DysphagiaNCT01748942
Dexamethasone in Reducing Oral Pain and Dry Mouth After Surgery in Patients With Oropharyngeal Cancer
A study testing Dexamethasone, Quality-of-Life Assessment and Questionnaire Administration in people with Dysphagia and Pain, run by OHSU Knight Cancer Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysphagia, Pain, Stage I Oropharyngeal Squamous Cell Carcinoma
- What is being tested?
- Dexamethasone, Quality-of-Life Assessment and Questionnaire Administration
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to 29 Mar 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
OHSU Knight Cancer Institute
Portland, Oregon, 97239
About this study
Official title: A Randomized, Placebo Controlled, Double Blinded Study of Corticosteroid Treatment for the Reduction of Postoperative Pain Following Transoral Robotic Surgery
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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
- Dysphagia, Pain, Stage I Oropharyngeal Squamous Cell Carcinoma, Stage II Oropharyngeal Squamous Cell Carcinoma, Stage III Oropharyngeal Squamous Cell Carcinoma
- Being tested
- Dexamethasone, Placebo, Quality-of-Life Assessment, Questionnaire Administration, Transoral Robotic Surgery
- Medical subject headings
- Deglutition Disorders, Pain, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called Aacidexam, Adexone, Aknichthol Dexa, Alba-Dex
Given IV
DexamethasoneDrug
Also called Aacidexam, Adexone, Aknichthol Dexa, Alba-Dex
Given PO
PlaceboOther
Also called placebo therapy, PLCB, sham therapy
Given PO
Quality-of-Life AssessmentProcedure or surgery
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
Transoral Robotic SurgeryProcedure or surgery
Also called TORS
Undergo TORS
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Dexamethasone; Other: Placebo; Procedure: Quality-of-Life Assessment; Other: Questionnaire Administration; Procedure: Transoral Robotic Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 21 days
Secondary outcomes (7)
Complications Associated With Postoperative Corticosteroid Use After TORS
A descriptive statistical analysis will be conducted on complications.
Measured: Up to 30 days
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.
Measured: 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.
Measured: 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)"
Measured: 30 days
Opioid Use
Measured: 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.
Measured: 21 days
Days With Feeding Tube
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionJul 2016
- Study completion29 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- More trials run by OHSU Knight Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Daniel Clayburgh, OHSU Knight Cancer Institute
- Investigators
- Daniel Clayburgh, Principal investigator, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01748942
- Sponsor's protocol ID
- IRB00008071
- Other IDs
- NCI-2012-02780, CPC-12095-L, CR00021919, IRB00008071, P30CA069533
- Status last verified
- Jun 2018
- First submitted
- 11 Dec 2012
- Last updated
- 19 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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.
PubMed 28850681
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo Controlled, Double Blinded Study of Corticosteroid Treatment for the Reduction of Postoperative Pain Following Transoral Robotic Surgery
- ClinicalTrials.gov ID
- NCT01748942
- Acronym / sponsor ID
- IRB00008071
- Conditions
- Dysphagia, Pain, Stage I Oropharyngeal Squamous Cell Carcinoma, Stage II Oropharyngeal Squamous Cell Carcinoma, Stage III Oropharyngeal Squamous Cell Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2012
- Primary completion
- Jul 2016 (actual)
- Study completion
- 29 Mar 2017 (actual)
- First posted
- 13 Dec 2012 (estimated)
- Results
- Posted 12 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (treatment) | Experimental | Drug: Dexamethasone, Procedure: Quality-of-Life Assessment, Other: Questionnaire Administration, Procedure: Transoral Robotic SurgeryPatients receive dexamethasone IV at the time of surgery and PO every 8 hours for up to 4 days following surgery. |
| Arm II (control) | Active comparator | Drug: Dexamethasone, Other: Placebo, Procedure: Quality-of-Life Assessment, Other: Questionnaire Administration, Procedure: Transoral Robotic SurgeryPatients receive dexamethasone IV at the time of surgery and placebo PO every 8 hours for up to 4 days following surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexamethasoneAlso: Aacidexam, Adexone, Aknichthol Dexa, Alba-DexGiven IV | Drug | Arm I (treatment), Arm II (control) |
| DexamethasoneAlso: Aacidexam, Adexone, Aknichthol Dexa, Alba-DexGiven PO | Drug | Arm I (treatment) |
| PlaceboAlso: placebo therapy, PLCB, sham therapyGiven PO | Other | Arm II (control) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Procedure or surgery | Arm I (treatment), Arm II (control) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (treatment), Arm II (control) |
| Transoral Robotic SurgeryAlso: TORSUndergo TORS | Procedure or surgery | Arm I (treatment), Arm II (control) |
Primary outcome
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.
7 secondary outcomes
Complications Associated With Postoperative Corticosteroid Use After TORS
Time frame: Up to 30 days
Eating Assessment Tool (EAT)-10 Scores
Time frame: Up to 12 months
Length of Hospital Stay (Number of Days Between the Date of Surgery and Date of Discharge)
Time frame: Up to 21 days
PSS Normalcy of Diet
Time frame: 30 days
Opioid Use
Time frame: 3 days
UM-QOL Eating
Time frame: 21 days
Days With Feeding Tube
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28850681Clayburgh 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Clayburgh principal investigator
OHSU Knight Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexamethasone, Quality-of-Life Assessment and Questionnaire Administration in people with Dysphagia and Pain, run by OHSU Knight Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Visual Analogue Scale (VAS) Score Measured at 10-point Scale (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01748942, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2018.