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Methylprednisolone Replacement for Dexamethasone-induced Hiccup

NCT ID: NCT01277731

Last Updated: 2012-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Dexamethasone Hiccup

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Methylprednisolone

Intervention Type DRUG

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

Interventions

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Methylprednisolone

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gyeongsang National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jung Hun Kang

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jung Hun Kang, M.D, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Gyeongsang University Hospital

Locations

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Gyeongsang University Hospital

Jinju, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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Gyeongsang-20100701

Identifier Type: -

Identifier Source: org_study_id