Functional Outcome After Treatment for Oropharyngeal Squamous Cell Carcinoma

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Functional Outcome After Transoral Robotic Surgery (TORS) vs Oncological Treatment for Oropharyngeal Squamous Cell Carcinoma

Conditions
-----------------
Oropharynx Cancer, Pain, Swallowing Disorder, Quality of Life, Saliva Altered, Human Papilloma Virus

Intervention / Treatment
-----------------
* Procedure: Primary Trans Oral Robotic Surgery (TORS)
* Radiation: Radio(chemo)therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: TORS group: WHO performance status 0-2 Squamous cell carcinoma of the oropharynx TNM: T1-2, N0-1 (without of evidence of extra capsular extent), M0. No previous head and neck cancer Absence of factors that inhibit the patient from participate in all or parts of the study e.g. geographical, mental, cognitive or other. Signed written consent. Cancer eligible for surgery in the absence of significant trismus. Oncological group: WHO performance status 0-2 Squamous cell carcinoma of the oropharynx Qualified for curative intended oncological treatment Signed written consent Exclusion Criteria: TORS group: Serious co-morbidity Distant metastasis Previous radiotherapy to the head and neck region. Concurrent treatment eller investigations for another cancer, except carcinoma in situ. Oncological group: Previous radiotherapy to the head and neck region. Concurrent treatment eller investigations for another cancer, except carcinoma in situ. Presence of factors that inhibit the patient from participate in all or parts of the study e.g. geographical, mental, cognitive or other. Presence of facors that inhibit the patient from completing the treatment. Previous head and neck cancer Distant metastasis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Oropharyngeal carcinoma (excluding M+ stage)<br>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). | Procedure: Primary Trans Oral Robotic Surgery (TORS)<br>* 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).<br>Radiation: Radio(chemo)therapy<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 |