An observational study in Oropharynx Cancer, Pain and Swallowing Disorder, sponsored by Rigshospitalet, Denmark. Status unknown at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-30.
Sponsored by Rigshospitalet, Denmark · Observational
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.
Eligible patients with histologically verified oropharyngeal squamous cell carcinoma treated either with TORS or primary radiotherapy (with or without chemotherapy) with curative intent.
TORS group:
Oncological group:
Exclusion Criteria:
TORS group:
Oncological group:
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) · Radiation: Radio(chemo)therapy
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).
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.
Altered salivatory function
Measured as change in flow rate or composition compared to baseline measurements performed prior to treatment.
Time frame: 3 and 12 months follow up
Changes in swallowing function (MBSS)
Assessed using modified barium swallowing studies (MBSS). Evaluated as change from baseline.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: For as long as the patient needs analgesics or up to three months
This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Rigshospitalet, Denmark