Dexamethasone in Reducing Oral Pain and Dry Mouth After Surgery in Patients With Oropharyngeal Cancer
This study is currently recruiting participants.
Verified December 2012 by OHSU Knight Cancer Institute
Sponsor:
OHSU Knight Cancer Institute
Information provided by (Responsible Party):
OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
NCT01748942
First received: December 11, 2012
Last updated: December 12, 2012
Last verified: December 2012
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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 | Phase |
|---|---|---|
|
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 |
Procedure: transoral robotic surgery Drug: dexamethasone Drug: placebo |
Phase 2 |
| 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 21 days ] [ 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 21 days ] [ 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.
- Narcotic pain medication usage [ Time Frame: Up to 21 days ] [ 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 21 days ] [ 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 21 days ] [ 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 21 days ] [ Designated as safety issue: No ]Kaplan-Meier curves will be plotted for time to the initiation of oral intake.
- Complications associated with postoperative corticosteroid use after TORS [ Time Frame: Up to 21days ] [ Designated as safety issue: No ]Descriptive statistical analyses will be conducted for a summary of VAS scores at baseline, days 1, 2, 3 and day 7-21 after surgery
| Estimated Enrollment: | 72 |
| Study Start Date: | December 2012 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 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
Other Name: TORS
Drug: dexamethasone
Given IV
Other Name: (11beta,16alpha)-9-fluoro-11
Drug: dexamethasone
Given PO
|
|
Placebo Comparator: 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
Other Name: TORS
Drug: dexamethasone
Given IV
Other Name: (11beta,16alpha)-9-fluoro-11
Drug: placebo
Given PO
Other Name: PLCB
|
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 21 days.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| 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 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
Contacts and Locations
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: Will Stott stottw@ohsu.edu | |
| Principal Investigator: Neil Gross | |
Sponsors and Collaborators
OHSU Knight Cancer Institute
Investigators
| Principal Investigator: | Neil Gross | Oregon Health and Science University |
More Information
No publications provided
| Responsible Party: | OHSU Knight Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT01748942 History of Changes |
| Other Study ID Numbers: | IRB00008071, CPC-12095-L, NCI-2012-02780 |
| Study First Received: | December 11, 2012 |
| Last Updated: | December 12, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Squamous Cell Deglutition Disorders Oropharyngeal Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases Pharyngeal Diseases Otorhinolaryngologic Diseases Pharyngeal Neoplasms Otorhinolaryngologic Neoplasms |
Head and Neck Neoplasms Neoplasms by Site Stomatognathic Diseases Dexamethasone acetate Dexamethasone Dexamethasone 21-phosphate BB 1101 Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 21, 2013