Clinical trial NCT01748942: Dexamethasone in Reducing Oral Pain and Dry Mouth After Surgery in Patients With Oropharyngeal Cancer
Official title: A Randomized, Placebo Controlled, Double Blinded Study of Corticosteroid Treatment for the Reduction of Postoperative Pain Following Transoral Robotic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dysphagia
Pain
Stage I Oropharyngeal Squamous Cell Carcinoma
Stage II Oropharyngeal Squamous Cell Carcinoma
Stage III Oropharyngeal Squamous Cell Carcinoma
Lead sponsor: OHSU Knight Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-12-13
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: PRIMARY OBJECTIVES:

I. To prospectively determine if a longer 4-day course of dexamethasone (or equivalent) for the management of postoperative pain and dysphagia following transoral robotic surgery (TORS) is superior to the current standard of a single injection of dexamethasone 10 mg.

SECONDARY OBJECTIVES:

I. Determine the effect of postoperative corticosteroids on postoperative dysphagia following TORS.

II. Determine the effect of postoperative corticosteroids on length of hospital stay following TORS.

III. Determine the complications associated with postoperative corticosteroid use after TORS.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive dexamethasone intravenously (IV) at the time of surgery and orally (PO) every 8 hours for up to 4 days following surgery.

ARM II: Patients receive dexamethasone IV at the time of surgery and placebo PO every 8 hours for up to 4 days following surgery.

After completion of study treatment, patients are followed up for up to 12 months.

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

Primary outcomes:
measure: Pain Visual Analogue Scale (VAS) Score Measured at 10-point Scale
timeFrame: 21 days
Secondary outcomes:
measure: Complications Associated With Postoperative Corticosteroid Use After TORS
timeFrame: Up to 30 days
measure: Eating Assessment Tool (EAT)-10 Scores
timeFrame: Up to 12 months
measure: Length of Hospital Stay (Number of Days Between the Date of Surgery and Date of Discharge)
timeFrame: Up to 21 days
measure: PSS Normalcy of Diet
timeFrame: 30 days
measure: Opioid Use
timeFrame: 3 days
measure: UM-QOL Eating
timeFrame: 21 days
measure: Days With Feeding Tube
timeFrame: 12 months
Other outcomes:
Locations:
city: Portland
country: United States
facility: OHSU Knight Cancer Institute
state: Oregon
Study officials:
affiliation: OHSU Knight Cancer Institute
name: Daniel Clayburgh
role: PRINCIPAL_INVESTIGATOR
References:
citation: Clayburgh 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.