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

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ClinicalTrials.gov Identifier: NCT01748942
Recruitment Status : Completed
First Posted : December 13, 2012
Results First Posted : September 12, 2017
Last Update Posted : June 19, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Daniel Clayburgh, OHSU Knight Cancer Institute

Tracking Information
First Submitted Date  ICMJE December 11, 2012
First Posted Date  ICMJE December 13, 2012
Results First Submitted Date  ICMJE May 8, 2017
Results First Posted Date  ICMJE September 12, 2017
Last Update Posted Date June 19, 2018
Study Start Date  ICMJE December 2012
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 10, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 12, 2012)
Pain Visual Analogue Scale (VAS) Score Measured at 10-point Scale [ Time Frame: Up to 21 days ]
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2017)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 12, 2012)
  • Eating Assessment Tool (EAT)-10 scores [ Time Frame: Up to 21 days ]
    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.
  • Narcotic pain medication usage [ Time Frame: Up to 21 days ]
    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 ]
    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 ]
    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 ]
    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 ]
    Descriptive statistical analyses will be conducted for a summary of VAS scores at baseline, days 1, 2, 3 and day 7-21 after surgery
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dexamethasone in Reducing Oral Pain and Dry Mouth After Surgery in Patients With Oropharyngeal Cancer
Official Title  ICMJE A Randomized, Placebo Controlled, Double Blinded Study of Corticosteroid Treatment for the Reduction of Postoperative Pain Following Transoral Robotic Surgery
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Dysphagia
  • Pain
  • Stage I Oropharyngeal Squamous Cell Carcinoma
  • Stage II Oropharyngeal Squamous Cell Carcinoma
  • Stage III Oropharyngeal Squamous Cell Carcinoma
Intervention  ICMJE
  • Drug: Dexamethasone
    Given IV
    Other Names:
    • Aacidexam
    • Adexone
    • Aknichthol Dexa
    • Alba-Dex
    • Alin
    • Alin Depot
    • Alin Oftalmico
    • Amplidermis
    • Anemul mono
    • Auricularum
    • Auxiloson
    • Baycuten
    • Baycuten N
    • Cortidexason
    • Cortisumman
    • Decacort
    • Decadrol
    • Decadron
    • Decalix
    • Decameth
    • Decasone R.p.
    • Dectancyl
    • Dekacort
    • Deltafluorene
    • Deronil
    • Desamethasone
    • Desameton
    • Dexa-Mamallet
    • Dexa-Rhinosan
    • Dexa-Scheroson
    • Dexa-sine
    • Dexacortal
    • Dexacortin
    • Dexafarma
    • Dexafluorene
    • Dexalocal
    • Dexamecortin
    • Dexameth
    • Dexamethasonum
    • Dexamonozon
    • Dexapos
    • Dexinoral
    • Dexone
    • Dinormon
    • Fluorodelta
    • Fortecortin
    • Gammacorten
    • Hexadecadrol
    • Hexadrol
    • Lokalison-F
    • Loverine
    • Methylfluorprednisolone
    • Millicorten
    • Mymethasone
    • Orgadrone
    • Spersadex
    • Visumetazone
  • Drug: Dexamethasone
    Given PO
    Other Names:
    • Aacidexam
    • Adexone
    • Aknichthol Dexa
    • Alba-Dex
    • Alin
    • Alin Depot
    • Alin Oftalmico
    • Amplidermis
    • Anemul mono
    • Auricularum
    • Auxiloson
    • Baycuten
    • Baycuten N
    • Cortidexason
    • Cortisumman
    • Decacort
    • Decadrol
    • Decadron
    • Decalix
    • Decameth
    • Decasone R.p.
    • Dectancyl
    • Dekacort
    • Deltafluorene
    • Deronil
    • Desamethasone
    • Desameton
    • Dexa-Mamallet
    • Dexa-Rhinosan
    • Dexa-Scheroson
    • Dexa-sine
    • Dexacortal
    • Dexacortin
    • Dexafarma
    • Dexafluorene
    • Dexalocal
    • Dexamecortin
    • Dexameth
    • Dexamethasonum
    • Dexamonozon
    • Dexapos
    • Dexinoral
    • Dexone
    • Dinormon
    • Fluorodelta
    • Fortecortin
    • Gammacorten
    • Hexadecadrol
    • Hexadrol
    • Lokalison-F
    • Loverine
    • Methylfluorprednisolone
    • Millicorten
    • Mymethasone
    • Orgadrone
    • Spersadex
    • Visumetazone
  • Other: Placebo
    Given PO
    Other Names:
    • placebo therapy
    • PLCB
    • sham therapy
  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Dexamethasone
    • Drug: Dexamethasone
    • Procedure: Quality-of-Life Assessment
    • Other: Questionnaire Administration
    • Procedure: Transoral Robotic Surgery
  • 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.
    Interventions:
    • Drug: Dexamethasone
    • Other: Placebo
    • Procedure: Quality-of-Life Assessment
    • Other: Questionnaire Administration
    • Procedure: Transoral Robotic Surgery
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 10, 2017)
76
Original Estimated Enrollment  ICMJE
 (submitted: December 12, 2012)
72
Actual Study Completion Date  ICMJE March 29, 2017
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01748942
Other Study ID Numbers  ICMJE 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 )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Daniel Clayburgh, OHSU Knight Cancer Institute
Study Sponsor  ICMJE OHSU Knight Cancer Institute
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Daniel Clayburgh OHSU Knight Cancer Institute
PRS Account OHSU Knight Cancer Institute
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP