Clinical trial · Interventional
Dexamethasone in Reducing Oral Pain and Dry Mouth After Surgery in Patients With Oropharyngeal Cancer
A Randomized, Placebo Controlled, Double Blinded Study of Corticosteroid Treatment for the Reduction of Postoperative Pain Following Transoral Robotic Surgery
NCT01748942CI-TRIAL-00033343completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This randomized pilot clinical trial studies dexamethasone in reducing oral pain and dry mouth after surgery in patients with oropharyngeal cancer. Dexamethasone may help lower pain and dry mouth caused by surgery.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Dysphagia | — | UNRESOLVED | — |
| Pain | — | UNRESOLVED | — |
| Stage III Oropharyngeal Squamous Cell Carcinoma | Oropharyngeal Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
| Stage II Oropharyngeal Squamous Cell Carcinoma | Oropharyngeal Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
| Stage I Oropharyngeal Squamous Cell Carcinoma | Oropharyngeal Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Placebo | Other | — | UNRESOLVED |
| Quality-of-Life Assessment | Procedure | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
| Transoral Robotic Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (treatment)
- description
- Patients receive dexamethasone IV at the time of surgery and PO every 8 hours for up to 4 days following surgery.
- interventionNames
- Drug: Dexamethasone
- Procedure: Quality-of-Life Assessment
- Other: Questionnaire Administration
- Procedure: Transoral Robotic Surgery
- type
- ACTIVE_COMPARATOR
- label
- Arm II (control)
- description
- Patients receive dexamethasone IV at the time of surgery and placebo PO every 8 hours for up to 4 days following surgery.
- interventionNames
- Drug: Dexamethasone
- Other: Placebo
- Procedure: Quality-of-Life Assessment
- Other: Questionnaire Administration
- Procedure: Transoral Robotic Surgery
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must be diagnosed with oropharyngeal squamous cell carcinoma (SCC) that are surgical candidates * Macroscopic resection of the tumor via TORS must be planned with curative intent * Patient must be willing to remain on corticosteroid therapy for 4 days postoperatively * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Patients with known distant metastases or other malignancies * Patients with a history of allergy or adverse reaction to corticosteroids * Patients with a history of diabetes * Patients with fasting capillary blood glucose of \> 140 on the day of surgery * Patients on chronic corticosteroids * Chronic alcohol abuse (\> 6 alcoholic beverages daily) * Patients with a history of severe chronic pain on high dose narcotics (\> 25 mg of oxycodone or equivalent daily) preceding diagnosis of cancer * Patients taking significant cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors or inducers, i.e. protease inhibitors (ritonavir, nelfinavir, etc), clarithromycin, ketoconazole, fluconazole, verapamil, diltiazem, carbamazepine, phenytoin, phenobarbital, Rifampin, efavirenz, nevirapine * Patients who have received any investigational medication within 6 weeks of enrollment, or who are scheduled to receive an investigational drug during the course of the study * Patients who will undergo complex head and neck surgery in addition to the TORS procedure requiring reconstruction with a free flap * Patients who have had any previous head and neck surgery that has affected swallowing, voice or speech or who have had previous radiation to the head or neck * Patients who have any confounding medical or neurological conditions that have the potential to affect cognition, speech or swallowing function; i.e. stroke, neurodegenerative disease, neuromuscular movement disorders, head injury, etcetera * Psychiatric illness/social situations that would limit compliance with study requirements * Excluded patients will be allowed to participate in the trial on an observational basis only
References
Publications (1)
- DERIVEDClayburgh D, Stott W, Bolognone R, Palmer A, Achim V, Troob S, Li R, Brickman D, Graville D, Andersen P, Gross ND. A randomized controlled trial of corticosteroids for pain after transoral robotic surgery. Laryngoscope. 2017 Nov;127(11):2558-2564. doi: 10.1002/lary.26625. Epub 2017 Aug 29. PMID 28850681