Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06407570

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Oral Cavity Cancer Deglutition Disorders Digestive System Diseases Dysphagia Esophageal Diseases Gastrointestinal Diseases Head and Neck Neoplasms Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Site Otorhinolaryngologic Diseases Pharyngeal Diseases Quality of Life Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aarhus University Hospital

Aarhus, Denmark

Location contact

Mathilde Aalling

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Weight

    Time frame: Baseline, 2 and 12 months post-operative

    Bodyweight will be measured at each visit

  2. 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

    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

  3. 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

    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

  4. Functional oral intake score (FOIS)

    Time frame: Baseline, 2 and 12 months post-operative

    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).

Other outcomes

  1. Rehabilitation program

    Time frame: 12 months post-operatively

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mathilde Aalling

CONTACT

[email protected]

4520258983

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
May 9, 2024
Registry last updated
May 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.