A Phase 2 interventional study of oral intake in Total Laryngectomy, sponsored by University of Florida. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by University of Florida · Phase 2, Interventional, and Treatment
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.
871 studies on the registry are indexed under Deglutition Disorders; 237 are open to participants now.
This study's planned enrollment of 120 is above the median of 60 across 578 interventional studies indexed under Deglutition Disorders.
Browse Deglutition Disorders studies →University of Florida is the lead sponsor of 1,287 studies on the registry; 199 are open to participants now.
Of its 180 completed or terminated interventional studies of FDA-regulated products, 143 (79%) have results posted.
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Exclusion Criteria:
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CD4 count
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects assigned to Arm 1 will begin oral intake on post-operative day 1 after their standard-of-care total laryngectomy surgery.
Other: oral intake
Subjects assigned to the delayed feeding protocol will begin oral intake on post-operative day 6 after their standard-of-care total laryngectomy surgery.
Subjects will begin oral intake post-op day 1
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)
Time frame: 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.
Time frame: post-operative days 14 (± 7 days) and 30 (± 7 days).
Summary measure
Difference in mean MDADI scores between groups over time,
Time frame: post-operative days 14 (± 7 days) and 30 (± 7 days).
Pharyngocutaneous fistulas
Proportion of patients who develop postoperative complications requiring invasive intervention (surgical or bedside) . salivary leak,
Time frame: within 30 days of surgery
Surgical site infections
Proportion of patients who develop postoperative complications requiring invasive intervention (surgical or bedside) .
Time frame: within 30 days of surgery
Wound dehiscence
Postoperative complications proportion of patients who develop postoperative complications requiring invasive intervention (surgical or bedside) .
Time frame: within 30 days of surgery
Length of stay
Hospital-based metrics documented in the electronic medical record.
Time frame: within 30 days of surgery
Enteral feeding duration
Hospital-based metrics documented in the electronic medical record.
Time frame: within 30 days of surgery
Rate of oral tolerance
Hospital-based metrics documented in the electronic medical record.
Time frame: 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.
Time frame: within 30 days of surgery
Plan to share: Undecided
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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