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

This study is currently recruiting participants.
Verified June 2012 by Tehran University of Medical Sciences
Sponsor:
Information provided by (Responsible Party):
Babak Saedi, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00497588
First received: July 4, 2007
Last updated: June 2, 2012
Last verified: June 2012
History of Changes
  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
Radiation: radiotherapy
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • quality of life [ Time Frame: 6 month later ] [ Designated as safety issue: No ]

Estimated Enrollment: 33
Study Start Date: March 2007
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: radiotherapy
patients receive radiotherapy
 Radiation: radiotherapy
Experimental: surgery
Patients undergo surgery
 Procedure: surgery

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

No publications provided

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
Study First Received: July 4, 2007
Last Updated: June 2, 2012
Health Authority: Iran: TUMS ethics committee

Keywords provided by 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

ClinicalTrials.gov processed this record on May 21, 2013