N/A
N=76
Dexamethasone in Reducing Oral Pain and Dry Mouth After Surgery in Patients With Oropharyngeal Cancer
Dysphagia · Pain · Stage I Oropharyngeal Squamous Cell Carcinoma · Stage II Oropharyngeal Squamous Cell Carcinoma · Stage III Oropharyngeal Squamous Cell Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT01748942 ↗Enrolled (actual)
76
Serious AEs
25.0%
Results posted
Sep 2017
Primary outcome: Primary: Pain Visual Analogue Scale (VAS) Score Measured at 10-point Scale — 7.4; 6.8; 6.0; 6.4 units on a scale — p=0.25
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Dexamethasone (Drug); Placebo (Other); Quality-of-Life Assessment (Procedure); Questionnaire Administration (Other); Transoral Robotic Surgery (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- OHSU Knight Cancer Institute
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Visual Analogue Scale (VAS) Score Measured at 10-point Scale |
7.4; 6.8; 6.0; 6.4; 5.3; 6.7 | 0.25 |
| SECONDARY Complications Associated With Postoperative Corticosteroid Use After TORS |
10; 7; 25; 26 | — |
| SECONDARY Eating Assessment Tool (EAT)-10 Scores |
20.0; 20.2 | — |
| SECONDARY Length of Hospital Stay (Number of Days Between the Date of Surgery and Date of Discharge) |
5; 4 | <0.001 sig |
| SECONDARY PSS Normalcy of Diet |
51.7; 36.7 | 0.009 sig |
| SECONDARY Opioid Use |
137.1; 147.3 | 0.33 |
| SECONDARY UM-QOL Eating |
59.3; 60.1 | 0.96 |
| SECONDARY Days With Feeding Tube |
4; 11 | 0.15 |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01748942). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.