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

Voice Quality Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00497588
• Other study ID #: bs-86-01-48-5497
• Status: Recruiting
• Phase: Phase 3
• First received: July 4, 2007
• Last updated: July 10, 2013
• Start date: March 2007
• Est. completion date: April 2014

Study information

• Verified date: July 2013
• Source: Tehran University of Medical Sciences
• Contact: babak saedi, professor
• Phone: 98219123872469
• Email: saedi[@]tums.ac.ir
• Is FDA regulated: No
• Health authority: Iran: TUMS ethics committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 33
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Early laryngeal cancer

Exclusion Criteria:

• No history of radiotherapy and collagen vascular disease

Study Design

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

Related Conditions & MeSH terms

• Voice Quality

Intervention

Procedure:
• surgery

Radiation:
• radiotherapy

Locations

Country	Name	City	State
Iran, Islamic Republic of	Imam Khomainee hospital	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	quality of voice		3 to 6 month after therapy	No
Secondary	quality of life		6 month later	No