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

First Received: July 4, 2007 Last Updated: July 5, 2007 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 ,radiotherapy	Phase IV

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Surgery

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 ]

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

No publications provided

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

Keywords provided by Tehran University of Medical Sciences:

laryngeal cancer
RADIOTHERAPY
Voice Quality

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Otorhinolaryngologic Diseases
Neoplasms by Site
Otorhinolaryngologic Neoplasms

Respiratory Tract Diseases
Head and Neck Neoplasms
Laryngeal Neoplasms
Laryngeal Diseases

ClinicalTrials.gov processed this record on November 27, 2009