Oral and Esophageal CancerNCT02175524
The Association Between Areca-nut Chewing Habit and Metabolic Syndrome
An observational study of Oral and Esophageal Cancer and Metabolic Syndrome., run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is going to determine the odds ratio of metabolic syndrome (MS), the habit of areca nut chewing, antioxidant, and inflammatory status in oral and esophageal patients. The current study was designed as a case-control study. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Oral and Esophageal Cancer, Metabolic Syndrome.
- Type of treatment
- Pill or oral medicine
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2014to Dec 2017
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with oral and oesophageal carcinoma.
Who may be able to join
- Patients proved to be oral and esophageal cancer will be recruited.
Who cannot join
- Subjects with diabetes mellitus, liver, renal diseases, or undergoing statin therapy.
- Taking antioxidant vitamins supplements.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taichung Verterans General Hospital
Taichung, 40705
Ping-Ting Lin, Ph.D., +886-24730022 ext. 12187, apt810@csmu.edu.tw
Bore-Jen Lee, Ph.D., +886-23592525 ext. 3190, borjen@vghtc.gov.tw
About this study
The purpose of this study is going to determine the odds ratio of metabolic syndrome (MS), the habit of areca nut chewing, antioxidant, and inflammatory status in oral and esophageal patients. The current study was designed as a case-control study. Patients proved to be oral and esophageal cancer and had the habit of areca nut chewing are defined as case group. Patients proved to be oral and esophageal cancer and did not have the habit of areca nut chewing are defined as control group. The participants' age, blood pressures, and smoking habits will be recorded. Body weight, height, waist, and hip circumferences will be measured. Fasting venous blood samples will be obtained to determine hematological parameters [i.e., serum creatinine, total cholesterol, triacylglycerol, low density lipoprotein-cholesterol, high density lipoprotein-cholesterol, malondialdehyde, superoxide dismutase, glutathione peroxidase, catalase, and inflammatory markers (C-reactive protein, tumor necrosis factor-alpha, and interleukin-6)]. Logistic regression analyses are going to perform to examine the relationship between areca nut chewing and MS in this population. If we can make sure the relationship between areca nut chewing and MS, the clinicians and nutritionists can teach people to quit areca nut chewing in order to avoid the possibility of developing metabolic syndrome and cardiovascular disease.
- Conditions
- Oral and Esophageal Cancer, Metabolic Syndrome.
- Keywords
- nut chewing
- Medical subject headings
- Esophageal Neoplasms, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Case | Patients proved to be oral and esophageal cancer and had the habit of areca nut chewing. | |
| Control | Patients proved to be oral and esophageal cancer and did not have the habit of areca nut chewing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic syndrome
Measure blood pressure, blood lipid profiles, fasting glucose, and waist circumferences.
Measured: Up to 1 week
Secondary outcomes (2)
Antioxidant activity
Antioxidant ability measurements: lipid peroxidation markers (MDA), antioxidant enzymes activities (catalase, glutathione peroxidase, and superoxide dismutase).
Measured: Up to 1 week
Inflammatory status
Measure inflammatory markers: C-reactive protein, Interleukin-6, and tumor necrosis factor-alpha.
Measured: Up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2014 (estimated)
- Study startApr 2014
- Primary completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral and Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe sponsor's other registered studies.
- 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
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02175524
- Sponsor's protocol ID
- CF13341
- Status last verified
- Jun 2014
- First submitted
- 24 Jun 2014
- Last updated
- 26 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Areca-nut Chewing Habit and Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT02175524
- Acronym / sponsor ID
- CF13341
- Conditions
- Oral and Esophageal Cancer, Metabolic Syndrome.
- Keywords
- nut chewing
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Dec 2017 (estimated)
- First posted
- 26 Jun 2014 (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.
The purpose of this study is going to determine the odds ratio of metabolic syndrome (MS), the habit of areca nut chewing, antioxidant, and inflammatory status in oral and esophageal patients. The current study was designed as a case-control study. Patients proved to be oral and esophageal cancer and had the habit of areca nut chewing are defined as case group. Patients proved to be oral and esophageal cancer and did not have the habit of areca nut chewing are defined as control group. The participants' age, blood pressures, and smoking habits will be recorded. Body weight, height, waist, and hip circumferences will be measured. Fasting venous blood samples will be obtained to determine hematological parameters [i.e., serum creatinine, total cholesterol, triacylglycerol, low density lipoprotein-cholesterol, high density lipoprotein-cholesterol, malondialdehyde, superoxide dismutase, glutathione peroxidase, catalase, and inflammatory markers (C-reactive protein, tumor necrosis factor-alpha, and interleukin-6)]. Logistic regression analyses are going to perform to examine the relationship between areca nut chewing and MS in this population. If we can make sure the relationship between areca nut chewing and MS, the clinicians and nutritionists can teach people to quit areca nut chewing in order to avoid the possibility of developing metabolic syndrome and cardiovascular disease.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | –Patients proved to be oral and esophageal cancer and had the habit of areca nut chewing. |
| Control | – | –Patients proved to be oral and esophageal cancer and did not have the habit of areca nut chewing. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with oral and oesophageal carcinoma.
Key inclusion criteria (1 listed)
- Patients proved to be oral and esophageal cancer will be recruited.
Key exclusion criteria (2 listed)
- Subjects with diabetes mellitus, liver, renal diseases, or undergoing statin therapy.
- Taking antioxidant vitamins supplements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Metabolic syndrome
Time frame: Up to 1 week
Measure blood pressure, blood lipid profiles, fasting glucose, and waist circumferences.
2 secondary outcomes
Antioxidant activity
Time frame: Up to 1 week
Inflammatory status
Time frame: Up to 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2014.
Related trials for Oral and Esophageal Cancer
RecruitingPhase 1/2
Beamion BCGC-1: A Study to Find a Suitable Dose of Zongertinib Used Alone and in Combination With Other Treatments to Test Whether it Helps People With Different Types of HER2+ Cancer That Has Spread
Metastatic Breast Cancer, Metastatic Gastric Adenocarcinoma
RecruitingPhase 1/2
VMD-928 Monotherapy and in Combination With Pembrolizumab to Treat TrkA Overexpression Driven Solid Tumors or Lymphoma
Head and Neck Carcinoma, Adenoid Cystic Carcinoma
RecruitingPhase 2
A Study to Learn More About How Well Treatment With Sevabertinib (BAY 2927088) Tablets Works and How Safe it is in Participants Who Have a Solid Tumor With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)
Advanced Solid Tumors, HER2 Mutation
RecruitingPhase 2
A Phase 2 Study of Zanidatamab in Patients With HER2-expressing Tumors
Breast Cancer, Gastric Cancer
RecruitingObservational study
Biomarkers in Patients With Respiratory Tract Dysplasia or Lung Cancer, Head and Neck Cancer, or Aerodigestive Tract Cancer and in Normal Volunteers
Esophageal Cancer, Head and Neck Cancer
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.
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 and Esophageal Cancer and Metabolic Syndrome., run by Taichung Veterans General Hospital at 1 site in Taiwan.
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 Jun 2014. 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 Taiwan. 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 Ping-Ting Lin, Ph.D. (+886-4-23470022 ext. 12187, apt810@csmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic syndrome (time frame: Up to 1 week). 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 Jun 2014.