Methylprednisolone Replacement for Dexamethasone-induced Hiccup

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Jung Hun Kang, Gyeongsang National University Hospital
ClinicalTrials.gov Identifier:
NCT01277731
First received: January 13, 2011
Last updated: November 18, 2012
Last verified: November 2012
  Purpose

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 Intervention
Dexamethasone
Hiccup
Drug: Methylprednisolone

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study of Methylprednisolone Replacement for Dexamethasone-induced Hiuup Patients

Resource links provided by NLM:


Further study details as provided by Gyeongsang National University Hospital:

Primary Outcome Measures:
  • Prevention rate of dexamethasone induced hiccup [ Time Frame: 24hrs after chemotherapy ] [ Designated as safety issue: Yes ]
    measure the presence of hiccup and its severity 24 hous after chemotherapy


Secondary Outcome Measures:
  • Prevention rate of nausea and vomiting [ Time Frame: acute; 24 hours, delayed; 7 days after chemotherapy ] [ Designated as safety issue: Yes ]
    Prevention rate of nausea and vomiting 24 hours and 7 days after chemotherapy, respectively


Enrollment: 0
Study Start Date: July 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01277731

Locations
Korea, Republic of
Gyeongsang University Hospital
Jinju, Korea, Republic of
Sponsors and Collaborators
Gyeongsang National University Hospital
Investigators
Principal Investigator: Jung Hun Kang, M.D, Ph.D Gyeongsang University Hospital
  More Information

No publications provided

Responsible Party: Jung Hun Kang, Associate Professor, Gyeongsang National University Hospital
ClinicalTrials.gov Identifier: NCT01277731     History of Changes
Other Study ID Numbers: Gyeongsang-20100701
Study First Received: January 13, 2011
Last Updated: November 18, 2012
Health Authority: South Korea: Institutional Review Board

Additional relevant MeSH terms:
Hiccup
Signs and Symptoms, Digestive
Signs and Symptoms
Dexamethasone acetate
Methylprednisolone acetate
Prednisolone acetate
Dexamethasone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Dexamethasone 21-phosphate
Prednisolone hemisuccinate
Prednisolone phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 31, 2014