Dysphagia and Quality of Life in Patients With Oral Squamous Cell Carcinoma Before and After Treatment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Oral Cavity Cancer, Dysphagia, Quality of Life. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Modified Barium Swallow Impairment profile (MBSImp) [Time frame: Baseline, 2 and 12 months post-operative]
- MD Anderson Dysphagia Inventory (MDADI) [Time frame: Baseline, 2 and 12 months post-operative]
- Days alive and out of hospital [Time frame: 12 months post-operative]
Secondary outcome measures (4)
- Weight [Time frame: 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]
- 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]
- Functional oral intake score (FOIS) [Time frame: Baseline, 2 and 12 months post-operative]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Denmark · 1 center
- Aarhus University Hospital — Aarhus
Identifiers
NCT: NCT06407570 · CCOdysphagia