm
- description
- 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.
- interventionNames
- Device: MRI sialography
- Other: Parotid Sparing Radiation Therapy Planning
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 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). Exclusion Criteria: 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.
References
Publications (0)
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