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

May 7, 2024 updated by: University of Aarhus

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

One hundred patients treated for OCC will be included prospectively during a 2-year period. Data on type and location of tumour, treatment modality, complications, patient weight, dietary intake, rehabilitation program, hospital admissions, recurrences, and survival will be collected. Questionnaires and Modified Barium Swallow Study (MBSS) will be performed before and 2 and 12 months after treatment.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Mathilde Aalling
  • Phone Number: 4520258983
  • Email: mathaall@rm.dk

Study Locations

  • Denmark
      • Aarhus, Denmark
        • Aarhus University Hospital
        • Contact:
          • Mathilde Aalling

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Squamous cell carcinoma with any location in the oral cavity

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Barium Swallow Impairment profile (MBSImp)
Time Frame: Baseline, 2 and 12 months post-operative
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)
Time Frame: Baseline, 2 and 12 months post-operative
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
Time Frame: 12 months post-operative
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight
Time Frame: Baseline, 2 and 12 months post-operative
Bodyweight will be measured at each visit
Baseline, 2 and 12 months post-operative
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30)
Time Frame: Baseline, 2 and 12 months post-operative
Scoring ranges from 0-100 where a high score in the functioning scales and global QoL indicate better functioning but for the symptom scales higher scores indicate higher symptom burden. The patient answers the questionnaires assisted by a nurse. A 10-point difference in instrument score is considered significant
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)
Time Frame: Baseline, 2 and 12 months post-operative
Scoring ranges from 0-100 where a high score in the functioning scales and global QoL indicate better functioning but for the symptom scales higher scores indicate higher symptom burden. The patient answers the questionnaires assisted by a nurse. A 10-point difference in instrument score is considered significant
Baseline, 2 and 12 months post-operative
Functional oral intake score (FOIS)
Time Frame: Baseline, 2 and 12 months post-operative
The patient will be asked about their food intake at each visit. FOIS is a 7 point scale regarding the level of oral intake, ranging from total tube dependency (1) to oral intake of a normal diet (7).
Baseline, 2 and 12 months post-operative

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rehabilitation program
Time Frame: 12 months post-operatively
At the 12-month follow-up a questionnaire will be sent to the patient's occupational therapist addressing the offered rehabilitation program (type and frequency). Patient satisfaction will be measured on a 10-point VAS-scale.
12 months post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

May 30, 2027

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

April 22, 2024

First Submitted That Met QC Criteria

May 7, 2024

First Posted (Actual)

May 9, 2024

Study Record Updates

Last Update Posted (Actual)

May 9, 2024

Last Update Submitted That Met QC Criteria

May 7, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCOdysphagia

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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