Functional Outcome After Treatment for Oropharyngeal Squamous Cell Carcinoma

Rigshospitalet, Denmark44 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

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

Interventions

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).

Radio(chemo)therapyRADIATION

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Rigshospitalet

Copenhagen, Denmark

Outcomes

Primary Outcomes

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