Thyroid CancerNCT01811199
Dexamethasone Reduces Postoperative Emesis by Decreasing PGF2α and LTC4 Levels
An observational study of Thyroid Cancer and Breast Cancer, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
Hypothesis: Dexamethasone reduces postoperative emesis in thyroidectomy and mastectomy patients. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Thyroid Cancer, Breast Cancer
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Feb 2011to May 2013
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undergoing thyroidectomy and mastectomy
Who may be able to join
- breast and thyroid cancer patients no neoadjuvant treated no NSAID or steroid usage heallthy volunteers, signed the informed consent
Who cannot join
- ones who did not sign the consent form NSAID or steroid users
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University School of Medicine
Istanbul
About this study
Hypothesis: Dexamethasone reduces postoperative emesis in thyroidectomy and mastectomy patients.
Read the detailed description
This study has been done to further study the effectiveness of dexamethasone in the prevention of postoperative emesis after breast and thyroid surgery and at the same time, the mechanism of action was investigated. In this prospective, randomized controlled trial it was hypothesized that corticosteroids exert their antiemetic effects in postoperative period via plasma prostaglandin F2 alpha (PGF2 α) and plasma leukotriene C4 (LTC4) inhibition.
- Conditions
- Thyroid Cancer, Breast Cancer
- Keywords
- Thyroid cancer, Breast cancer, Dexamethasone, Emesis
- Medical subject headings
- Thyroid Neoplasms, Breast Neoplasms, Vomiting
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants will be evaluated to show effect of dexamethasone in reducing postoperative emesis
participants will be followed for the duration of hospital stay, till they are discharged in avarage 3 days for postoperative emesis.
Measured: up to 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2013 (estimated)
- Study startFeb 2011
- Primary completionApr 2013 (estimated)
- Study completionMay 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, A.Ozdemir Aktan, Marmara University
- Investigators
- A.Ozdemir Aktan, MD,prof, Principal investigator, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01811199
- Sponsor's protocol ID
- 09.2011.0024
- Status last verified
- Mar 2013
- First submitted
- 6 Mar 2013
- Last updated
- 14 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexamethasone Reduces Postoperative Emesis by Decreasing PGF2α and LTC4 Levels
- ClinicalTrials.gov ID
- NCT01811199
- Acronym / sponsor ID
- 09.2011.0024
- Conditions
- Thyroid Cancer, Breast Cancer
- Keywords
- Thyroid cancer, Breast cancer, Dexamethasone, Emesis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Apr 2013 (estimated)
- Study completion
- May 2013 (estimated)
- First posted
- 14 Mar 2013 (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.
Hypothesis: Dexamethasone reduces postoperative emesis in thyroidectomy and mastectomy patients.
Detailed description
This study has been done to further study the effectiveness of dexamethasone in the prevention of postoperative emesis after breast and thyroid surgery and at the same time, the mechanism of action was investigated. In this prospective, randomized controlled trial it was hypothesized that corticosteroids exert their antiemetic effects in postoperative period via plasma prostaglandin F2 alpha (PGF2 α) and plasma leukotriene C4 (LTC4) inhibition.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing thyroidectomy and mastectomy
Key inclusion criteria (1 listed)
- breast and thyroid cancer patients no neoadjuvant treated no NSAID or steroid usage heallthy volunteers, signed the informed consent
Key exclusion criteria (1 listed)
- ones who did not sign the consent form NSAID or steroid users
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
Number of participants will be evaluated to show effect of dexamethasone in reducing postoperative emesis
Time frame: up to 3 days
participants will be followed for the duration of hospital stay, till they are discharged in avarage 3 days for postoperative emesis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 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.
A.Ozdemir Aktan, MD,prof principal investigator
Marmara University
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 Thyroid Cancer and Breast Cancer, run by Marmara University at 1 site in Turkey (Türkiye).
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 14 Mar 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 Turkey (Türkiye). 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants will be evaluated to show effect of dexamethasone in reducing postoperative emesis (time frame: up to 3 days). 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 14 Mar 2013.