Total LaryngectomyPhase 2NCT07919821
Early Feeding TL Trial
A Phase 2 study testing oral intake in people with Total Laryngectomy, run by University of Florida at 1 site in United States.
Trial summary
This is a randomized, single-center phase 2 study comparing early versus delayed oral feeding after total laryngectomy. Dysphagia-related outcomes will be assessed using the MDADI preoperatively, and on postoperative days 14 (±7) and 30 (±7). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Laryngectomy
- What is being tested?
- oral intake
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Dec 2026to 16 Jun 2030
- Phase
- Phase 2
- 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
- Subjects who have elected to undergo total laryngectomy surgery
- Subjects receiving free-tissue transfer regardless of indication for total laryngectomy
- Subjects who are English and/or Spanish speaking.
- Written informed consent obtained from the subject and the subject agrees to comply with all the study-related procedures.
Who cannot join
- Subjects who have undergone prior major head and neck surgery or radiation therapy involving the larynx (also referred to as surgical salvage patients).
- History of severe dysphagia or with current enteral feeding needs
- Subjects with intraoperative findings of incomplete mucosal closure judged by the operating surgeon to place the patient at risk for breakdown
- Subjects with evidence of flap ischemia or venous congestion on immediate postoperative assessment
- Subjects with uncontrolled post-operative bleeding from reconstruction site.
- Subjects with gross oropharyngeal contamination or infections noted at the time of surgery.
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- Subjects with other intraoperative findings, at the surgeon's discretion, that would preclude safe participation in the study.
- Subjects who are confirmed to be pregnant or breastfeeding.
- Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.
- History of any other disease, metabolic dysfunction, clinical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician.
- Including pre-existing conditions that put them at risk for poor wound healing, including: scleroderma, active AIDS (CD4 count <200 or not on HAART therapy), autoimmune disease, organ transplant patients on immunosuppressive medications.
- Including a history of traumatic brain injury, stroke, or dementia.
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
University of Florida
Gainesville, Florida, 32610
Ana Leyser, 352-273-5581, aleyser@ufl.edu
Laura Mallinson, (352) 265-5125, coppola@ufl.edu
About this study
Official title: Evaluation of Safety and Outcomes of Early Oral Feeding Following Total Laryngectomy
This is a randomized, single-center phase 2 study comparing early versus delayed oral feeding after total laryngectomy. Dysphagia-related outcomes will be assessed using the MDADI preoperatively, and on postoperative days 14 (±7) and 30 (±7). Secondary outcomes include fistula requiring intervention, surgical site infection, wound dehiscence, oral feeding tolerance, feeding tube duration, nasogastric tube removal, length of stay, PSS-HN scores, and patient-reported oral rehabilitation.
- Conditions
- Total Laryngectomy
- Being tested
- oral intake
- Keywords
- Dysphagia; oral feeding; otolaryngology; pharyngocutaneous fistulas; total laryngectomy; wound dehiscence
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral intakeOther
Subjects will begin oral intake post-op day 1
| Study group | Role | What they receive |
|---|---|---|
| Early Oral Feeding | Experimental | Subjects assigned to Arm 1 will begin oral intake on post-operative day 1 after their standard-of-care total laryngectomy surgery. Receives: Other: oral intake |
| Delayed Oral Feeding | No intervention | Subjects assigned to the delayed feeding protocol will begin oral intake on post-operative day 6 after their standard-of-care total laryngectomy surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early oral feeding versus delayed oral feeding.
Comparison of dysphagia-related outcomes in patients who have received early versus delayed oral feeding pre-operatively (if available)
Measured: post-operative days 14 (± 7 days) and 30 (± 7 days).
MD Anderson Dysphagia Inventory (MDADI) total score
Questionnaire: Assess dysphagia's effects on the quality of life (QOL) of patients with head and neck cancer.
Measured: post-operative days 14 (± 7 days) and 30 (± 7 days).
Summary measure
Difference in mean MDADI scores between groups over time,
Measured: post-operative days 14 (± 7 days) and 30 (± 7 days).
Secondary outcomes (7)
Pharyngocutaneous fistulas
Proportion of patients who develop postoperative complications requiring invasive intervention (surgical or bedside) . salivary leak,
Measured: within 30 days of surgery
Surgical site infections
Proportion of patients who develop postoperative complications requiring invasive intervention (surgical or bedside) .
Measured: within 30 days of surgery
Wound dehiscence
Postoperative complications proportion of patients who develop postoperative complications requiring invasive intervention (surgical or bedside) .
Measured: within 30 days of surgery
Length of stay
Hospital-based metrics documented in the electronic medical record.
Measured: within 30 days of surgery
Enteral feeding duration
Hospital-based metrics documented in the electronic medical record.
Measured: within 30 days of surgery
Rate of oral tolerance
Hospital-based metrics documented in the electronic medical record.
Measured: within 30 days of surgery
Performance Status Scale for Head and Neck Cancer
Clinician-rated assessment tool. Each subscale is scored from 0 to 100, where 100 represents the best possible performance or normalcy of function, and lower scores reflect greater impairment.
Measured: within 30 days of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start16 Dec 2026 (estimated)
- Primary completion16 Jun 2029 (estimated)
- Study completion16 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total LaryngectomyStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Austin Lam, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07919821
- Sponsor's protocol ID
- UF-HN-006
- Other IDs
- IRB202401711
- Status last verified
- Oct 2026
- First submitted
- 30 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety and Outcomes of Early Oral Feeding Following Total Laryngectomy
- ClinicalTrials.gov ID
- NCT07919821
- Acronym / sponsor ID
- UF-HN-006
- Conditions
- Total Laryngectomy
- Keywords
- Dysphagia; oral feeding; otolaryngology; pharyngocutaneous fistulas; total laryngectomy; wound dehiscence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 16 Dec 2026 (estimated)
- Primary completion
- 16 Jun 2029 (estimated)
- Study completion
- 16 Jun 2030 (estimated)
- First posted
- 5 Nov 2026 (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.
This is a randomized, single-center phase 2 study comparing early versus delayed oral feeding after total laryngectomy. Dysphagia-related outcomes will be assessed using the MDADI preoperatively, and on postoperative days 14 (±7) and 30 (±7). Secondary outcomes include fistula requiring intervention, surgical site infection, wound dehiscence, oral feeding tolerance, feeding tube duration, nasogastric tube removal, length of stay, PSS-HN scores, and patient-reported oral rehabilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Oral Feeding | Experimental | Other: oral intakeSubjects assigned to Arm 1 will begin oral intake on post-operative day 1 after their standard-of-care total laryngectomy surgery. |
| Delayed Oral Feeding | No intervention | –Subjects assigned to the delayed feeding protocol will begin oral intake on post-operative day 6 after their standard-of-care total laryngectomy surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects who have elected to undergo total laryngectomy surgery
- Subjects receiving free-tissue transfer regardless of indication for total laryngectomy
- Subjects who are English and/or Spanish speaking.
- Written informed consent obtained from the subject and the subject agrees to comply with all the study-related procedures.
Key exclusion criteria (12 listed)
- Subjects who have undergone prior major head and neck surgery or radiation therapy involving the larynx (also referred to as surgical salvage patients).
- History of severe dysphagia or with current enteral feeding needs
- Subjects with intraoperative findings of incomplete mucosal closure judged by the operating surgeon to place the patient at risk for breakdown
- Subjects with evidence of flap ischemia or venous congestion on immediate postoperative assessment
- Subjects with uncontrolled post-operative bleeding from reconstruction site.
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 |
|---|---|---|
| oral intakeSubjects will begin oral intake post-op day 1 | Other | Early Oral Feeding |
Primary outcome
Early oral feeding versus delayed oral feeding.
Time frame: post-operative days 14 (± 7 days) and 30 (± 7 days).
Comparison of dysphagia-related outcomes in patients who have received early versus delayed oral feeding pre-operatively (if available)
MD Anderson Dysphagia Inventory (MDADI) total score
Time frame: post-operative days 14 (± 7 days) and 30 (± 7 days).
Questionnaire: Assess dysphagia's effects on the quality of life (QOL) of patients with head and neck cancer.
Summary measure
Time frame: post-operative days 14 (± 7 days) and 30 (± 7 days).
Difference in mean MDADI scores between groups over time,
7 secondary outcomes
Pharyngocutaneous fistulas
Time frame: within 30 days of surgery
Surgical site infections
Time frame: within 30 days of surgery
Wound dehiscence
Time frame: within 30 days of surgery
Length of stay
Time frame: within 30 days of surgery
Enteral feeding duration
Time frame: within 30 days of surgery
Rate of oral tolerance
Time frame: within 30 days of surgery
Performance Status Scale for Head and Neck Cancer
Time frame: within 30 days of surgery
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 5 Nov 2026.
- Individual participant dataSharing planned: Undecided
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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.
Austin Lam, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing oral intake in people with Total Laryngectomy, run by University of Florida 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 4 inclusion and 12 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: opening soon, as of the sponsor's last update on 5 Nov 2026. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Ana Leyser ((352) 273-5581, aleyser@ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early oral feeding versus delayed oral feeding. (time frame: post-operative days 14 (± 7 days) and 30 (± 7 days).). The study lists 3 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 5 Nov 2026.