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Dexamethasone-induced Hiccup in Chemotherapy Patients Treated by Methylprednisolone Rotation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01974024
First Posted: November 1, 2013
Last Update Posted: April 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Gyeongsang National University Hospital
Dong-A University Hospital
Samsung Medical Center
Information provided by (Responsible Party):
In Gyu Hwang, Chung-Ang University
  Purpose
The aims of this study were to investigate the feasibility of methylprednisolone rotation as treatment of DIH.

Condition Intervention Phase
Dexamethasone-induced Hiccup in Chemotherapy Drug: methylprednisolone Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by In Gyu Hwang, Chung-Ang University:

Primary Outcome Measures:
  • The intensities of hiccups [ Time Frame: 2 months ]
    Clinically assessed every cycles(2-4weeks). The intensities of hiccups were assessed using a NRS.


Secondary Outcome Measures:
  • The intensities of emesis [ Time Frame: 2 months ]
    CLinically assessed every cycles (2-4weeks) The intensities of emesis were assessed using a NRS.


Enrollment: 65
Actual Study Start Date: October 1, 2013
Study Completion Date: July 31, 2016
Primary Completion Date: June 30, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: solu-medrol

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.
  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01974024


Locations
Korea, Republic of
Gyeongsang National University Hospital
Chiram-dong, Jinju-si, Gyeongsangnam-do, Korea, Republic of, 660-702
Chungang University Hospital
Dongjak-gu, Seoul, Korea, Republic of, 156-755
Sponsors and Collaborators
Chung-Ang University
Gyeongsang National University Hospital
Dong-A University Hospital
Samsung Medical Center
Investigators
Study Chair: Jung Hun Kang, M.D. Gyeongsang National University Hospital
  More Information

Responsible Party: In Gyu Hwang, In Gyu Hwang/Associate Professor, Chung-Ang University
ClinicalTrials.gov Identifier: NCT01974024     History of Changes
Other Study ID Numbers: GSNUH 2013-1
First Submitted: October 28, 2013
First Posted: November 1, 2013
Last Update Posted: April 28, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Keywords provided by In Gyu Hwang, Chung-Ang University:
Dexamethasone
Hiccup
Chemotherapy
Methylprednisolone

Additional relevant MeSH terms:
Hiccup
Signs and Symptoms, Digestive
Signs and Symptoms
Dexamethasone acetate
Prednisolone acetate
Methylprednisolone acetate
Dexamethasone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Antiemetics
Prednisolone hemisuccinate
Prednisolone phosphate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Protective Agents