Voice QualityPhase 3NCT00497588
the Comparison of Voice Quality in Early Laryngeal Cancer Between Surgery and Radiotherapy
A Phase 3 study testing surgery and radiotherapy in people with Voice Quality, run by Tehran University of Medical Sciences at 1 site in Iran.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Voice Quality
- What is being tested?
- surgery and radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteIran
- Study dates
- Mar 2007to Apr 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Early laryngeal cancer
Who cannot join
- No history of radiotherapy and collagen vascular disease
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Imam Khomainee hospital
Tehran, Tehran Province, 19799
babak saedi, professor, 98219123872469, saedi@tums.ac.ir
Mohamad sadeghi, professor, 98219121153594, sadeghi@tums.ac.ir
About this study
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.
Read the 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.
- Conditions
- Voice Quality
- Being tested
- surgery, radiotherapy
- Keywords
- laryngeal cancer, RADIOTHERAPY, Voice Quality
- Medical subject headings
- Laryngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgeryProcedure or surgery
radiotherapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| radiotherapy | Active comparator | patients receive radiotherapy Receives: Radiation: radiotherapy |
| surgery | Experimental | Patients undergo surgery Receives: Procedure: surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of voice
Measured: 3 to 6 month after therapy
Secondary outcomes (1)
quality of life
Measured: 6 month later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2007 (estimated)
- Study startMar 2007
- Primary completionApr 2014 (estimated)
- Study completionApr 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Voice QualityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Babak Saedi, Tehran University of Medical Sciences
- Investigators
- babak saedi, professor, Principal investigator, tehran university of medical science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00497588
- Sponsor's protocol ID
- bs-86-01-48-5497
- Status last verified
- Jul 2013
- First submitted
- 4 Jul 2007
- Last updated
- 11 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Comparison of Voice Quality in Early Laryngeal Cancer Between Surgery and Radiotherapy
- ClinicalTrials.gov ID
- NCT00497588
- Acronym / sponsor ID
- bs-86-01-48-5497
- Conditions
- Voice Quality
- Keywords
- laryngeal cancer, RADIOTHERAPY, Voice Quality
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Apr 2014 (estimated)
- Study completion
- Apr 2014 (estimated)
- First posted
- 6 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| radiotherapy | Active comparator | Radiation: radiotherapypatients receive radiotherapy |
| surgery | Experimental | Procedure: surgeryPatients undergo surgery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Early laryngeal cancer
Key exclusion criteria (1 listed)
- No history of radiotherapy and collagen vascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surgery | Procedure or surgery | surgery |
| radiotherapy | Radiation | radiotherapy |
Primary outcome
quality of voice
Time frame: 3 to 6 month after therapy
1 secondary outcome
quality of life
Time frame: 6 month later
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
babak saedi, professor principal investigator
tehran university of medical science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing surgery and radiotherapy in people with Voice Quality, run by Tehran University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact babak saedi, professor (98219123872469, saedi@tums.ac.ir), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quality of voice (time frame: 3 to 6 month after therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2013.