DexamethasoneNCT01277731
Methylprednisolone Replacement for Dexamethasone-induced Hiccup
A study testing Methylprednisolone in people with Dexamethasone and Hiccup, run by Gyeongsang National University Hospital at 1 site in South Korea.
Trial summary
Dexamethasone is a potent synthetic member of the corticosteroid. It is given to cancer patients undergoing chemotherapy to counteract emetic side effect and essential drug for the chemotherapy-treated patients. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Dexamethasone, Hiccup
- What is being tested?
- Methylprednisolone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2010to Dec 2011
- Phase
- Interventional
- 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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age olderthan 21
- A Patient on chemotherapy who was diagnosed malignant tumor
- A Patient who is newly developed hiccup in the course of chemotherapy
- A patient with the willingness to comply with the study protocol during the study period and capable of ccomplying with it
- A patient who signed the imformed consent prior to the participation of the study and who understands that he/she has a right to withdrawal from participation in the study at any time without any disadvantages
Who cannot join
- A patient with history of uncontrolled seizures, central nervous system disorder or psychiatric disorders that are considered clinically significant by the investigator that would prohibit the understanding of informed consent or that may be considered to interfere with the compliance of the administration of the study medications
- A patient with uncontrolled diabetes
- A patient who developed uncontrolled serious infection or other uncontrolled serious concomitant diseases
- A patient with disease progression after run-in period who is expected to receive another chomotherapeutic agents with different level of emetic risk
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study of Methylprednisolone Replacement for Dexamethasone-induced Hiuup Patients
Dexamethasone is a potent synthetic member of the corticosteroid. It is given to cancer patients undergoing chemotherapy to counteract emetic side effect and essential drug for the chemotherapy-treated patients. Hiccup is common adverse effect of corticosteroid especially on dexamethasone varying from 3% to 60% of given patients. Discontinuance of dexamethasone relieves most hiccupping cases, but vomiting/nausea rates increase. It is not clear whether hiccup side effect is limited to the dexamethasone only or other corticosteroid group.
Methylprednisolone, synthetic corticosteroid as similar as dexamethasone, could be considered as antiemetic agent for the patients with receiving chemotherapy. The investigators perform this pilot study under hypothesis that replacing dexamethasone with methylprednisolone could maintain antiemetic role and prevent hiccup.
- Conditions
- Dexamethasone, Hiccup
- Being tested
- Methylprednisolone
- Medical subject headings
- Hiccup
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Run-in period: dexamethasone 10-20mg q day iv during chemotherapy Treatment period: methylprednisolone 60-125mg iv during chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Methylprednisolone replacement | Experimental | This study will enroll the patients who were previously experienced dexamethasone-induced hiccup. Patients who experienced dexamethasone-induced hiccup during chemotherapy will enroll to study arm.
Run-in period * Dexamethasone 10mg-20mg q day iv during chemotherapy
▶ measure hiccup and nausea/vomiting severity
Treatment period * Methylprednisolone 60mg-125mg iv during chemotherapy
▶ measure hiccup and nausea/vomiting severity
Response will be evaluated by Common Terminology Criteria for Adverse Events version 4.0 (CTCAE) and NRS to hiccup at 24hrs after start methylprednisolone.
Nausea and vomiting will be assessed as CTCAE 4.0 Receives: Drug: Methylprednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevention rate of dexamethasone induced hiccup
measure the presence of hiccup and its severity 24 hous after chemotherapy
Measured: 24hrs after chemotherapy
Secondary outcomes (1)
Prevention rate of nausea and vomiting
Prevention rate of nausea and vomiting 24 hours and 7 days after chemotherapy, respectively
Measured: acute; 24 hours, delayed; 7 days after chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2011 (estimated)
- Study startJul 2010
- Primary completionJul 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DexamethasoneStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gyeongsang National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jung Hun Kang, Gyeongsang National University Hospital
- Investigators
- Jung Hun Kang, M.D, Ph.D, Principal investigator, Gyeongsang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01277731
- Sponsor's protocol ID
- Gyeongsang-20100701
- Status last verified
- Nov 2012
- First submitted
- 13 Jan 2011
- Last updated
- 20 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Methylprednisolone Replacement for Dexamethasone-induced Hiuup Patients
- ClinicalTrials.gov ID
- NCT01277731
- Acronym / sponsor ID
- Gyeongsang-20100701
- Conditions
- Dexamethasone, Hiccup
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Gyeongsang National University HospitalUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Jul 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 17 Jan 2011 (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.
Dexamethasone is a potent synthetic member of the corticosteroid. It is given to cancer patients undergoing chemotherapy to counteract emetic side effect and essential drug for the chemotherapy-treated patients. Hiccup is common adverse effect of corticosteroid especially on dexamethasone varying from 3% to 60% of given patients. Discontinuance of dexamethasone relieves most hiccupping cases, but vomiting/nausea rates increase. It is not clear whether hiccup side effect is limited to the dexamethasone only or other corticosteroid group.
Methylprednisolone, synthetic corticosteroid as similar as dexamethasone, could be considered as antiemetic agent for the patients with receiving chemotherapy. The investigators perform this pilot study under hypothesis that replacing dexamethasone with methylprednisolone could maintain antiemetic role and prevent hiccup.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Methylprednisolone replacement | Experimental | Drug: MethylprednisoloneThis study will enroll the patients who were previously experienced dexamethasone-induced hiccup. Patients who experienced dexamethasone-induced hiccup during chemotherapy will enroll to study arm. Run-in period * Dexamethasone 10mg-20mg q day iv during chemotherapy ▶ measure hiccup and nausea/vomiting severity Treatment period * Methylprednisolone 60mg-125mg iv during chemotherapy ▶ measure hiccup and nausea/vomiting severity Response will be evaluated by Common Terminology Criteria for Adverse Events version 4.0 (CTCAE) and NRS to hiccup at 24hrs after start methylprednisolone. Nausea and vomiting will be assessed as CTCAE 4.0 |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age olderthan 21
- A Patient on chemotherapy who was diagnosed malignant tumor
- A Patient who is newly developed hiccup in the course of chemotherapy
- A patient with the willingness to comply with the study protocol during the study period and capable of ccomplying with it
- A patient who signed the imformed consent prior to the participation of the study and who understands that he/she has a right to withdrawal from participation in the study at any time without any disadvantages
Key exclusion criteria (4 listed)
- A patient with history of uncontrolled seizures, central nervous system disorder or psychiatric disorders that are considered clinically significant by the investigator that would prohibit the understanding of informed consent or that may be considered to interfere with the compliance of the administration of the study medications
- A patient with uncontrolled diabetes
- A patient who developed uncontrolled serious infection or other uncontrolled serious concomitant diseases
- A patient with disease progression after run-in period who is expected to receive another chomotherapeutic agents with different level of emetic risk
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 |
|---|---|---|
| MethylprednisoloneRun-in period: dexamethasone 10-20mg q day iv during chemotherapy Treatment period: methylprednisolone 60-125mg iv during chemotherapy | Drug | Methylprednisolone replacement |
Primary outcome
Prevention rate of dexamethasone induced hiccup
Time frame: 24hrs after chemotherapy
measure the presence of hiccup and its severity 24 hous after chemotherapy
1 secondary outcome
Prevention rate of nausea and vomiting
Time frame: acute; 24 hours, delayed; 7 days after chemotherapy
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2012.
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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.
Jung Hun Kang, M.D, Ph.D principal investigator
Gyeongsang University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Methylprednisolone in people with Dexamethasone and Hiccup, run by Gyeongsang National University Hospital 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 5 inclusion and 4 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: withdrawn, as of the sponsor's last update on 20 Nov 2012. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Prevention rate of dexamethasone induced hiccup (time frame: 24hrs after chemotherapy). 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 20 Nov 2012.