Clinical trial NCT06407570: Dysphagia and Quality of Life in Patients With Oral Squamous Cell Carcinoma Before and After Treatment
Official title: Dysphagia and Quality of Life in Patients With Oral Squamous Cell Carcinoma Before and After Treatment
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Oral Cavity Cancer
Dysphagia
Quality of Life
Keywords: Oral Cavity Cancer
Dysphagia
Quality of Life
Days alive and out of hospital
Rehabilitation
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2024-05-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Squamous cell carcinoma with any location in the oral cavity

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. 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: 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

Primary outcomes:
measure: Modified Barium Swallow Impairment profile (MBSImp)
timeFrame: Baseline, 2 and 12 months post-operative
measure: MD Anderson Dysphagia Inventory (MDADI)
timeFrame: Baseline, 2 and 12 months post-operative
measure: Days alive and out of hospital
timeFrame: 12 months post-operative
Secondary outcomes:
measure: Weight
timeFrame: Baseline, 2 and 12 months post-operative
measure: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30)
timeFrame: Baseline, 2 and 12 months post-operative
measure: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Head And Neck 35 (EORTC H&N-35)
timeFrame: Baseline, 2 and 12 months post-operative
measure: Functional oral intake score (FOIS)
timeFrame: Baseline, 2 and 12 months post-operative
Other outcomes:
measure: Rehabilitation program
timeFrame: 12 months post-operatively
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
References: