Oral MucositisNCT00549952
Observational Study of Anti-Cancer Therapy Induced Oral Mucositis in Korean Cancer Patients
An observational study of Oral Mucositis, run by Korea Otsuka Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
to survey oral mucositis after chemotherapy and Concurrent chemoradiotherapy in Korean cancer patients Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Oral Mucositis
- How many people
- Not given
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2007to Mar 2008
- Phase
- Observational
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with one cancer among head and neck cancer, esophageal cancer, breast cancer, colorectal cancer, gastric cancer, and non-small cell lung cancer, who are being treated or going to be treated as one between A and B A. Chemotherapy only B. Concurrent chemoradiotherapy
Who cannot join
- Patients who are pregnant or breast feeding, absent from effective(medically proven) contraceptive method for females of childbearing potential
- Patients with performance status of ECOG score is more than 3
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University hospital
Seoul, 110-744
Do-Youn Oh
About this study
to survey oral mucositis after chemotherapy and Concurrent chemoradiotherapy in Korean cancer patients
- Conditions
- Oral Mucositis
- Being tested
- no intervention study
- Medical subject headings
- Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no intervention studyOther
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence and severity of oral mucositis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2007 (estimated)
- Study startOct 2007
- Study completionMar 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral MucositisStudies 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
- Observational
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Otsuka Pharmaceutical Co., Ltd.
- Investigators
- Do-Youn Oh, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00549952
- Sponsor's protocol ID
- 256-KOB-0701
- Status last verified
- Oct 2007
- First submitted
- 25 Oct 2007
- Last updated
- 26 Oct 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Anti-Cancer Therapy Induced Oral Mucositis in Korean Cancer Patients
- ClinicalTrials.gov ID
- NCT00549952
- Acronym / sponsor ID
- 256-KOB-0701
- Conditions
- Oral Mucositis
- Study type
- Observational
- Recruitment status
- Unknown status
- Lead sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Otsuka Pharmaceutical Co., Ltd.
- Study start
- Oct 2007
- Study completion
- Mar 2008 (estimated)
- First posted
- 26 Oct 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.
to survey oral mucositis after chemotherapy and Concurrent chemoradiotherapy in Korean cancer patients
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients diagnosed with one cancer among head and neck cancer, esophageal cancer, breast cancer, colorectal cancer, gastric cancer, and non-small cell lung cancer, who are being treated or going to be treated as one between A and B A. Chemotherapy only B. Concurrent chemoradiotherapy
Key exclusion criteria (2 listed)
- Patients who are pregnant or breast feeding, absent from effective(medically proven) contraceptive method for females of childbearing potential
- Patients with performance status of ECOG score is more than 3
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 |
|---|---|---|
| no intervention study | Other | – |
Primary outcome
incidence and severity of oral mucositis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2007.
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High-dose Prophylactic Gabapentin (HOPE) vs. Placebo to Prevent Opioid Use for Oral Mucositis Pain During Concurrent Chemoradiation for Head and Neck Cancer
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Evaluation of 25(OH)D3 and LL-37 Levels in Periimplant Sulcus Fluid
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Taurine for the Prevention and Treatment of Radiation-induced Oral Mucositis in Patients With Nasopharyngeal Carcinoma
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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.
Do-Youn Oh, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Mucositis, run by Korea Otsuka Pharmaceutical Co., Ltd. at 1 site in South Korea.
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 2 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 26 Oct 2007. 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 South Korea. 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.
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 Yonghui Jeong (82-2-3465-3956, jeongyh@otsuka.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence and severity of oral mucositis. 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 26 Oct 2007.