Methylprednisolone Replacement for Dexamethasone-induced Hiccup

Sponsor

Gyeongsang National University Hospital (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01277731

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Dexamethasone Hiccup	Drug: Methylprednisolone	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Pilot Study of Methylprednisolone Replacement for Dexamethasone-induced Hiuup Patients

Study Start Date :

Jul 1, 2010

Anticipated Primary Completion Date :

Jul 1, 2011

Anticipated Study Completion Date :

Dec 1, 2011

Arms and Interventions

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

Arm

Intervention/Treatment

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

Drug: Methylprednisolone

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

Outcome Measures

Primary Outcome Measures

Prevention rate of dexamethasone induced hiccup [24hrs after chemotherapy]
measure the presence of hiccup and its severity 24 hous after chemotherapy

Secondary Outcome Measures

Prevention rate of nausea and vomiting [acute; 24 hours, delayed; 7 days after chemotherapy]
Prevention rate of nausea and vomiting 24 hours and 7 days after chemotherapy, respectively

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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