Oral Cavity CancerNCT06407570
Dysphagia and Quality of Life in Patients With Oral Squamous Cell Carcinoma Before and After Treatment
An observational study of Oral Cavity Cancer and Dysphagia, run by University of Aarhus at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Cavity Cancer, Dysphagia, Quality of Life
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jun 2024to 1 Jan 2028
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Squamous cell carcinoma with any location in the oral cavity
Who may be able to join
- 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)
Who cannot join
- Allergy to barium contrast
- Pregnancy or breastfeeding
- Inability or unwillingness to complete questionnaires and undergo examinations
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
With an overall goal to improve the QoL and health status in patients treated for OCC, the present study aims to
- systematically evaluate the swallowing function before and after treatment,
- investigate the impact of swallowing function on QoL,
- identify risk factors for dysphagia,
- investigate if swallowing function is an independent factor for the number of ´days alive and out of hospital´
- 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.
- Conditions
- Oral Cavity Cancer, Dysphagia, Quality of Life
- Keywords
- Oral Cavity Cancer, Dysphagia, Quality of Life, Days alive and out of hospital, Rehabilitation
- Medical subject headings
- Mouth Neoplasms, Deglutition Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 2 and 12 months post-operative
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.
Measured: Baseline, 2 and 12 months post-operative
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.
Measured: 12 months post-operative
Secondary outcomes (4)
Weight
Bodyweight will be measured at each visit
Measured: Baseline, 2 and 12 months post-operative
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
Measured: 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)
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
Measured: Baseline, 2 and 12 months post-operative
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).
Measured: Baseline, 2 and 12 months post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start1 Jun 2024 (estimated)
- Primary completion30 May 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Cavity CancerStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06407570
- Sponsor's protocol ID
- CCOdysphagia
- Status last verified
- Apr 2024
- First submitted
- 22 Apr 2024
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dysphagia and Quality of Life in Patients With Oral Squamous Cell Carcinoma Before and After Treatment
- ClinicalTrials.gov ID
- NCT06407570
- Acronym / sponsor ID
- CCOdysphagia
- Conditions
- Oral Cavity Cancer, Dysphagia, Quality of Life
- Keywords
- Oral Cavity Cancer, Dysphagia, Quality of Life, Days alive and out of hospital, Rehabilitation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 9 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- systematically evaluate the swallowing function before and after treatment,
- investigate the impact of swallowing function on QoL,
- identify risk factors for dysphagia,
- investigate if swallowing function is an independent factor for the number of ´days alive and out of hospital´
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Squamous cell carcinoma with any location in the oral cavity
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (3 listed)
- Allergy to barium contrast
- Pregnancy or breastfeeding
- Inability or unwillingness to complete questionnaires and undergo examinations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Modified Barium Swallow Impairment profile (MBSImp)
Time frame: Baseline, 2 and 12 months post-operative
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.
MD Anderson Dysphagia Inventory (MDADI)
Time frame: Baseline, 2 and 12 months post-operative
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.
Days alive and out of hospital
Time frame: 12 months post-operative
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Cavity Cancer and Dysphagia, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mathilde Aalling (4520258983, mathaall@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Barium Swallow Impairment profile (MBSImp) (time frame: Baseline, 2 and 12 months post-operative). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.