Methylprednisolone Replacement for Dexamethasone-induced Hiccup

Dexamethasone Clinical Trial

Official title:

Pilot Study of Methylprednisolone Replacement for Dexamethasone-induced Hiuup Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01277731
• Other study ID #: Gyeongsang-20100701
• Status: Withdrawn
• Phase: N/A
• First received: January 13, 2011
• Last updated: November 18, 2012
• Start date: July 2010
• Est. completion date: December 2011

Study information

• Verified date: November 2012
• Source: Gyeongsang National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 70 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dexamethasone
• Hiccup

Intervention

Drug:
• Methylprednisolone
Run-in period: dexamethasone 10-20mg q day iv during chemotherapy Treatment period: methylprednisolone 60-125mg iv during chemotherapy

Locations

Country	Name	City	State
Korea, Republic of	Gyeongsang University Hospital	Jinju

Sponsors (1)

Lead Sponsor	Collaborator
Gyeongsang National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevention rate of dexamethasone induced hiccup	measure the presence of hiccup and its severity 24 hous after chemotherapy	24hrs after chemotherapy	Yes
Secondary	Prevention rate of nausea and vomiting	Prevention rate of nausea and vomiting 24 hours and 7 days after chemotherapy, respectively	acute; 24 hours, delayed; 7 days after chemotherapy	Yes