Human Papilloma Virus, Oropharynx Cancer, Pain, Quality of Life, Saliva Altered, Swallowing Disorder
Conditions
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.
Interventions
PROCEDUREPrimary Trans Oral Robotic Surgery (TORS)
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).
RADIATIONRadio(chemo)therapy
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.
Sponsors
Rigshospitalet, Denmark
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
TORS group: 1. WHO performance status 0-2 2. Squamous cell carcinoma of the oropharynx 3. TNM: T1-2, N0-1 (without of evidence of extra capsular extent), M0. 4. No previous head and neck cancer 5. Absence of factors that inhibit the patient from participate in all or parts of the study e.g. geographical, mental, cognitive or other. 6. Signed written consent. 7. Cancer eligible for surgery in the absence of significant trismus. Oncological group: 1. WHO performance status 0-2 2. Squamous cell carcinoma of the oropharynx 3. Qualified for curative intended oncological treatment 4. Signed written consent
Exclusion criteria
TORS group: 1. Serious co-morbidity 2. Distant metastasis 3. Previous radiotherapy to the head and neck region. 4. Concurrent treatment eller investigations for another cancer, except carcinoma in situ. Oncological group: 1. Previous radiotherapy to the head and neck region. 2. Concurrent treatment eller investigations for another cancer, except carcinoma in situ. 3. Presence of factors that inhibit the patient from participate in all or parts of the study e.g. geographical, mental, cognitive or other. 4. Presence of facors that inhibit the patient from completing the treatment. 5. Previous head and neck cancer 6. Distant metastasis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Altered salivatory function | 3 and 12 months follow up | Measured as change in flow rate or composition compared to baseline measurements performed prior to treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in swallowing function (FEES) | 3 and 12 months as well as 3 years after treatment | Assessed using fiber endoscopic evaluation of swallowing function (FEES). Evaluated as change from baseline. |
| Change to quality of life scores (MDADI) | 3 and 12 months as well as 3 years after treatment | Assessed using the MD Anderson Dysphagia Inventory (MDADI) questionnaire. Evaluated as change from baseline. |
| Changes in swallowing function (MBSS) | 3 and 12 months as well as 3 years after treatment | Assessed using modified barium swallowing studies (MBSS). Evaluated as change from baseline. |
| Change to quality of life scores (EORTC QLQ-H&N35) | 3 and 12 months as well as 3 years after treatment | Assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-H&N35 questionnaire. Evaluated as change from baseline. |
| Treatment related pain | For as long as the patient needs analgesics or up to three months | 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). |
| Change to quality of life scores (EORTC QLQ-C30) | 3 and 12 months as well as 3 years after treatment | Assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire. Evaluated as change from baseline. |
Countries
Denmark
Outcome results
None listed