NCT00173836

Brief Summary

Significant evidence has shown that radiation therapy for patients with nasopharyngeal cancer (NPC) can cause swallowing abnormality. Based on our prior cross-sectional study for 184 NPC patients from 1995 to 1999, the findings of videofluoroscopic swallowing study (VFSS) revealed continuous deterioration of swallowing function of these patients even many years after radiation. We conducted a prospective study to evaluate the longitudinal change of swallowing function based on VFSS before, one month, one year and two years after completing radiation therapy. The amount of saliva was measured at the same time of VFSS study to test the relationship of decreased amount of saliva and swallowing function. Comparison of serial VFSS studies in NPC patients (n=84) and normal volunteers (n=38) were obtained. We assume that this study may reveal a complete understanding of changing swallowing patterns in the course of radiation therapy of patients with NPC. From this study, NPC patients can understand their own swallowing function. Therefore, the information may enable for earlier intervention of swallowing training or correction to avoid morbidity of radiation therapy in this patient group.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2003

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

September 9, 2009

Status Verified

August 1, 2009

Enrollment Period

3 years

First QC Date

September 13, 2005

Last Update Submit

September 4, 2009

Conditions

Keywords

Nasopharyngeal carcinomaSalivaSwallowingVideofluoroscopyRadiation

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Nasopharyngeal cancer patients

You may qualify if:

  • Nasopharyngeal cancer patients \> 20 yrs.

You may not qualify if:

  • pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

X-ray fluoroscopy

Taipei, 100, Taiwan

Location

Related Publications (1)

  • Chang YC, Chen SY, Lui LT, Wang TG, Wang TC, Hsiao TY, Li YW, Lien IN. Dysphagia in patients with nasopharyngeal cancer after radiation therapy: a videofluoroscopic swallowing study. Dysphagia. 2003 Spring;18(2):135-43. doi: 10.1007/s00455-002-0096-x.

    PMID: 12825907BACKGROUND

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNasopharyngeal NeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Yeun-Chung Chang, M.D., Ph.D.

    National Taiwan Univserity Hospital and College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 15, 2005

Study Start

August 1, 2003

Primary Completion

August 1, 2006

Study Completion

August 1, 2006

Last Updated

September 9, 2009

Record last verified: 2009-08

Locations