Dysphagia in Head and Neck Cancer With Radiation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-01

Study Completion Date

2031-12-31

Brief Summary

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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

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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.

Conditions

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Swallowing Function

Keywords

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dysphagia head and neck cancer radiation therapy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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head and neck cancer patients

patients with head and neck cancer undergoing radiation therapy

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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National Taiwan University Clinical Trial Center

Attending Anesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Chih-Jun Lai, MD

Role: CONTACT

Phone: +886-965327939

Email: [email protected]

Other Identifiers

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202410077DINE

Identifier Type: -

Identifier Source: org_study_id