Dexamethasone in Reducing Oral Pain and Dry Mouth After Surgery in Patients With Oropharyngeal Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2015 by OHSU Knight Cancer Institute
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
NCT01748942
First received: December 11, 2012
Last updated: December 8, 2015
Last verified: November 2015
  Purpose
This randomized clinical trial studies dexamethasone in reducing oral pain and dry mouth after surgery in patients with oral cancer. Dexamethasone may help lower pain and dry mouth caused by surgery.

Condition Intervention
Dysphagia
Pain
Recurrent Oropharyngeal Squamous Cell Carcinoma
Stage I Oropharyngeal Squamous Cell Carcinoma
Stage II Oropharyngeal Squamous Cell Carcinoma
Stage III Oropharyngeal Squamous Cell Carcinoma
Procedure: Transoral Robotic Surgery
Drug: Dexamethasone
Other: Placebo
Procedure: Quality-of-Life Assessment
Other: Questionnaire Administration

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: A Randomized, Placebo Controlled, Double Blinded Study of Corticosteroid Treatment for the Reduction of Postoperative Pain Following Transoral Robotic Surgery

Resource links provided by NLM:


Further study details as provided by OHSU Knight Cancer Institute:

Primary Outcome Measures:
  • Pain visual analogue scale (VAS) score measured at 10-point scale [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Eating Assessment Tool (EAT)-10 scores [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    A descriptive time plot will be produced for EAT-10 scores using baseline and postoperative measurements on days 3 and day 7-21. Descriptive statistical analyses will be conducted for a summary of EAT-10 scores at baseline, days 3 and day 7-21 after surgery. A linear mixed effects model will be used to compare the EAT-10 scores between the two groups.

  • Length of hospital stay (number of days between the date of surgery and date of discharge) [ Time Frame: Up to 21 days ] [ Designated as safety issue: No ]
    Kaplan-Meier functions will be fitted to compare the length of hospital stay between the experimental and control groups.

  • Complications associated with postoperative corticosteroid use after TORS [ Time Frame: Up to 21 days ] [ Designated as safety issue: No ]
    A descriptive statistical analysis will be conducted on complications.

  • Narcotic pain medication usage [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    A descriptive statistical analysis will be conducted on narcotic pain medication use. A summary of these secondary endpoints will be reported separately for the experimental and control groups.

  • Type of diet tolerated [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    A descriptive statistical analysis will be conducted on type of diet tolerance. A summary of these secondary endpoints will be reported separately for the experimental and control groups.

  • Need for tube feeds [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    A descriptive statistical analysis will be conducted on the need for tube feeds. A summary of these secondary endpoints will be reported separately for the experimental and control groups.

  • Time to the initiation of oral intake [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    Kaplan-Meier curves will be plotted for time to the initiation of oral intake.


Estimated Enrollment: 72
Study Start Date: December 2012
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (treatment)
Patients receive dexamethasone IV at the time of surgery and PO every 8 hours for up to 4 days following surgery.
Procedure: Transoral Robotic Surgery
Undergo TORS
Drug: Dexamethasone
Given IV
Other Name: DM
Drug: Dexamethasone
Given PO
Other Name: DM
Procedure: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Active Comparator: Arm II (control)
Patients receive dexamethasone IV at the time of surgery and placebo PO every 8 hours for up to 4 days following surgery.
Procedure: Transoral Robotic Surgery
Undergo TORS
Drug: Dexamethasone
Given IV
Other Name: DM
Other: Placebo
Given PO
Other Name: PLCB
Procedure: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01748942

Locations
United States, Oregon
OHSU Knight Cancer Institute Recruiting
Portland, Oregon, United States, 97239
Contact: Daniel R. Clayburgh    503-494-5355    clayburg@ohsu.edu   
Principal Investigator: Daniel R. Clayburgh         
Sponsors and Collaborators
OHSU Knight Cancer Institute
National Cancer Institute (NCI)
Investigators
Principal Investigator: Daniel Clayburgh OHSU Knight Cancer Institute
  More Information

Responsible Party: OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT01748942     History of Changes
Other Study ID Numbers: 8071  NCI-2012-02780  CPC-12095-L  CR00021919  8071  P30CA069533 
Study First Received: December 11, 2012
Last Updated: December 8, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Deglutition Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 27, 2016