Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2025-12-25 @ 1:48 PM
Study NCT ID:
NCT07227792
Status:
RECRUITING
Last Update Posted:
2025-12-17
First Post:
2025-11-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Tongue-out Radiation Therapy (TORT) for the Mitigation of Radiotherapy-related Toxicities in Patients With Head and Neck Cancer
Sponsor:
Yvonne Mowery
Organization:
Study Overview
Official Title:
Tongue-out Radiation Therapy (TORT) for the Mitigation of Radiotherapy-related Toxicities in Patients With Head and Neck Cancer
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Our institution recently began incorporating a novel "tongue-out" radiation therapy (TORT) technique for patients with head and neck tumors at particular subsites (oropharynx, larynx, hypopharynx). Protruding the tongue, i.e. "tongue-out" position, induces anatomical changes that facilitate decreased radiation dose to the oral tongue and PCM. The long-term goal is to determine whether TORT results in reduced severity and faster recovery from acute treatment-related toxicities (particularly mucositis, dysphagia, and dysgeusia) and improved long-term swallowing function and taste compared to traditional "tongue-in" RT for patients with HNC.
Detailed Description:
Despite good disease control and organ preservation outcomes after radiotherapy (RT) for head and neck cancers (HNC), particularly human papillomavirus (HPV)-related oropharyngeal cancer, treatment-related toxicities remain a challenging survivorship problem. Impaired calorie intake due to common RT-associated toxicities such as mucositis, dysphagia (difficulty swallowing), and dysgeusia (taste loss) can lead to treatment breaks that reduce treatment efficacy and prolong recovery, some of which persist long-term and negatively impact quality of life (QOL). Radiation doses to the pharyngeal constrictor muscles (PCM) and oral tongue correlate with incidence and severity of dysphagia and dysgeusia. Doses to the pharyngeal and oral tongue mucosa are associated with incidence and severity of mucositis. "Tongue-out" radiation therapy (TORT) is a treatment positioning technique for patients with head and neck tumors at particular subsites (e.g., oropharynx, larynx, hypopharynx). Protruding the tongue, i.e. "tongue-out" position, during pre-treatment simulation and subsequent treatment induces anatomical changes that facilitate decreased radiation dose to the oral tongue and PCM. TORT for oropharyngeal, laryngeal, and hypopharyngeal cancers may result in significantly lower radiation dose to the PCM and oral tongue compared to "tongue-in" RT, and that this reduced dose to organs at risk (OARs) will yield clinically meaningful improvements in severity and duration of dysphagia, dysgeusia, and mucositis.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: