Dexamethasone-induced Hiccup in ChemotherapyPhase 3NCT01974024
Dexamethasone-induced Hiccup in Chemotherapy Patients Treated by Methylprednisolone Rotation
A Phase 3 study testing methylprednisolone in people with Dexamethasone-induced Hiccup in Chemotherapy, run by Chung-Ang University at 2 sites in South Korea.
Trial summary
The aims of this study were to investigate the feasibility of methylprednisolone rotation as treatment of DIH. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dexamethasone-induced Hiccup in Chemotherapy
- What is being tested?
- methylprednisolone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 1 Oct 2013to 31 Jul 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all solid cancer patients on chemotherapy
- age >18 years
- received dexamethasone as an antiemetic
Who cannot join
- brain metastases
- hiccups before dexamethasone administration
- uncontrolled diabetes mellitus
- uncontrolled esophagitis or peptic ulcer
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Gyeongsang National University Hospital
Chiram-dong, Jinju-si, Gyeongsangnam-do, 660-702
Chungang University Hospital
Dongjak-gu, Seoul, 156-755
About this study
Official title: Antiemetic Corticosteroid Rotation From Dexamethasone to Methylprednisolone to Prevent Dexamethasone-Induced Hiccup in Cancer Patients Treated With Chemotherapy: A Randomized, Single-Blind, Crossover Phase III Trial
The aims of this study were to investigate the feasibility of methylprednisolone rotation as treatment of DIH.
Read the detailed description
we planned a randomized prospective trial for cancer patients with DIH. The objective of the present study was to determine whether the rotation of corticosteroids affects the incidence and intensity of DIH without compromising the antiemetic efficacy.
- Being tested
- methylprednisolone
- Keywords
- Dexamethasone, Hiccup, Chemotherapy, Methylprednisolone
- Medical subject headings
- Hiccup
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called solu-medrol
Adult patients who experienced DIH within 3 days after the administration of dexamethasone as an antiemetic were screened. Eligible patients were randomly assigned to receive dexamethasone or methylprednisolone as an antiemetic (randomization phase). In the next cycle of chemotherapy, the dexamethasone group received methylprednisolone and vice versa in the methylprednisolone group (crossover phase).
| Study group | Role | What they receive |
|---|---|---|
| Methylprednisolone | Experimental | Dexamethasone was replaced with methylprednisolone as an antiemetic. Receives: Drug: methylprednisolone |
| Dexamethasone | Active comparator | Dexamethasone was re-administered in the cycle. Receives: Drug: methylprednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The intensities of hiccups
Clinically assessed every cycles(2-4weeks). The intensities of hiccups were assessed using a NRS.
Measured: 2 months
Secondary outcomes (1)
The intensities of emesis
CLinically assessed every cycles (2-4weeks) The intensities of emesis were assessed using a NRS.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2013 (estimated)
- Study start1 Oct 2013
- Primary completion30 Jun 2016
- Study completion31 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dexamethasone-induced Hiccup in ChemotherapyStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chung-Ang University
- Sponsor type
- University, hospital or other
- Collaborators
- Gyeongsang National University Hospital, Dong-A University Hospital, Samsung Medical Center
- Responsible party
- Principal investigator, In Gyu Hwang, Chung-Ang University
- Investigators
- Jung Hun Kang, M.D., Study chair, Gyeongsang National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01974024
- Sponsor's protocol ID
- GSNUH 2013-1
- Status last verified
- Apr 2017
- First submitted
- 28 Oct 2013
- Last updated
- 28 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Go SI, Koo DH, Kim ST, Song HN, Kim RB, Jang JS, Oh SY, Lee KH, Lee SI, Kim SG, Park LC, Lee SC, Park BB, Ji JH, Yi SY, Lee YG, Yun J, Bruera E, Hwang IG, Kang JH. Antiemetic Corticosteroid Rotation from Dexamethasone to Methylprednisolone to Prevent Dexamethasone-Induced Hiccup in Cancer Patients Treated with Chemotherapy: A Randomized, Single-Blind, Crossover Phase III Trial. Oncologist. 2017 Nov;22(11):1354-1361. doi: 10.1634/theoncologist.2017-0129. Epub 2017 Jul 7.
PubMed 28687626
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antiemetic Corticosteroid Rotation From Dexamethasone to Methylprednisolone to Prevent Dexamethasone-Induced Hiccup in Cancer Patients Treated With Chemotherapy: A Randomized, Single-Blind, Crossover Phase III Trial
- ClinicalTrials.gov ID
- NCT01974024
- Acronym / sponsor ID
- GSNUH 2013-1
- Keywords
- Dexamethasone, Hiccup, Chemotherapy, Methylprednisolone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Chung-Ang UniversityUniversity, hospital or other
- Collaborators
- Gyeongsang National University Hospital, Dong-A University Hospital, Samsung Medical Center
- Study start
- 1 Oct 2013 (actual)
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- 31 Jul 2016 (actual)
- First posted
- 1 Nov 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.
The aims of this study were to investigate the feasibility of methylprednisolone rotation as treatment of DIH.
Detailed description
we planned a randomized prospective trial for cancer patients with DIH. The objective of the present study was to determine whether the rotation of corticosteroids affects the incidence and intensity of DIH without compromising the antiemetic efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methylprednisolone | Experimental | Drug: methylprednisoloneDexamethasone was replaced with methylprednisolone as an antiemetic. |
| Dexamethasone | Active comparator | Drug: methylprednisoloneDexamethasone was re-administered in the cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- all solid cancer patients on chemotherapy
- age >18 years
- received dexamethasone as an antiemetic
Key exclusion criteria (4 listed)
- brain metastases
- hiccups before dexamethasone administration
- uncontrolled diabetes mellitus
- uncontrolled esophagitis or peptic ulcer
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 |
|---|---|---|
| methylprednisoloneAlso: solu-medrolAdult patients who experienced DIH within 3 days after the administration of dexamethasone as an antiemetic were screened. Eligible patients were randomly assigned to receive dexamethasone or methylprednisolone as an antiemetic (randomization phase). In the next cycle of chemotherapy, the dexamethasone group received methylprednisolone and vice versa in the methylprednisolone group (crossover phase). | Drug | Dexamethasone, Methylprednisolone |
Primary outcome
The intensities of hiccups
Time frame: 2 months
Clinically assessed every cycles(2-4weeks). The intensities of hiccups were assessed using a NRS.
1 secondary outcome
The intensities of emesis
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2017.
- Derived from this study: PubMed 28687626Go SI, Koo DH, Kim ST, Song HN, Kim RB, Jang JS, Oh SY, Lee KH, Lee SI, Kim SG, Park LC, Lee SC, Park BB, Ji JH, Yi SY, Lee YG, Yun J, Bruera E, Hwang IG, Kang JH. Antiemetic Corticosteroid Rotation from Dexamethasone to Methylprednisolone to Prevent Dexamethasone-Induced Hiccup in Cancer Patients Treated with Chemotherapy: A Randomized, Single-Blind, Crossover Phase III Trial. Oncologist. 2017 Nov;22(11):1354-1361. doi: 10.1634/theoncologist.2017-0129. Epub 2017 Jul 7.
- Individual participant dataSharing planned: Undecided
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. study chair
Gyeongsang National University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing methylprednisolone in people with Dexamethasone-induced Hiccup in Chemotherapy, run by Chung-Ang University at 2 sites 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 3 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: finished, as of the sponsor's last update on 28 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The intensities of hiccups (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01974024, which also lists 1 linked publication.
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 28 Apr 2017.