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New treatment option for Head and Neck Cancer
Official title Sparing Parotid Ducts Via MRI Sialography for Reduced Patient-Reported Xerostomia
ClinicalTrials.gov ID: NCT07278557
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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.
You likely can't join if
- 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.
See the full eligibility 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).
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Chapel Hill, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chapel Hill, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.