Postoperative Pain, Why Still in Hospital and DAOH Following TORS for SCCUP & OSAS

NCT04189107 | Completed Phase 3 DMC

• 1 other identifier: DexaCup
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This protocol investigates the effect of a high dose dexamethasone regimen in the treatment of postoperative pain following Transoral Robotic Surgery (TORS). The protocol consists of three substudies.

1. 1.Randomized double-blinded clinical trial assigning half of the participants to a high-dose dexamethasone regimen while the other half will receive a low-dose dexamethasone dosage and placebo in the first postoperative period.
2. 2.A investigation of "Why in hospital?" following TORS. From the first postoperative day until discharge reasons for continued hospitalization will be registered in order to identify clinical and organizational factors contributing to hospitalization
3. 3.An assessment of "Days Alive and Out of Hospital" following TORS. From the day of surgery and the first 12 postoperative months all admissions to a hospital ward will be registered along with admission reasons. Any death during the first 12 months will be noted with a cause of death.

Conditions

Analgesia; Surgery; Cancer of Head and Neck; Oropharyngeal Cancer; Carcinoma of Unknown Primary; Pain, Postoperative; Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Patient-reported Pain intensity

  Visual analog scale (VAS) ranging from 0-10. 0 being no pain and 10 being maximum pain. The patient will twice daily self-assess pain-intensity during both rest and activity (swallowing). The pain-intensity will be noted in a pain-diary

  Postoperative day 1 until day 14 postoperatively

Other Outcomes (2)

• Why in hospital

  Postoperative day 1 until discharge

• Days Alive and Out of Hospital

  From the day of surgery and the first 12 postoperative months

Study Arms (2)

Experimental

EXPERIMENTAL

High dose Dexamethasone

Drug: Dexamethasone

Control

PLACEBO COMPARATOR

Standard dexamethasone dosage and placebo

Drug: Placebo

Interventions

Dexamethasone DRUG

High-dose dexamethasone peroperative and postoperative on day 2 and 4

Also known as: High-dose

Experimental

Placebo DRUG

low dose dexamethasone peroperative and placebo postoperatively on day 2 and 4

Also known as: Low-dose dexamethasone

Control

Eligibility Criteria

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

You may qualify if:

• years or older
• Ability to provide a written informed consent
• ECOG/WHO performance status 0-2
• Squamous cell carcinoma of unknown primary or obstructive sleep apnea
• Booked for TORS based on radiologic and clinical assessment by an ENT surgeon oTORS for obstructive sleep apnea must be preceded by a Drug-induced sleep endoscopy (DISE) examination
• Negative Urine HCG pregnancy test for women in the fertile age.

You may not qualify if:

• Serious medical comorbidities (ECOG/WHO performance status \>2). Other contraindications to surgery
• Distant metastasis
• Active Herpes zoster
• Previous head and neck cancer
• Significant trismus, maximum inter-incisal opening 35mm
• Insulin dependent diabetes
• Allergy to glucocorticoids
• Preoperative use of biological anti-inflammatory medication \<90 days before the surgery
• Active gastric ulcer in the opinion of the investigator
• Pregnancy/Breastfeeding

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Candys Foundation: collaborator
• Region Capital Denmark: collaborator
• Odense University Hospital: collaborator
• Aarhus University Hospital: collaborator

Study Sites (1)

Department of Otorhinolaryngology, Head and Neck Surgery & Audiology

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Agnosia; Head and Neck Neoplasms; Oropharyngeal Neoplasms; Neoplasms, Unknown Primary; Pain, Postoperative

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Postoperative Complications; Pain

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinating investigator, MD

Model Details: 1:1 Randomization to either experimental or control treatment

Study Record Dates

• First Submitted: December 4, 2019
• First Posted: December 6, 2019
• Study Start: August 18, 2020
• Primary Completion: November 9, 2022
• Study Completion: November 9, 2022
• Last Updated: March 16, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)