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| ID | Type | Description | Link |
|---|---|---|---|
| H-17015164 | Other Identifier | Regional ethical committee |
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To investigate the treatment related effects of transoral robotic surgery (TORS) or oncological treatment of oropharyngeal squamous cell carcinoma with a 1-year follow up.
Patients are enrolled prospectively at the department of Otorhinolaryngology, Head and Neck Surgery & Audiology at Copenhagen University Hospital, Rigshospitalet.
All eligible patients with histologically verified squamous cell carcinoma of the oropharynx regardless of treatment option (as long as the intent is curative) can be included.
Outcome measures are assessed at baseline and repeated 3 and 12 months after treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oropharyngeal carcinoma (excluding M+ stage) | Eligible patients with histologically verified early stage squamous cell carcinoma of the oropharynx. Patients will be treated in accordance with current hospital protocols with transoral robotic surgery (T1-2, N1, M0) or radio(chemo)therapy (any T-stage, any N-stage, M0). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Primary Trans Oral Robotic Surgery (TORS) | Procedure | In the absence of severe mobidity patients with early stage disease (T1-2, N1, M0) were offered TORS, as an alternative to the standard of care (radiotherapy). |
| Measure | Description | Time Frame |
|---|---|---|
| Altered salivatory function | Measured as change in flow rate or composition compared to baseline measurements performed prior to treatment. | 3 and 12 months follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in swallowing function (MBSS) | Assessed using modified barium swallowing studies (MBSS). Evaluated as change from baseline. | 3 and 12 months as well as 3 years after treatment |
| Changes in swallowing function (FEES) |
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Inclusion Criteria:
TORS group:
Oncological group:
Exclusion Criteria:
TORS group:
Oncological group:
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Eligible patients with histologically verified oropharyngeal squamous cell carcinoma treated either with TORS or primary radiotherapy (with or without chemotherapy) with curative intent.
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| Name | Affiliation | Role |
|---|---|---|
| Christian von Buchwald, MD, dr. med. | Rigshospitalet, Denmark | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet | Copenhagen | 2100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36239625 | Derived | Scott SI, Madsen AKO, Rubek N, Charabi BW, Wessel I, Jensen CV, Friborg J, von Buchwald C. Dysphagia and QoL 3 Years After Treatment of Oropharyngeal Cancer With TORS or Radiotherapy. Laryngoscope. 2023 Aug;133(8):1893-1898. doi: 10.1002/lary.30410. Epub 2022 Oct 14. |
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| ID | Term |
|---|---|
| D009959 | Oropharyngeal Neoplasms |
| D010146 | Pain |
| D003680 | Deglutition Disorders |
| ID | Term |
|---|---|
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
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Saliva samples for later analysis of composition and changes in composition following treatment.
| Radio(chemo)therapy | Radiation | As the standard of care radiotherapy was offered to all of the patients. Patients that qualified for both TORS and radiotherapy were free to choose between the two. |
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Assessed using fiber endoscopic evaluation of swallowing function (FEES). Evaluated as change from baseline.
| 3 and 12 months as well as 3 years after treatment |
| Change to quality of life scores (MDADI) | Assessed using the MD Anderson Dysphagia Inventory (MDADI) questionnaire. Evaluated as change from baseline. | 3 and 12 months as well as 3 years after treatment |
| Change to quality of life scores (EORTC QLQ-C30) | Assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire. Evaluated as change from baseline. | 3 and 12 months as well as 3 years after treatment |
| Change to quality of life scores (EORTC QLQ-H&N35) | Assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-H&N35 questionnaire. Evaluated as change from baseline. | 3 and 12 months as well as 3 years after treatment |
| Treatment related pain | Assessed using a pain diary based on a 10 point visual analog scale (VAS). 0 being no pain and 10 the most severe pain. Registrered in increments of 1 (i.e. 3,5 is not an accepted score whereas 3 or 4 are). | For as long as the patient needs analgesics or up to three months |
| D009369 | Neoplasms |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |