Dysphagia in Head and Neck Cancer With Radiation

The Impact of Swallowing and Nutrition in Head and Neck Cancer Patients Undergoing Chemo or Chemo-radiotherapy.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Swallowing Function

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.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Chih-Jun Lai, MD; Phone Number: +886-965327939; Email: littlecherrytw@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patients with head and neck cancer undergoing radiation therapy

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
head and neck cancer patients; patients with head and neck cancer undergoing radiation therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hypopharyngeal mean peak pressure	hypopharyngeal contraction	one year

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2031

Study Registration Dates

• First Submitted: December 15, 2024
• First Submitted That Met QC Criteria: December 18, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: head and neck cancer; radiation therapy; dysphagia
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Head and Neck Neoplasms
• Other Study ID Numbers: 202410077DINE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: due to ethical issue

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No