Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06407570
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-09
First Post:
2024-04-22
Brief Title:
Dysphagia and Quality of Life in Patients With Oral Squamous Cell Carcinoma Before and After Treatment
Sponsor:
University of Aarhus
Organization:
University of Aarhus
Study Overview
Official Title:
Dysphagia and Quality of Life in Patients With Oral Squamous Cell Carcinoma Before and After Treatment
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None