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CompletedNCT06348485Updated Apr 4, 2024

Massive Nasal Bleeding in Patients With NPC Received Curative RT

An observational study in Nasopharyngeal Carcinoma Patients Treated With Curative Radiotherapy, sponsored by Taichung Veterans General Hospital. Completed at 1 site in Taiwan. Per ClinicalTrials.gov, last updated 2024-04-04.

Sponsored by Taichung Veterans General Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
1,327
Sex
All
01

Study summary

To investigate the incidence, predictive markers, and survival impact of massive nasal bleeding in nasopharyngeal carcinoma (NPC) patients who received curative radiotherapy (RT) with/without chemotherapy. A total of 1327 patients with previously untreated, biopsy-proven NPC, and no distant metastasis were retrospective reviewed. Investigators analyzed the occurrence rates of massive nasal bleeding between different characteristics and tried to identify important predictive factors. Investigators compared overall survival between patients with and without massive nasal bleeding by Kaplan-Meier method.

02

Conditions studied

  • Nasopharyngeal Carcinoma Patients Treated With Curative Radiotherapy
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

A total of 1327 patients with previously untreated, biopsy-proven NPC, and no distant metastasis were retrospective reviewed. There are 957 males and 370 females received conventional 2D or 3D conformal radiotherapy.

Inclusion criteria

  • previously untreated, biopsy-proven NPC
  • no distant metastasis

Exclusion criteria

Exclusion Criteria:

  • incomplete record of history or treatment
04

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
1,327 participants (actual)
Patient registry
No

Groups and cohorts

  • NPC received Curative radiotherapy

    Other: Patients without massive nasal bleeding · Other: Patients with massive nasal bleeding

Interventions

  • OtherPatients without massive nasal bleeding

    No event of massive nasal bleeding after curative radiotherapy

  • OtherPatients with massive nasal bleeding

    Any event of massive nasal bleeding after curative radiotherapy

05

What researchers measure

Primary outcomes

  1. Massive Nasal Bleeding Rate

    Massive Nasal Bleeding Rate among different characteristics. Massive Nasal Bleeding was defined as unique blood loss \> 300 ml or recurrent blood losses \> 100 ml.

    Time frame: From date of radiotherapy until the date of first documented massive bleeding, assessed up to 360 months

Secondary outcomes

  1. Overall Survival

    Overall Survival

    Time frame: From date of radiotherapy until the date of last clinic visit or date of death from any cause, whichever came first, assessed up to 360 months

06

Study locations

1 site
  • Taichung Veterans General Hospital
    Taichung, 407, Taiwan
07

References and documents

Publications

  • Huang Y, Yan D, Wang M, Chen S, Yang F. Clinicopathological factors affecting the prognosis of massive hemorrhage after radiotherapy for patients having nasopharyngeal carcinoma. J Cancer Res Ther. 2021 Nov;17(5):1219-1224. doi: 10.4103/jcrt.jcrt_586_21. PubMed 34850770 ↗
  • Zhan J, Zhang S, Wei X, Fu Y, Zheng J. Etiology and management of nasopharyngeal hemorrhage after radiotherapy for nasopharyngeal carcinoma. Cancer Manag Res. 2019 Mar 15;11:2171-2178. doi: 10.2147/CMAR.S183537. eCollection 2019. PubMed 30936749 ↗
  • Li J, Yi X, He G, Yao D, Bin X, Feng Y, Niu Z, Tan Q, Tang A. Analysis of the risk of death and clinical management for nasal or nasopharyngeal bleeding occurring after radiotherapy for nasopharyngeal carcinoma. Auris Nasus Larynx. 2022 Aug;49(4):703-708. doi: 10.1016/j.anl.2022.01.006. Epub 2022 Jan 20. PubMed 35065845 ↗
  • Zeng L, Wan W, Luo Q, Jiang H, Ye J. Retrospective analysis of massive epistaxis and pseudoaneurysms in nasopharyngeal carcinoma after radiotherapy. Eur Arch Otorhinolaryngol. 2022 Jun;279(6):2973-2980. doi: 10.1007/s00405-021-07111-x. Epub 2021 Oct 8. PubMed 34623497 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT06348485
Lead sponsor
Taichung Veterans General Hospital
Responsible party
Hao-Shen Cheng (Attending Physician, Taichung Veterans General Hospital) — Principal investigator
First posted
Apr 4, 2024
Start date
Dec 1, 1994
Primary completion
Apr 30, 2019
Completion
Feb 29, 2024
Last update
Apr 4, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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