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Dysphagia in Head and Neck Cancer With Radiation

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National Taiwan University

Status

Not yet enrolling

Conditions

Swallowing Function

Study type

Observational

Funder types

Other

Identifiers

NCT06747208
202410077DINE

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

50 participants in 1 patient group

head and neck cancer patients
Description:
patients with head and neck cancer undergoing radiation therapy

Trial contacts and locations

0

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Central trial contact

Chih-Jun Lai, MD

Data sourced from clinicaltrials.gov

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