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

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ClinicalTrials.gov Identifier: NCT00497588
Recruitment Status : Unknown
Verified July 2013 by Babak Saedi, Tehran University of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : July 6, 2007
Last Update Posted : July 11, 2013
Sponsor:
Information provided by (Responsible Party):
Babak Saedi, Tehran University of Medical Sciences

Brief Summary:
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 or disease Intervention/treatment Phase
Voice Quality Procedure: surgery Radiation: radiotherapy Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : March 2007
Estimated Primary Completion Date : April 2014
Estimated Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: radiotherapy
patients receive radiotherapy
Radiation: radiotherapy
Experimental: surgery
Patients undergo surgery
Procedure: surgery



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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Early laryngeal cancer

Exclusion Criteria:

  • No history of radiotherapy and collagen vascular disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Babak Saedi, associate Professor, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT00497588     History of Changes
Other Study ID Numbers: bs-86-01-48-5497
First Posted: July 6, 2007    Key Record Dates
Last Update Posted: July 11, 2013
Last Verified: July 2013

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

Additional relevant MeSH terms:
Laryngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Laryngeal Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Otorhinolaryngologic Diseases