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

NCT01748942 | Completed Results DMC

• 5 other identifiers: IRB00008071NCI-2012-02780CPC-12095-LCR00021919P30CA069533
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Complications Associated With Postoperative Corticosteroid Use After TORS

  Up to 30 days

• Eating Assessment Tool (EAT)-10 Scores

  Up to 12 months

• Length of Hospital Stay (Number of Days Between the Date of Surgery and Date of Discharge)

  Up to 21 days

• PSS Normalcy of Diet

  30 days

• Opioid Use

  3 days

Study Arms (2)

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.

Drug: Dexamethasone; Procedure: Quality-of-Life Assessment; Other: Questionnaire Administration; Procedure: Transoral Robotic Surgery

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.

Drug: Dexamethasone; Other: Placebo; Procedure: Quality-of-Life Assessment; Other: Questionnaire Administration; Procedure: Transoral Robotic Surgery

Interventions

Dexamethasone DRUG

Given IV

Also known as: 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

Arm I (treatment); Arm II (control)

Placebo OTHER

Given PO

Also known as: placebo therapy, PLCB, sham therapy

Arm II (control)

Quality-of-Life Assessment PROCEDURE

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (treatment); Arm II (control)

Questionnaire Administration OTHER

Ancillary studies

Arm I (treatment); Arm II (control)

Transoral Robotic Surgery PROCEDURE

Undergo TORS

Also known as: TORS

Arm I (treatment); Arm II (control)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location

Related Publications (1)

• 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.

  PMID: 28850681 DERIVED

MeSH Terms

Conditions

Deglutition Disorders; Pain; Squamous Cell Carcinoma of Head and Neck

Interventions

Dexamethasone; Calcium Dobesilate; auricularum; dexamethasone acetate; dexamethasone 21-phosphate

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Results Point of Contact

• Title: Daniel Clayburgh, MD PhD
• Organization: Oregon Health and Science University

clayburg@ohsu.edu

503-494-8510

Study Officials

• Daniel Clayburgh

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 11, 2012
• First Posted: December 13, 2012
• Study Start: December 1, 2012
• Primary Completion: July 1, 2016
• Study Completion: March 29, 2017
• Last Updated: June 19, 2018
• Results First Posted: September 12, 2017

Record last verified: 2018-06

Locations

US (1)