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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06407570
• Other study ID #: CCOdysphagia
• Status: Not yet recruiting
• Start date: June 1, 2024
• Est. completion date: January 1, 2028

Study information

• Verified date: April 2024
• Source: University of Aarhus
• Contact: Mathilde Aalling
• Phone: 4520258983
• Email: mathaall[@]rm.dk
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: January 1, 2028
• Est. primary completion date: May 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Deglutition Disorders
• Dysphagia
• Mouth Neoplasms
• Oral Cavity Cancer
• Quality of Life
• Squamous Cell Carcinoma of Head and Neck

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	12 months post-operatively
Primary	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.	Baseline, 2 and 12 months post-operative
Primary	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.	Baseline, 2 and 12 months post-operative
Primary	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.	12 months post-operative
Secondary	Weight	Bodyweight will be measured at each visit	Baseline, 2 and 12 months post-operative
Secondary	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	Baseline, 2 and 12 months post-operative
Secondary	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	Baseline, 2 and 12 months post-operative
Secondary	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).	Baseline, 2 and 12 months post-operative