Clinical trial NCT06747208: Dysphagia in Head and Neck Cancer With Radiation
Official title: The Impact of Swallowing and Nutrition in Head and Neck Cancer Patients Undergoing Chemo or Chemo-radiotherapy.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Swallowing Function
Keywords: dysphagia
head and neck cancer
radiation therapy
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2024-12-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with head and neck cancer undergoing radiation therapy

Brief summary: This study focuses on swallowing dysfunction, a common issue affecting 60-75% of head and neck cancer patients due to tumor damage, treatment complications, and chemoradiotherapy side effects, which can lead to malnutrition and reduced quality of life. With limited research on the effects of radiation doses on swallowing muscles and nutrition, this study aims to evaluate these impacts in non-surgical patients undergoing radiotherapy, conducting assessments before treatment, three months after, and within one year post-treatment.

Detailed description: Swallowing dysfunction is a common and debilitating symptom in head and neck cancer patients, affecting approximately 60-75% during the disease course, primarily due to tumor destruction, postoperative complications, and side effects of radiotherapy and chemotherapy. Combined chemoradiotherapy exacerbates adverse effects, such as mucositis, odynophagia, taste alterations, xerostomia, nausea, vomiting, and fatigue, which can result in dehydration, significant weight loss, and detrimental impacts on nutritional status, functionality, and quality of life. Limited research exists on the effects of radiation and chemoradiation doses on swallowing muscles, quality of life, and nutritional changes in these patients. This study aims to evaluate the impact of radiation doses on swallowing muscles and quality of life in head and neck cancer patients undergoing chemoradiotherapy while identifying malnutrition risk in this population. Non-surgical patients receiving radiotherapy as the primary treatment will be recruited, with swallowing, muscle, and nutritional assessments conducted before treatment, three months after treatment, and within one year post-treatment.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled to undergo radiotherapy or concurrent chemoradiotherapy ;
* Aged between 18 and 80 years;
* Able to perform self-care independently (ECOG ≤ 2);
* All patients provide written informed consent.

Exclusion Criteria:

* Patients scheduled to undergo surgical treatment;
* Patients with neuromuscular diseases, such as stroke or Parkinson's disease;
* Patients with other diseases or complications, including heart disease classified as NYHA functional class ≥ 2 with thrombotic conditions, or lung disease classified as Hugh-Jones grade ≥ 4;
* Patients with psychological disorders that may affect their ability to provide informed consent or comply with the study protocol;
* Patients who do not consent to undergo high-resolution impedance manometry.

Primary outcomes:
measure: hypopharyngeal mean peak pressure
timeFrame: one year
Secondary outcomes:
Other outcomes:
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Study officials:
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