Dexamethasone-induced Hiccup in Chemotherapy Patients Treated by Methylprednisolone Rotation

April 27, 2017 updated by: In Gyu Hwang, Chung-Ang University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

65

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeongsangnam-do
      • Chiram-dong, Jinju-si, Gyeongsangnam-do, Korea, Republic of, 660-702
        • GyeongSang National University Hospital
    • Seoul
      • Dongjak-gu, Seoul, Korea, Republic of, 156-755
        • Chungang University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • all solid cancer patients on chemotherapy
  • age >18 years
  • received dexamethasone as an antiemetic

Exclusion Criteria:

  • brain metastases
  • hiccups before dexamethasone administration
  • uncontrolled diabetes mellitus
  • uncontrolled esophagitis or peptic ulcer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Methylprednisolone
Dexamethasone was replaced with methylprednisolone as an antiemetic.
Drug: methylprednisolone
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).
Other Names:
  • solu-medrol
Active Comparator: Dexamethasone
Dexamethasone was re-administered in the cycle.
Drug: methylprednisolone
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).
Other Names:
  • solu-medrol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The intensities of hiccups
Time Frame: 2 months
Clinically assessed every cycles(2-4weeks). The intensities of hiccups were assessed using a NRS.
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The intensities of emesis
Time Frame: 2 months
CLinically assessed every cycles (2-4weeks) The intensities of emesis were assessed using a NRS.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chung-Ang University

Collaborators

Samsung Medical Center
Gyeongsang National University Hospital
Dong-A University Hospital

Investigators

  • Study Chair: Jung Hun Kang, M.D., GyeongSang National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2013

Primary Completion (Actual)

June 30, 2016

Study Completion (Actual)

July 31, 2016

Study Registration Dates

First Submitted

October 28, 2013

First Submitted That Met QC Criteria

October 31, 2013

First Posted (Estimate)

November 1, 2013

Study Record Updates

Last Update Posted (Actual)

April 28, 2017

Last Update Submitted That Met QC Criteria

April 27, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GSNUH 2013-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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