Dysphagia in Head and Neck Cancer With Radiation

NCT06747208 | Not Yet Recruiting DMC

• 1 other identifier: 202410077DINE
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Swallowing Function

Keywords

dysphagia; head and neck cancer; radiation therapy

Outcome Measures

Primary Outcomes (1)

• hypopharyngeal mean peak pressure

  hypopharyngeal contraction

  one year

Study Arms (1)

head and neck cancer patients

patients with head and neck cancer undergoing radiation therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with head and neck cancer undergoing radiation therapy

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Biospecimen

Retention: SAMPLES WITH DNA

the DNA associated with nutrition

MeSH Terms

Conditions

Deglutition Disorders; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Neoplasms by Site; Neoplasms

Central Study Contacts

Chih-Jun Lai, MD

CONTACT

+886-965327939; littlecherrytw@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Anesthesiologist

Study Record Dates

• First Submitted: December 15, 2024
• First Posted: December 24, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2031
• Last Updated: December 24, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share