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A Randomized, Placebo Controlled, Double Blinded Study of Corticosteroid Treatment for the Reduction of Postoperative Pain Following Transoral Robotic Surgery


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Dysphagia, Pain, Recurrent Squamous Cell Carcinoma of the Oropharynx, Stage I Squamous Cell Carcinoma of the Oropharynx, Stage II Squamous Cell Carcinoma of the Oropharynx, Stage III Squamous Cell Carcinoma of the Oropharynx

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Trial Information

A Randomized, Placebo Controlled, Double Blinded Study of Corticosteroid Treatment for the Reduction of Postoperative Pain Following Transoral Robotic Surgery


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 21 days.


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 3A4 (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

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Outcome Measure:

Pain visual analogue scale (VAS) score measured at 10-point scale

Outcome Description:

It will be measured at five time points (baseline, days 1, 2, 3 and 7-21 days after surgery). A descriptive time plot of VAS scores will be produced for all enrolled subjects, with loess curve fitted separately for the experimental and control groups. A linear mixed effects model will be used to compare the pain VAS scores between the experimental and control groups.

Outcome Time Frame:

Up to 21 days

Safety Issue:

No

Principal Investigator

Neil Gross

Investigator Role:

Principal Investigator

Investigator Affiliation:

Oregon Health and Science University

Authority:

United States: Food and Drug Administration

Study ID:

IRB00008071

NCT ID:

NCT01748942

Start Date:

December 2012

Completion Date:

Related Keywords:

  • Dysphagia
  • Pain
  • Recurrent Squamous Cell Carcinoma of the Oropharynx
  • Stage I Squamous Cell Carcinoma of the Oropharynx
  • Stage II Squamous Cell Carcinoma of the Oropharynx
  • Stage III Squamous Cell Carcinoma of the Oropharynx
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Deglutition Disorders
  • Oropharyngeal Neoplasms

Name

Location

OHSU Knight Cancer InstitutePortland, Oregon  97239