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Methylprednisolone Replacement for Dexamethasone-induced Hiccup

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ClinicalTrials.gov Identifier: NCT01277731
Recruitment Status : Withdrawn
First Posted : January 17, 2011
Last Update Posted : November 20, 2012
Sponsor:
Information provided by (Responsible Party):
Jung Hun Kang, Gyeongsang National University Hospital

January 13, 2011
January 17, 2011
November 20, 2012
July 2010
July 2011   (Final data collection date for primary outcome measure)
Prevention rate of dexamethasone induced hiccup [ Time Frame: 24hrs after chemotherapy ]
measure the presence of hiccup and its severity 24 hous after chemotherapy
Same as current
Complete list of historical versions of study NCT01277731 on ClinicalTrials.gov Archive Site
Prevention rate of nausea and vomiting [ Time Frame: acute; 24 hours, delayed; 7 days after chemotherapy ]
Prevention rate of nausea and vomiting 24 hours and 7 days after chemotherapy, respectively
Same as current
Not Provided
Not Provided
 
Methylprednisolone Replacement for Dexamethasone-induced Hiccup
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.

Not Provided
Interventional
Not Applicable
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Dexamethasone
  • Hiccup
Drug: Methylprednisolone
Run-in period: dexamethasone 10-20mg q day iv during chemotherapy Treatment period: methylprednisolone 60-125mg iv during chemotherapy
Experimental: Methylprednisolone replacement

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

Intervention: Drug: Methylprednisolone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
30
December 2011
July 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sexes Eligible for Study: All
21 Years to 70 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01277731
Gyeongsang-20100701
No
Not Provided
Not Provided
Jung Hun Kang, Gyeongsang National University Hospital
Gyeongsang National University Hospital
Not Provided
Principal Investigator: Jung Hun Kang, M.D, Ph.D Gyeongsang University Hospital
Gyeongsang National University Hospital
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP