Functional Outcome After Treatment for Oropharyngeal Squamous Cell Carcinoma

NCT03418909 | Unknown DMC

• 2 other identifiers: H-1-2014-033H-17015164
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Changes in swallowing function (MBSS)

  3 and 12 months as well as 3 years after treatment

• Changes in swallowing function (FEES)

  3 and 12 months as well as 3 years after treatment

• Change to quality of life scores (MDADI)

  3 and 12 months as well as 3 years after treatment

• Change to quality of life scores (EORTC QLQ-C30)

  3 and 12 months as well as 3 years after treatment

• Change to quality of life scores (EORTC QLQ-H&N35)

  3 and 12 months as well as 3 years after treatment

Study Arms (1)

Oropharyngeal carcinoma (excluding M+ stage)

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

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).

Oropharyngeal carcinoma (excluding M+ stage)

Radio(chemo)therapy RADIATION

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.

Oropharyngeal carcinoma (excluding M+ stage)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Eligible patients with histologically verified oropharyngeal squamous cell carcinoma treated either with TORS or primary radiotherapy (with or without chemotherapy) with curative intent.

You may qualify if:

• TORS group:
• WHO performance status 0-2
• Squamous cell carcinoma of the oropharynx
• TNM: T1-2, N0-1 (without of evidence of extra capsular extent), M0.
• No previous head and neck cancer
• Absence of factors that inhibit the patient from participate in all or parts of the study e.g. geographical, mental, cognitive or other.
• Signed written consent.
• Cancer eligible for surgery in the absence of significant trismus.
• Oncological group:
• WHO performance status 0-2
• Squamous cell carcinoma of the oropharynx
• Qualified for curative intended oncological treatment
• Signed written consent

You may not qualify if:

• TORS group:
• Serious co-morbidity
• Distant metastasis
• Previous radiotherapy to the head and neck region.
• Concurrent treatment eller investigations for another cancer, except carcinoma in situ.
• Oncological group:
• Previous radiotherapy to the head and neck region.
• Concurrent treatment eller investigations for another cancer, except carcinoma in situ.
• Presence of factors that inhibit the patient from participate in all or parts of the study e.g. geographical, mental, cognitive or other.
• Presence of facors that inhibit the patient from completing the treatment.
• Previous head and neck cancer
• Distant metastasis

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (1)

• Scott SI, Madsen AKO, Rubek N, Charabi BW, Wessel I, Jensen CV, Friborg J, von Buchwald C. Dysphagia and QoL 3 Years After Treatment of Oropharyngeal Cancer With TORS or Radiotherapy. Laryngoscope. 2023 Aug;133(8):1893-1898. doi: 10.1002/lary.30410. Epub 2022 Oct 14.

  PMID: 36239625 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Saliva samples for later analysis of composition and changes in composition following treatment.

MeSH Terms

Conditions

Oropharyngeal Neoplasms; Pain; Deglutition Disorders

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Christian von Buchwald, MD, dr. med.

  Rigshospitalet, Denmark

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD student

Study Record Dates

• First Submitted: January 19, 2018
• First Posted: February 1, 2018
• Study Start: April 1, 2017
• Primary Completion: December 31, 2021
• Study Completion: June 30, 2024
• Last Updated: March 30, 2023

Record last verified: 2023-03

Locations

DK (1)