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| ID | Type | Description | Link |
|---|---|---|---|
| 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 | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (treatment) | Experimental | 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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| Arm II (control) | Active Comparator | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | Given IV |
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| Measure | Description | Time Frame |
|---|---|---|
| Pain Visual Analogue Scale (VAS) Score Measured at 10-point Scale | 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. | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Complications Associated With Postoperative Corticosteroid Use After TORS | A descriptive statistical analysis will be conducted on complications. | Up to 30 days |
| Eating Assessment Tool (EAT)-10 Scores |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Clayburgh | OHSU Knight Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OHSU Knight Cancer Institute | Portland | Oregon | 97239 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28850681 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm I (Treatment) | Patients receive dexamethasone IV at the time of surgery and PO every 8 hours for up to 4 days following surgery. Dexamethasone: Given IV Dexamethasone: Given PO Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Transoral Robotic Surgery: Undergo TORS |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Dexamethasone | Drug | Given PO |
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| Placebo | Other | Given PO |
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| Quality-of-Life Assessment | Procedure | Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
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| Transoral Robotic Surgery | Procedure | Undergo TORS |
|
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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.
| Up to 12 months |
| Length of Hospital Stay (Number of Days Between the Date of Surgery and Date of Discharge) | Kaplan-Meier functions will be fitted to compare the length of hospital stay between the experimental and control groups. | Up to 21 days |
| PSS Normalcy of Diet | 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)" | 30 days |
| Opioid Use | 3 days |
| UM-QOL Eating | 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. | 21 days |
| Days With Feeding Tube | 12 months |
| 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. Dexamethasone: Given IV Placebo: Given PO Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Transoral Robotic Surgery: Undergo TORS |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm I (Treatment) | Patients receive dexamethasone IV at the time of surgery and PO every 8 hours for up to 4 days following surgery. Dexamethasone: Given IV Dexamethasone: Given PO Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Transoral Robotic Surgery: Undergo TORS |
| BG001 | 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. Dexamethasone: Given IV Placebo: Given PO Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Transoral Robotic Surgery: Undergo TORS |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| VAS pain score | 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". | Mean | Standard Deviation | units on a scale |
| ||||||||||||||||
| Tumor stage | Tumor stage is assessed using American Joint Committee on Cancer (AJCC) TNM staging of oropharyngeal squamous cell carcinoma: T1 = Tumor 2 cm or less in greatest dimension. T2 = Tumor more than 2 cm but not more than 4 cm in greatest dimension. T3 = Tumor more than 4 cm in greatest dimension or extension to lingual surface of epiglottis. T4a = Moderately advanced local disease. T4b = Very advance local disease. | Count of Participants | Participants |
| |||||||||||||||||
| EAT-10 score | Mean overall score of the EAT-10 tool. 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". | Mean | Standard Deviation | units on a scale |
| ||||||||||||||||
| PSS normalcy of diet | 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)" | Mean | Standard Deviation | units on a scale |
| ||||||||||||||||
| UM-QOL eating score | 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". | Mean | Standard Deviation | units on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain Visual Analogue Scale (VAS) Score Measured at 10-point Scale | 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. | Posted | Mean | Standard Deviation | units on a scale | 21 days |
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| Secondary | Complications Associated With Postoperative Corticosteroid Use After TORS | A descriptive statistical analysis will be conducted on complications. | Posted | Count of Participants | Participants | Up to 30 days |
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| Secondary | Eating Assessment Tool (EAT)-10 Scores | 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. | Posted | Mean | Standard Deviation | units on a scale | Up to 12 months |
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| Secondary | Length of Hospital Stay (Number of Days Between the Date of Surgery and Date of Discharge) | Kaplan-Meier functions will be fitted to compare the length of hospital stay between the experimental and control groups. | Posted | Median | Standard Deviation | days | Up to 21 days |
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| Secondary | PSS Normalcy of Diet | 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)" | Posted | Mean | Standard Deviation | units on a scale | 30 days |
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| Secondary | Opioid Use | Posted | Mean | Standard Deviation | mg of oxycodone equivalent | 3 days |
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| Secondary | UM-QOL Eating | 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. | Posted | Mean | Standard Deviation | units on a scale | 21 days |
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| Secondary | Days With Feeding Tube | Posted | Median | Full Range | days | 12 months |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm I (Treatment) | Patients receive dexamethasone IV at the time of surgery and PO every 8 hours for up to 4 days following surgery. Dexamethasone: Given IV Dexamethasone: Given PO Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Transoral Robotic Surgery: Undergo TORS | 10 | 35 | 0 | 35 | ||
| EG001 | 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. Dexamethasone: Given IV Placebo: Given PO Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Transoral Robotic Surgery: Undergo TORS | 7 | 33 | 0 | 33 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| oropharyngeal hemorrhage | Surgical and medical procedures | Systematic Assessment |
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| Neck hematoma | Surgical and medical procedures |
| |||
| Pneumonia | Respiratory, thoracic and mediastinal disorders |
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| Chyle leak | Surgical and medical procedures |
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| Readmission/failure to thrive | Surgical and medical procedures |
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| abscess | Surgical and medical procedures |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel Clayburgh, MD PhD | Oregon Health and Science University | 503-494-8510 | clayburg@ohsu.edu |
| ID | Term |
|---|---|
| D003680 | Deglutition Disorders |
| D010146 | Pain |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D002123 | Calcium Dobesilate |
| C059464 | auricularum |
| C018038 | dexamethasone acetate |
| C004180 | dexamethasone 21-phosphate |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
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| >=65 years |
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| Male |
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| T2 |
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| Postoperative day #3 |
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| Postoperative day #7-21 |
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| Units | Counts |
|---|---|
| Participants |
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