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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2013 by Tehran University of Medical Sciences.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
Babak Saedi, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00497588
First received: July 4, 2007
Last updated: July 10, 2013
Last verified: July 2013
  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:


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: April 2014
Estimated Primary Completion Date: April 2014 (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

Ages Eligible for Study:   Child, Adult, Senior
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Iran, Islamic Republic of
Imam Khomainee hospital
Tehran, Iran, Islamic Republic of, 19799
Sponsors and Collaborators
Tehran University of Medical Sciences
Investigators
Principal Investigator: babak saedi, professor tehran university of medical science
  More Information

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: July 10, 2013
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 December 09, 2016