Dysphagia and Quality of Life in Patients With Oral Squamous Cell Carcinoma Before and After Treatment

NCT06407570 | Not Yet Recruiting DMC

• 1 other identifier: CCOdysphagia
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

While the group of oral cavity cancer (OCC) survivors continue to increase, surgeons and oncologist intensify their search for improved treatment and rehabilitation methods to reduce the morbidity of management without compromising the oncological safety. The predominant problem after treatment of OCC is dysphagia, which is associated with malnutrition, aspiration pneumonia, hospital re-admission, and reduced quality of life (QoL) and survival. In a pilot study, the investigators found that 45% of OCC patients reported significant eating disabilities two years after surgical treatment. However, the international literature is limited on the dysphagia and QoL of OCC survivors. With an overall goal to improve the QoL and health status in patients treated for OCC, the present study aims to

1. 1.systematically evaluate the swallowing function before and after treatment,
2. 2.investigate the impact of swallowing function on QoL,
3. 3.identify risk factors for dysphagia,
4. 4.investigate if swallowing function is an independent factor for the number of ´days alive and out of hospital´
5. 5.evaluate the rehabilitation offered to OCC patients in Danish municipalities and the effect on swallowing outcomes.

Conditions

Oral Cavity Cancer; Dysphagia; Quality of Life

Keywords

Oral Cavity Cancer; Dysphagia; Quality of Life; Days alive and out of hospital; Rehabilitation

Outcome Measures

Primary Outcomes (3)

• Modified Barium Swallow Impairment profile (MBSImp)

  MBSImp is a 17-point assessment tool (0-55 points, a higher score indicates worse swallowing function) for interpreting MBSS that includes evaluation of the oral, pharyngeal and esophageal phase. The Penetration/Aspiration Scale will be applied for evaluating swallow safety ranging from 1 (no penetration/aspiration) to 8 (silent aspiration). The recordings as well as the interpretations are carried out by one of two trained otorhinolaryngologists.

  Baseline, 2 and 12 months post-operative

• MD Anderson Dysphagia Inventory (MDADI)

  The MDADI is a 20-item questionnaire assessing dysphagia-related QoL in head and neck cancer patients covering global, emotional, functional, and physical domains. The score ranges from 20 (poor function) to 100 (high function). The patient answers the questionnaire assisted by a nurse. A 10-point difference between groups in composite score is considered significant.

  Baseline, 2 and 12 months post-operative

• Days alive and out of hospital

  During regular outpatient follow-up, the patient will be asked about hospital admission/re-admission since the last visit and the electronic chart will be accessed for verification of reason and length of stay.

  12 months post-operative

Secondary Outcomes (4)

• Weight

  Baseline, 2 and 12 months post-operative

• European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30)

  Baseline, 2 and 12 months post-operative

• European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Head And Neck 35 (EORTC H&N-35)

  Baseline, 2 and 12 months post-operative

• Functional oral intake score (FOIS)

  Baseline, 2 and 12 months post-operative

Other Outcomes (1)

• Rehabilitation program

  12 months post-operatively

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

Squamous cell carcinoma with any location in the oral cavity

You may qualify if:

• Histologically confirmed squamous cell carcinoma with any location in the oral cavity including recurrences. Patients will only be included once
• Treatment with curative intent (surgery and/or (chemo)radio therapy)

You may not qualify if:

• Allergy to barium contrast
• Pregnancy or breastfeeding
• Inability or unwillingness to complete questionnaires and undergo examinations

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Aarhus University Hospital

Aarhus, Denmark

Location

MeSH Terms

Conditions

Mouth Neoplasms; Deglutition Disorders

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Central Study Contacts

Mathilde Aalling

CONTACT

4520258983; mathaall@rm.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2024
• First Posted: May 9, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: May 9, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)