Dexamethasone In Reducing Oral Pain And Dry Mouth After Surgery In Patients With Oropharyngeal Cance


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

Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Supportive Care

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 ]

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 21 days ] [ Designated as safety issue: No ]

A descriptive statistical analysis will be conducted on complications.

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.

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.

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 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

Procedure: Quality-of-Life Assessment

Other Name: Quality of Life Assessment

Other: Questionnaire Administration

Procedure: Transoral Robotic Surgery

Other Name: TORS

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.

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 Names:

placebo therapy

PLCB

sham therapy

Procedure: Quality-of-Life Assessment

Other Name: Quality of Life Assessment

Other: Questionnaire Administration

Procedure: Transoral Robotic Surgery

Other Name: TORS

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.

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.

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

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

United States, Oregon

OHSU Knight Cancer Institute

Portland, Oregon, United States, 97239

Sponsors and Collaborators

OHSU Knight Cancer Institute

National Cancer Institute (NCI)

OHSU Knight Cancer Institute

OHSU Knight Cancer Institute

Other Study ID Numbers:

IRB00008071 NCI-2012-02780 CPC-12095-L CR00021919 IRB00008071 P30CA069533

Study First Received:

December 11, 2012

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 September 19, 2016