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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2017-03-29

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Dysphagia Pain Stage I Oropharyngeal Squamous Cell Carcinoma Stage II Oropharyngeal Squamous Cell Carcinoma Stage III Oropharyngeal Squamous Cell Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm I (treatment)

Patients receive dexamethasone IV at the time of surgery and PO every 8 hours for up to 4 days following surgery.

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type DRUG

Given IV

Dexamethasone

Intervention Type DRUG

Given PO

Quality-of-Life Assessment

Intervention Type PROCEDURE

Ancillary studies

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Transoral Robotic Surgery

Intervention Type PROCEDURE

Undergo TORS

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.

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

Given IV

Placebo

Intervention Type OTHER

Given PO

Quality-of-Life Assessment

Intervention Type PROCEDURE

Ancillary studies

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Transoral Robotic Surgery

Intervention Type PROCEDURE

Undergo TORS

Interventions

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Dexamethasone

Given IV

Intervention Type DRUG

Dexamethasone

Given PO

Intervention Type DRUG

Placebo

Given PO

Intervention Type OTHER

Quality-of-Life Assessment

Ancillary studies

Intervention Type PROCEDURE

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Transoral Robotic Surgery

Undergo TORS

Intervention Type PROCEDURE

Other Intervention Names

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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 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 placebo therapy PLCB sham therapy Quality of Life Assessment TORS

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No