Head and Neck CarcinomaNCT07227792
Tongue-out Radiation Therapy (TORT) for the Mitigation of Radiotherapy-related Toxicities in Patients With Head and Neck Cancer
A study testing Tongue-out radiation therapy (TORT) in people with Head and Neck Carcinoma, run by Yvonne Mowery at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Carcinoma
- What is being tested?
- Tongue-out radiation therapy (TORT)
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Nov 2025to 31 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must have histologically or cytologically confirmed squamous cell carcinoma of the oropharynx, larynx, or hypopharynx (cT0-4, N0-3, M0-1).
- Patients with metastatic disease will be included if the following criteria are met:
- Definitive RT dose is planned for the primary site
- The number of metastatic lesions is ≤5
- All metastatic lesions are confined to a single organ (e.g., lung)
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2
Show all 14Show fewer
- Female subjects of childbearing potential must not be pregnant or breastfeeding at screening.
- Female subjects are considered to be of childbearing potential unless one of the following criteria is met:
- o Permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausal status (defined as 12 months of amenorrhea in a woman > 45 years-of-age in the absence of other biological or physiological causes. Note: Documentation may include review of medical records, medical examination, or medical history interview by study site staff.
- Female subjects of childbearing potential must utilize an appropriate method of birth control such as hormonal methods (oral, injectable, implant, skin patch, vaginal ring), intrauterine devices, barrier methods (consistent use of male/female condoms, diaphragms, cervical caps), surgical methods (vasectomy, tubal ligation), or true abstinence.
- Must be able to comfortably protrude tongue in the treatment position for at least 1 minute.
- Must have the ability to understand and the willingness to sign a written informed consent document.
- Must be willing to comply with all study procedures.
- Must be able to complete patient-reported outcome (PRO) questionnaires in English.
Who cannot join
- Patients with T1-T2 N0 glottic cancer (i.e., planned to undergo RT to the larynx only)
- Posterior pharyngeal wall primary tumor
- Widely metastatic disease
- Surgical resection of the primary tumor
- Induction chemotherapy or immunotherapy prior to planned radiotherapy
- Prior head and neck radiotherapy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Samantha Demko, RN, 412-623-1400, albesl@upmc.edu
Brieanna Marino, MS, 4126478258, rowlesbm@upmc.edu
About this study
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.
Read the 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.
- Conditions
- Head and Neck Carcinoma
- Being tested
- Tongue-out radiation therapy (TORT)
- Keywords
- Tongue-out radiation therapy (TORT), human papillomavirus (HPV)-related oropharyngeal cancer, Intensity modulated radiotherapy (IMRT), volumetric modulated arc therapy (VMAT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tongue-out radiation therapy (TORT)Radiation
The high-risk PTV will contain the primary tumor and any lymph nodes confirmed or suspected to harbor metastatic disease based on imaging findings, pathology reports, and/or clinical exam. Dose to the high-risk PTV must be 70.0 Gy at 2.0 Gy per fraction.
The intermediate-risk PTV will contain areas considered to contain potential microscopic disease in close proximity to the primary tumor (GTV + 10 mm with adjustments per above based on anatomic boundaries or air) and the entire cervical lymph node level(s) corresponding to any lymph nodes confirmed or suspected to harbor metastatic disease. Dose to intermediate-risk PTV must be 63 Gy at 1.8 Gy per fraction.
The low-risk PTV will contain any cervical lymph node levels felt to be potentially harbor microscopic disease but with negative imaging and/or clinical findings. The exact cervical lymph node levels included in the low-risk PTV should be based on Tables 3-5. Dose to the low-risk PTV must be 56 Gy at 1.6 Gy per fraction.
| Study group | Role | What they receive |
|---|---|---|
| Tongue-out radiation therapy (TORT) | Experimental | 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. All patients will be treated with IMRT. All IMRT techniques, including static field IMRT, helical IMRT (Tomotherapy), and VMAT are allowed. Receives: Radiation: Tongue-out radiation therapy (TORT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eating Assessment Tool 10 (EAT-10)
Mean difference in Eating Assessment Tool 10 (EAT-10) total scores between patients enrolled on this prospective study and matched retrospective controls. EAT-10 screens for dysphagia and aspiration risk. Total score ranges 0 - 40. Patients rate each question on a scale of 0 (no problem) to 4 (severe problem) regarding, weight loss, inability to go out for meals, increased swallowing effort, pain while swallowing, reduced pleasure while eating, bolus sensation, coughing, and stress when swallowing. Score of 15 or more means patient is at risk for aspiration. Follow up with a full dysphagia assessment and introduce safe swallowing strategies and a modified diet, as needed. Score of 16 or less means patient may not be at risk for aspiration and follow up with a full dysphagia assessment only if symptomatic.
Measured: At Baseline
Eating Assessment Tool 10 (EAT-10)
Mean difference in Eating Assessment Tool 10 (EAT-10) total scores between patients enrolled on this prospective study and matched retrospective controls. EAT-10 screens for dysphagia and aspiration risk. Total score ranges 0 - 40. Patients rate each question on a scale of 0 (no problem) to 4 (severe problem) regarding, weight loss, inability to go out for meals, increased swallowing effort, pain while swallowing, reduced pleasure while eating, bolus sensation, coughing, and stress when swallowing. Score of 15 or more means patient is at risk for aspiration. Follow up with a full dysphagia assessment and introduce safe swallowing strategies and a modified diet, as needed. Score of 16 or less means patient may not be at risk for aspiration and follow up with a full dysphagia assessment only if symptomatic.
Measured: At 6 weeks post-treatment
Secondary outcomes (7)
Eating Assessment Tool 10 (EAT-10)
Mean difference between EAT-10 scores post-RT for the prospective TORT patients and matched historical controls at this timepoint. EAT-10 screens for dysphagia and aspiration risk. Total score ranges 0 - 40. Patients rate each question on a scale of 0 (no problem) to 4 (severe problem) regarding, weight loss, inability to go out for meals, increased swallowing effort, pain while swallowing, reduced pleasure while eating, bolus sensation, coughing, and stress when swallowing. Score of 15 or more means patient is at risk for aspiration. Follow up with a full dysphagia assessment and introduce safe swallowing strategies and a modified diet, as needed. Score of 16 or less means patient may not be at risk for aspiration and follow up with a full dysphagia assessment only if symptomatic.
Measured: At 58 weeks post treatment
Change in Eating Assessment Tool 10 (EAT-10) Scores
Mean change in EAT-10 scores post-RT for the prospective TORT patients and matched historical controls. EAT-10 screens for dysphagia and aspiration risk. Total score ranges 0 - 40. Patients rate each question on a scale of 0 (no problem) to 4 (severe problem) regarding, weight loss, inability to go out for meals, increased swallowing effort, pain while swallowing, reduced pleasure while eating, bolus sensation, coughing, and stress when swallowing. Score of 15 or more means patient is at risk for aspiration. Follow up with a full dysphagia assessment and introduce safe swallowing strategies and a modified diet, as needed. Score of 16 or less means patient may not be at risk for aspiration and follow up with a full dysphagia assessment only if symptomatic.
Measured: At Baseline and 6 weeks post-treatment
Change in Eating Assessment Tool 10 (EAT-10) Scores
Mean change in EAT-10 scores between for the prospective TORT patients and matched historical controls. EAT-10 screens for dysphagia and aspiration risk. Total score ranges 0 - 40. Patients rate each question on a scale of 0 (no problem) to 4 (severe problem) regarding, weight loss, inability to go out for meals, increased swallowing effort, pain while swallowing, reduced pleasure while eating, bolus sensation, coughing, and stress when swallowing. Score of 15 or more means patient is at risk for aspiration. Follow up with a full dysphagia assessment and introduce safe swallowing strategies and a modified diet, as needed. Score of 16 or less means patient may not be at risk for aspiration and follow up with a full dysphagia assessment only if symptomatic.
Measured: At Baseline and 58 weeks post treatment
University of Washington Quality of Life Questionnaire (UW-QOL)
Mean difference between UW-QOL swallowing scores post-RT for the prospective TORT patients and matched historical controls at this timepoint. Self-administered UW-QOL measures health and quality of life over prior 7 days. 12 domain-specific questions include a patient's evaluation of the following: pain, appearance, activity, recreation, swallowing, chewing, speech, shoulder, taste, saliva, mood, and anxiety. The UW-QOL domains are based upon discrete ordinal responses. Scoring is scaled to so that a score of 0 represents the worst possible response, and a score of 100 represents the best possible response. Scoring is scaled in equal stages from 0 to 100 to reflect the number of possible responses.
Measured: At 6 weeks post-treatment
Change in QoL per University of Washington Quality of Life Questionnaire (UW-QOL)
Mean change in UW-QOL swallowing scores for the prospective TORT patients and matched historical controls. Self-administered UW-QOL measures health and quality of life over prior 7 days. 12 domain-specific questions include a patient's evaluation of the following: pain, appearance, activity, recreation, swallowing, chewing, speech, shoulder, taste, saliva, mood, and anxiety. The UW-QOL domains are based upon discrete ordinal responses. Scoring is scaled to so that a score of 0 represents the worst possible response, and a score of 100 represents the best possible response. Scoring is scaled in equal stages from 0 to 100 to reflect the number of possible responses.
Measured: At Baseline and 6 weeks post-treatment
Difference in radiation doses - oral tongue
Mean difference in radiation doses (number of Gy) to the oral tongue as measured in radiation treatment planning software between TORT and non-TORT plans for the same patients.
Measured: Up to 38 months
Difference in radiation doses - pharyngeal
Mean difference in radiation doses (number of Gy) to the pharyngeal constrictors muscles as measured in radiation treatment planning software between TORT and non-TORT plans for the same patients.
Measured: Up to 38 moonths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2025
- Study start23 Nov 2025
- Primary completion30 Nov 2027 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yvonne Mowery
- Sponsor type
- University, hospital or other
- Collaborators
- Radiological Society of North America
- Responsible party
- Sponsor-investigator, Yvonne Mowery, University of Pittsburgh
- Investigators
- Yvonne Mowery, MD, Principal investigator, UPMC Hillman Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07227792
- Sponsor's protocol ID
- HCC 25-085
- Status last verified
- Dec 2025
- First submitted
- 10 Nov 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tongue-out Radiation Therapy (TORT) for the Mitigation of Radiotherapy-related Toxicities in Patients With Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT07227792
- Acronym / sponsor ID
- HCC 25-085
- Conditions
- Head and Neck Carcinoma
- Keywords
- Tongue-out radiation therapy (TORT), human papillomavirus (HPV)-related oropharyngeal cancer, Intensity modulated radiotherapy (IMRT), volumetric modulated arc therapy (VMAT)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Yvonne MoweryUniversity, hospital or other
- Collaborators
- Radiological Society of North America
- Study start
- 23 Nov 2025 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 13 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tongue-out radiation therapy (TORT) | Experimental | Radiation: Tongue-out radiation therapy (TORT)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. All patients will be treated with IMRT. All IMRT techniques, including static field IMRT, helical IMRT (Tomotherapy), and VMAT are allowed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Must have histologically or cytologically confirmed squamous cell carcinoma of the oropharynx, larynx, or hypopharynx (cT0-4, N0-3, M0-1).
- Patients with metastatic disease will be included if the following criteria are met:
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2
- Female subjects of childbearing potential must not be pregnant or breastfeeding at screening.
- o Permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausal status (defined as 12 months of amenorrhea in a woman > 45 years-of-age in the absence of other biological or physiological causes. Note: Documentation may include review of medical records, medical examination, or medical history interview by study site staff.
Key exclusion criteria (6 listed)
- Patients with T1-T2 N0 glottic cancer (i.e., planned to undergo RT to the larynx only)
- Posterior pharyngeal wall primary tumor
- Widely metastatic disease
- Surgical resection of the primary tumor
- Induction chemotherapy or immunotherapy prior to planned radiotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tongue-out radiation therapy (TORT)The high-risk PTV will contain the primary tumor and any lymph nodes confirmed or suspected to harbor metastatic disease based on imaging findings, pathology reports, and/or clinical exam. Dose to the high-risk PTV must be 70.0 Gy at 2.0 Gy per fraction. The intermediate-risk PTV will contain areas considered to contain potential microscopic disease in close proximity to the primary tumor (GTV + 10 mm with adjustments per above based on anatomic boundaries or air) and the entire cervical lymph node level(s) corresponding to any lymph nodes confirmed or suspected to harbor metastatic disease. Dose to intermediate-risk PTV must be 63 Gy at 1.8 Gy per fraction. The low-risk PTV will contain any cervical lymph node levels felt to be potentially harbor microscopic disease but with negative imaging and/or clinical findings. The exact cervical lymph node levels included in the low-risk PTV should be based on Tables 3-5. Dose to the low-risk PTV must be 56 Gy at 1.6 Gy per fraction. | Radiation | Tongue-out radiation therapy (TORT) |
Primary outcome
Eating Assessment Tool 10 (EAT-10)
Time frame: At Baseline
Mean difference in Eating Assessment Tool 10 (EAT-10) total scores between patients enrolled on this prospective study and matched retrospective controls. EAT-10 screens for dysphagia and aspiration risk. Total score ranges 0 - 40. Patients rate each question on a scale of 0 (no problem) to 4 (severe problem) regarding, weight loss, inability to go out for meals, increased swallowing effort, pain while swallowing, reduced pleasure while eating, bolus sensation, coughing, and stress when swallowing. Score of 15 or more means patient is at risk for aspiration. Follow up with a full dysphagia assessment and introduce safe swallowing strategies and a modified diet, as needed. Score of 16 or less means patient may not be at risk for aspiration and follow up with a full dysphagia assessment only if symptomatic.
Eating Assessment Tool 10 (EAT-10)
Time frame: At 6 weeks post-treatment
Mean difference in Eating Assessment Tool 10 (EAT-10) total scores between patients enrolled on this prospective study and matched retrospective controls. EAT-10 screens for dysphagia and aspiration risk. Total score ranges 0 - 40. Patients rate each question on a scale of 0 (no problem) to 4 (severe problem) regarding, weight loss, inability to go out for meals, increased swallowing effort, pain while swallowing, reduced pleasure while eating, bolus sensation, coughing, and stress when swallowing. Score of 15 or more means patient is at risk for aspiration. Follow up with a full dysphagia assessment and introduce safe swallowing strategies and a modified diet, as needed. Score of 16 or less means patient may not be at risk for aspiration and follow up with a full dysphagia assessment only if symptomatic.
7 secondary outcomes
Eating Assessment Tool 10 (EAT-10)
Time frame: At 58 weeks post treatment
Change in Eating Assessment Tool 10 (EAT-10) Scores
Time frame: At Baseline and 6 weeks post-treatment
Change in Eating Assessment Tool 10 (EAT-10) Scores
Time frame: At Baseline and 58 weeks post treatment
University of Washington Quality of Life Questionnaire (UW-QOL)
Time frame: At 6 weeks post-treatment
Change in QoL per University of Washington Quality of Life Questionnaire (UW-QOL)
Time frame: At Baseline and 6 weeks post-treatment
Difference in radiation doses - oral tongue
Time frame: Up to 38 months
Difference in radiation doses - pharyngeal
Time frame: Up to 38 moonths
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yvonne Mowery, MD principal investigator
UPMC Hillman Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tongue-out radiation therapy (TORT) in people with Head and Neck Carcinoma, run by Yvonne Mowery at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samantha Demko, RN (412-623-1400, albesl@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eating Assessment Tool 10 (EAT-10) (time frame: At Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.