Functional Outcome After Treatment for Oropharyngeal Squamous Cell Carcinoma

Active, not recruiting

• Conditions: Swallowing Disorder; Quality of Life; Saliva Altered; Human Papilloma Virus; Oropharynx Cancer; Pain
• Interventions: Procedure: Primary Trans Oral Robotic Surgery (TORS); Radiation: Radio(chemo)therapy

• Registration Number: NCT03418909
• Lead Sponsor: Rigshospitalet, Denmark

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.

Study Timeline

• Study Start: 2017-04-01
• Study First Submitted: 2018-01-19
• Study First Submitted QC: 2018-01-25
• Study First Posted: 2018-02-01
• Primary Completion: 2021-12-31
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-29
• Last Update Posted: 2023-03-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Oropharyngeal carcinoma (excluding M+ stage)	Primary Trans Oral Robotic Surgery (TORS)	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).
Oropharyngeal carcinoma (excluding M+ stage)	Radio(chemo)therapy	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).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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 (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.
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).

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark