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the Comparison of Voice Quality in Early Laryngeal Cancer Between Surgery and Radiotherapy

This study is currently recruiting participants.
Verified by Tehran University of Medical Sciences, May 2007

Sponsored by: Tehran University of Medical Sciences
Information provided by: Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT00497588
  Purpose

early laryngeal cancer is a well known field with great controversy in treatment. two options are available in treatment of patients the first one is partial laryngectomy and the second one is radiotherapy.one of major concern of patients have been the quality of voice ,so we design this trial to answer the priority of each options.


Condition Intervention Phase
Voice Quality
Procedure: surgery ,radiotherapy
Phase IV

MedlinePlus related topics:   Cancer   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:
  • quality of voice [ Time Frame: 3 to 6 month after therapy ]

Secondary Outcome Measures:
  • quality of life [ Time Frame: 6 month later ]

Estimated Enrollment:   33
Study Start Date:   March 2007
Estimated Study Completion Date:   December 2009

Detailed Description:

early laryngeal cancer is a well known field with great controversy in treatment. two options are available in treatment of patients the first one is partial laryngectomy and the second one is radiotherapy.one of major concern of patients have been the quality of voice as part of quality of life ,so we design this clinical randomised trial to answer the priority of each options.

  Eligibility
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Early laryngeal cancer

Exclusion Criteria:

  • No history of radiotherapy and collagen vascular disease
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00497588

Contacts
Contact: babak saedi, professor     98219123872469     saedi@tums.ac.ir    
Contact: mohamad sadeghi, professor     98219121153594     sadeghi@tums.ac.ir    

Locations
Iran, Islamic Republic of
Imam Khomainee hospital     Recruiting
      Tehran, Iran, Islamic Republic of, 19799
      Contact: babak saedi, professor     98219123872469     saedi@tums.ac.ir    
      Contact: Mohamad sadeghi, professor     98219121153594     sadeghi@tums.ac.ir    
      Sub-Investigator: Mohamad sadeghi, professor            

Sponsors and Collaborators
Tehran University of Medical Sciences

Investigators
Principal Investigator:     babak saedi, professor     tehran university of medical science    
  More Information

Study ID Numbers:   bs-86-01-48-5497
First Received:   July 4, 2007
Last Updated:   July 5, 2007
ClinicalTrials.gov Identifier:   NCT00497588
Health Authority:   Iran: TUMS ethics committee

Keywords provided by Tehran University of Medical Sciences:
laryngeal cancer  
RADIOTHERAPY  
Voice Quality  

Study placed in the following topic categories:
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Respiratory Tract Diseases
Head and Neck Neoplasms
Laryngeal carcinoma
Laryngeal Neoplasms
Laryngeal Diseases

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on September 05, 2008




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