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

This study is currently recruiting participants.

Verified November 2010 by Tehran University of Medical Sciences

First Received on July 4, 2007. Last Updated on November 17, 2010 History of Changes

Sponsor:	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 Radiation: radiotherapy	Phase III

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 2010
Estimated Primary Completion Date:	December 2009 (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:	Vice-Chancellor for Research, 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:	November 17, 2010
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 February 12, 2012