Dysphagia and Quality of Life in Patients With Oral Squamous Cell Carcinoma Before and After Treatment
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Aarhus
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Allergy to barium contrast
Pregnancy or breastfeeding
Inability or unwillingness to complete questionnaires and undergo examinations
Trial population
Squamous cell carcinoma with any location in the oral cavity
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, 2 and 12 months post-operative2
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.
Time frame
Baseline, 2 and 12 months post-operative3
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.
Time frame
12 months post-operativeSecondary outcomes
1
Weight
Bodyweight will be measured at each visit
Time frame
Baseline, 2 and 12 months post-operative2
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30)
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
Time frame
Baseline, 2 and 12 months post-operative3
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Head And Neck 35 (EORTC H&N-35)
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
Time frame
Baseline, 2 and 12 months post-operative4
Functional oral intake score (FOIS)
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).
Time frame
Baseline, 2 and 12 months post-operativeOther outcomes
1
Rehabilitation program
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.
Time frame
12 months post-operativelySponsors and contacts
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Source ClinicalTrials.gov
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