Dexamethasone in Reducing Oral Pain and Dry Mouth After Surgery in Patients With Oropharyngeal Cancer
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| ClinicalTrials.gov Identifier: NCT01748942 |
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Recruitment Status :
Completed
First Posted : December 13, 2012
Results First Posted : September 12, 2017
Last Update Posted : June 19, 2018
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Sponsor:
OHSU Knight Cancer Institute
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Daniel Clayburgh, OHSU Knight Cancer Institute
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Dysphagia Pain Stage I Oropharyngeal Squamous Cell Carcinoma Stage II Oropharyngeal Squamous Cell Carcinoma Stage III Oropharyngeal Squamous Cell Carcinoma | Drug: Dexamethasone Other: Placebo Procedure: Quality-of-Life Assessment Other: Questionnaire Administration Procedure: Transoral Robotic Surgery | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 76 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, 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 |
| Study Start Date : | December 2012 |
| Actual Primary Completion Date : | July 2016 |
| Actual Study Completion Date : | March 29, 2017 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Dexamethasone
| Arm | Intervention/treatment |
|---|---|
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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.
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Drug: Dexamethasone
Given IV
Other Names:
Drug: Dexamethasone Given PO
Other Names:
Procedure: Quality-of-Life Assessment Ancillary studies
Other Name: Quality of Life Assessment Other: Questionnaire Administration Ancillary studies Procedure: Transoral Robotic Surgery Undergo TORS
Other Name: TORS |
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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.
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Drug: Dexamethasone
Given IV
Other Names:
Other: Placebo Given PO
Other Names:
Procedure: Quality-of-Life Assessment Ancillary studies
Other Name: Quality of Life Assessment Other: Questionnaire Administration Ancillary studies Procedure: Transoral Robotic Surgery Undergo TORS
Other Name: TORS |
Primary Outcome Measures :
- Pain Visual Analogue Scale (VAS) Score Measured at 10-point Scale [ Time Frame: 21 days ]Visual Analog Scale (VAS) is a 0-10 scale for patients to indicate intensity level of pain with 0 indicating "No pain" and 10 indicating "Worst possible, unbearable, excruciating pain". 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 :
- Complications Associated With Postoperative Corticosteroid Use After TORS [ Time Frame: Up to 30 days ]A descriptive statistical analysis will be conducted on complications.
- Eating Assessment Tool (EAT)-10 Scores [ Time Frame: Up to 12 months ]Statistical Analysis between placebo and steroid cohorts to assess differences. The Eating Assessment Tool (EAT-10) is a 10 item questionnaire that evaluates swallowing and the extent of how problematic with certain eating activities. Questions are answered using a five point (0-4) plus Not Applicable scale with 0 = "No problem" and 4= "Severe problem". 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 ]Kaplan-Meier functions will be fitted to compare the length of hospital stay between the experimental and control groups.
- PSS Normalcy of Diet [ Time Frame: 30 days ]Performance Status Score (PSS) - Normalcy of Diet score is a 0-100 scale that measures diet restrictions with 0= "Non-oral feeding (tube fed)" and 100 = "Full diet (no restrictions)"
- Opioid Use [ Time Frame: 3 days ]
- UM-QOL Eating [ Time Frame: 21 days ]The University of Michigan Head and Neck Quality of Life Questionnaire (UM-QOL) is 20 item, 1-5 scale, questionnaire that measures how much the patient has been bothered during various activities as a result of head and neck condition or treatment in the past four weeks with 1= "Not at all" and 5="Extremely". The scores are calculated using a Likert Scale, which transforms the 1-5 choices into a 0-100 scale with 100 being normal and 0 being poor quality of life. This test contains separate domains (eating, etc.) that can be scored independently. Scores were analyzed between cohorts pre and post operatively.
- Days With Feeding Tube [ Time Frame: 12 months ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01748942
Locations
| United States, Oregon | |
| OHSU Knight Cancer Institute | |
| Portland, Oregon, United States, 97239 | |
Sponsors and Collaborators
OHSU Knight Cancer Institute
National Cancer Institute (NCI)
Investigators
| Principal Investigator: | Daniel Clayburgh | OHSU Knight Cancer Institute |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Daniel Clayburgh, Assistant Professor, OHSU Knight Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT01748942 |
| Other Study ID Numbers: |
IRB00008071 NCI-2012-02780 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) CPC-12095-L CR00021919 IRB00008071 ( Other Identifier: OHSU Knight Cancer Institute ) P30CA069533 ( U.S. NIH Grant/Contract ) |
| First Posted: | December 13, 2012 Key Record Dates |
| Results First Posted: | September 12, 2017 |
| Last Update Posted: | June 19, 2018 |
| Last Verified: | June 2018 |
Additional relevant MeSH terms:
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Carcinoma Carcinoma, Squamous Cell Squamous Cell Carcinoma of Head and Neck Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell Head and Neck Neoplasms Neoplasms by Site Dexamethasone Dexamethasone acetate Ichthammol 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 Dermatologic Agents |