Functional Outcome After Treatment for Oropharyngeal Squamous Cell Carcinoma

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03418909
• Other study ID #: H-1-2014-033
• Secondary ID: H-17015164
• Status: Active, not recruiting
• Start date: April 1, 2017
• Est. completion date: June 30, 2024

Study information

• Verified date: March 2023
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 44
• Est. completion date: June 30, 2024
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Deglutition Disorders
• Human Papilloma Virus
• Oropharyngeal Neoplasms
• Oropharynx Cancer
• Pain
• Papilloma
• Quality of Life
• Saliva Altered
• Squamous Cell Carcinoma of Head and Neck
• Swallowing Disorder

Intervention

Procedure:
• Primary 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).

Radiation:
• Radio(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.

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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