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Randomize Controlled Phase 3, Cross-over Trial of Dexamethasone-induced Hiccup in Chemotherapy Patients Treated by Methylprednisolone Rotation

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2013 by Chung-Ang University.
Recruitment status was:  Not yet recruiting
Gyeongsang National University Hospital
Dong-A University Hospital
Samsung Medical Center
Information provided by (Responsible Party):
In Gyu Hwang, Chung-Ang University Identifier:
First received: October 28, 2013
Last updated: October 31, 2013
Last verified: October 2013
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: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by 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.

Estimated Enrollment: 140
Study Start Date: December 2013
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Methylprednisolone
Dexamethasone was replaced with methylprednisolone as an antiemetic
Drug: methylprednisolone
Active Comparator: Dexamethasone
Dexamethasone was re-administered in the cycle
Drug: methylprednisolone


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

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
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Please refer to this study by its identifier: NCT01974024

Contact: Jung Hun Kang, M.D. 82-10-9344-0543
Contact: In Gyu Hwang, M.D. 82-10-3566-9053

Korea, Republic of
Gyeongsang National University Hospital Active, not recruiting
Chiram-dong, Jinju-si, Gyeongsangnam-do, Korea, Republic of, 660-702
Chungang University Hospital Not yet recruiting
Dongjak-gu, Seoul, Korea, Republic of, 156-755
Contact: In Gyu Hwang, M.D.    +82-10-3566-9053   
Principal Investigator: In Gyu Hwang, M.D.         
Sponsors and Collaborators
Chung-Ang University
Gyeongsang National University Hospital
Dong-A University Hospital
Samsung Medical Center
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 Identifier: NCT01974024     History of Changes
Other Study ID Numbers: GSNUH 2013-1
Study First Received: October 28, 2013
Last Updated: October 31, 2013

Keywords provided by Chung-Ang University:

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms
Dexamethasone acetate
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Dexamethasone 21-phosphate
Prednisolone hemisuccinate
Prednisolone phosphate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Protective Agents processed this record on March 27, 2017