AnalgesiaPhase 3NCT04189107
Postoperative Pain, Why Still in Hospital and DAOH Following TORS for SCCUP & OSAS
A Phase 3 study testing Dexamethasone in people with Analgesia and Surgery, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Analgesia, Surgery, Cancer of Head and Neck
- What is being tested?
- Dexamethasone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteDenmark
- Study dates
- 18 Aug 2020to 9 Nov 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- 18 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.
Who cannot join
- 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
Show all 11Show fewer
- Allergy to glucocorticoids
- Preoperative daily use of systemic glucocorticoids <90 days before the surgery Glucocorticoids administered to the patient's routine examination under general anesthesia with bilateral biopsies from base of the tongue, adenoidectomy and concurrent tonsillectomy are not a part of this exclusion criteria. Only systemic daily use <90 prior TORS is an exclusion criterion.
- Preoperative use of biological anti-inflammatory medication <90 days before the surgery
- Active gastric ulcer in the opinion of the investigator
- Pregnancy/Breastfeeding
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Otorhinolaryngology, Head and Neck Surgery & Audiology
Copenhagen, 2100
About this study
Official title: An Investigation of Postoperative Pain, Why Still in Hospital and Days Alive and Out of Hospital Following Transoral Robotic Surgery for Squamous Cell Carcinoma of Unknown Primary and Obstructive Sleep Apnea
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.
- 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.
- 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
- 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.
Read the detailed description
The morbidity after TORS has not yet been fully investigated, but a recent studies suggest that pain is one of the primary causes for unplanned readmission This issue has been investigated by Clayburgh D et al who found that a prolonged dexamethasone regime lowered the pain scores on day three after surgery. The patients treated with the prolonged dexamethasone regime also showed a significant improvement in the food consistency they were capable to swallow and had a shortened length of stay (LOS). Recently, a pilot-study showed, that an intensified dexamethasone regime among TORS patients reduced the pain level to that of a standard tonsillectomy. Besides an analgesic effect glucocorticoids furthermore poses an anti-inflammatory quality which can be used to lower the physiological stress and inflammatory response following surgery and may prevent organ dysfunctions and complications The analgesic effect of dexamethasone has been the topic of many clinical studies, and are well described in various surgical fields. However, the optimal dose and regime for glucocorticoids prescription has so far not been established. The evidence favoring one dosage regime and an optimal prescribed dose is restricted by the variance in the regimes used in various clinical trials and the fact that there is a need for clinical trial investigating steroids with pain as the primary endpoint Consequently, it is important to thoroughly investigate and optimize the analgesic regime after TORS.
Hospitalization So far when evaluating the long-term consequences of TORS, the main focus has been on oncological outcomes and quality of life with attention to functional outcomes, i.e. feeding tube dependency and dysphagia while the LOS following TORS and why the patient is hospitalized after the procedure have been sparsely studied.
The reason why TORS patients are still hospitalized after the procedure and which clinical and organizational factors contribute to the hospitalization have not yet been examined and understood but is highly relevant in order to understand and improve the postoperative care.
A method to assess the efficiency of a therapy have emerged from the cardiology field and is called Days Alive and Out of Hospital (DAOH). This has been used in investigations of heart failure patients and myocardial infarction patients. This outcome combines mortality and morbidity, and accounts for the number but also duration of several hospitalizations after the primary discharge.
DAOH has only sparse been used in the surgical field, and only in few studies in the cardiac surgery area. The measurement is a patient-centered outcome that provide better information to the patient and surgeon when planning surgery, and can be used for quality improvement studies since it accounts for effective and efficient care.
Therefore, the DAOH measurement applied to the evaluation of TORS treatment for SCCUP will benefit the insight in how the patient's life after treatment is affected.
The aims of this study comprising patients treated with TORS for SCCUP:
- To lower the patients pain intensity after the TORS procedure with an intensified dexamethasone regimen.
- To investigate the clinical and organizational factors contributing to hospitalization after TORS, and with this knowledge to establish an optimized postoperative care program.
- To measure the efficiency and morbidity after TORS using DAOH as a descriptive assessment 12 months postoperatively.
This project consists of four studies:
Study 1 - Corresponding to aim A. The investigators hypothesize that an intensified dexamethasone regime will lower patients' reported pain intensity following TORS. This will be investigated in a randomized (1:1) double-blinded clinical trial among SCCUP patients undergoing TORS and extrapolated to the entire TORS population.
- A routine surgical complications study will be performed and examine surgical complications within the first 30 postoperative days.
Study 2 - Corresponding to aim B The investigators hypothesize that not much is known about the precise reasons for why patients are hospitalized following TORS. Hence, a prospective observational study regarding "why still in hospital after TORS?" will be conducted among all patients with SCCUP scheduled for TORS.
Study 3 - Corresponding to aim C The investigators hypothesize that TORS is an efficient procedure with a low morbidity. Hence, a prospective observational study regarding DAOH will be conducted among all SCCUP patients scheduled for TORS.
- Conditions
- Analgesia, Surgery, Cancer of Head and Neck, Oropharyngeal Cancer, Carcinoma of Unknown Primary, Pain, Postoperative
- Being tested
- Dexamethasone, Placebo
- Medical subject headings
- Agnosia, Head and Neck Neoplasms, Oropharyngeal Neoplasms, Neoplasms, Unknown Primary, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called High-dose
High-dose dexamethasone peroperative and postoperative on day 2 and 4
PlaceboDrug
Also called Low-dose dexamethasone
low dose dexamethasone peroperative and placebo postoperatively on day 2 and 4
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | High dose Dexamethasone Receives: Drug: Dexamethasone |
| Control | Placebo comparator | Standard dexamethasone dosage and placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Postoperative day 1 until day 14 postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2019
- Study start18 Aug 2020
- Primary completion9 Nov 2022
- Study completion9 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 Randomization to either experimental or control treatment
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Candys Foundation, Region Capital Denmark, Odense University Hospital, Aarhus University Hospital
- Responsible party
- Principal investigator, Mikkel Hjordt Holm Larsen, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04189107
- Sponsor's protocol ID
- DexaCup
- Status last verified
- Mar 2023
- First submitted
- 4 Dec 2019
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of Postoperative Pain, Why Still in Hospital and Days Alive and Out of Hospital Following Transoral Robotic Surgery for Squamous Cell Carcinoma of Unknown Primary and Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT04189107
- Acronym / sponsor ID
- DexaCup
- Conditions
- Analgesia, Surgery, Cancer of Head and Neck, Oropharyngeal Cancer, Carcinoma of Unknown Primary, Pain, Postoperative
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Candys Foundation, Region Capital Denmark, Odense University Hospital, Aarhus University Hospital
- Study start
- 18 Aug 2020 (actual)
- Primary completion
- 9 Nov 2022 (actual)
- Study completion
- 9 Nov 2022 (actual)
- First posted
- 6 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- 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
- 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.
Detailed description
The morbidity after TORS has not yet been fully investigated, but a recent studies suggest that pain is one of the primary causes for unplanned readmission This issue has been investigated by Clayburgh D et al who found that a prolonged dexamethasone regime lowered the pain scores on day three after surgery. The patients treated with the prolonged dexamethasone regime also showed a significant improvement in the food consistency they were capable to swallow and had a shortened length of stay (LOS). Recently, a pilot-study showed, that an intensified dexamethasone regime among TORS patients reduced the pain level to that of a standard tonsillectomy. Besides an analgesic effect glucocorticoids furthermore poses an anti-inflammatory quality which can be used to lower the physiological stress and inflammatory response following surgery and may prevent organ dysfunctions and complications The analgesic effect of dexamethasone has been the topic of many clinical studies, and are well described in various surgical fields. However, the optimal dose and regime for glucocorticoids prescription has so far not been established. The evidence favoring one dosage regime and an optimal prescribed dose is restricted by the variance in the regimes used in various clinical trials and the fact that there is a need for clinical trial investigating steroids with pain as the primary endpoint Consequently, it is important to thoroughly investigate and optimize the analgesic regime after TORS.
Hospitalization So far when evaluating the long-term consequences of TORS, the main focus has been on oncological outcomes and quality of life with attention to functional outcomes, i.e. feeding tube dependency and dysphagia while the LOS following TORS and why the patient is hospitalized after the procedure have been sparsely studied.
The reason why TORS patients are still hospitalized after the procedure and which clinical and organizational factors contribute to the hospitalization have not yet been examined and understood but is highly relevant in order to understand and improve the postoperative care.
A method to assess the efficiency of a therapy have emerged from the cardiology field and is called Days Alive and Out of Hospital (DAOH). This has been used in investigations of heart failure patients and myocardial infarction patients. This outcome combines mortality and morbidity, and accounts for the number but also duration of several hospitalizations after the primary discharge.
DAOH has only sparse been used in the surgical field, and only in few studies in the cardiac surgery area. The measurement is a patient-centered outcome that provide better information to the patient and surgeon when planning surgery, and can be used for quality improvement studies since it accounts for effective and efficient care.
Therefore, the DAOH measurement applied to the evaluation of TORS treatment for SCCUP will benefit the insight in how the patient's life after treatment is affected.
The aims of this study comprising patients treated with TORS for SCCUP:
- To lower the patients pain intensity after the TORS procedure with an intensified dexamethasone regimen.
- To investigate the clinical and organizational factors contributing to hospitalization after TORS, and with this knowledge to establish an optimized postoperative care program.
- To measure the efficiency and morbidity after TORS using DAOH as a descriptive assessment 12 months postoperatively.
This project consists of four studies:
Study 1 - Corresponding to aim A. The investigators hypothesize that an intensified dexamethasone regime will lower patients' reported pain intensity following TORS. This will be investigated in a randomized (1:1) double-blinded clinical trial among SCCUP patients undergoing TORS and extrapolated to the entire TORS population.
- A routine surgical complications study will be performed and examine surgical complications within the first 30 postoperative days.
Study 2 - Corresponding to aim B The investigators hypothesize that not much is known about the precise reasons for why patients are hospitalized following TORS. Hence, a prospective observational study regarding "why still in hospital after TORS?" will be conducted among all patients with SCCUP scheduled for TORS.
Study 3 - Corresponding to aim C The investigators hypothesize that TORS is an efficient procedure with a low morbidity. Hence, a prospective observational study regarding DAOH will be conducted among all SCCUP patients scheduled for TORS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 1:1 Randomization to either experimental or control treatment
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: DexamethasoneHigh dose Dexamethasone |
| Control | Placebo comparator | Drug: PlaceboStandard dexamethasone dosage and placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 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
Key exclusion criteria (11 listed)
- 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
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: High-doseHigh-dose dexamethasone peroperative and postoperative on day 2 and 4 | Drug | Experimental |
| PlaceboAlso: Low-dose dexamethasonelow dose dexamethasone peroperative and placebo postoperatively on day 2 and 4 | Drug | Control |
Primary outcome
Patient-reported Pain intensity
Time frame: Postoperative day 1 until day 14 postoperatively
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexamethasone in people with Analgesia and Surgery, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 6 inclusion and 11 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 16 Mar 2023. 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 Denmark. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Patient-reported Pain intensity (time frame: Postoperative day 1 until day 14 postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Mar 2023.