Methylprednisolone Replacement for Dexamethasone-induced Hiccup

Pilot Study of Methylprednisolone Replacement for Dexamethasone-induced Hiuup Patients

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.

Study Overview

• Status: Withdrawn
• Conditions: Hiccup; Dexamethasone
• Intervention / Treatment: Drug: Methylprednisolone

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jinju, Korea, Republic of
    • Gyeongsang University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevention rate of dexamethasone induced hiccup	measure the presence of hiccup and its severity 24 hous after chemotherapy	24hrs after chemotherapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevention rate of nausea and vomiting	Prevention rate of nausea and vomiting 24 hours and 7 days after chemotherapy, respectively	acute; 24 hours, delayed; 7 days after chemotherapy

Collaborators and Investigators

• Sponsor: Gyeongsang National University Hospital
• Investigators: Principal Investigator: Jung Hun Kang, M.D, Ph.D, Gyeongsang University Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Anticipated): July 1, 2011
• Study Completion (Anticipated): December 1, 2011

Study Registration Dates

• First Submitted: January 13, 2011
• First Submitted That Met QC Criteria: January 14, 2011
• First Posted (Estimate): January 17, 2011

Study Record Updates

• Last Update Posted (Estimate): November 20, 2012
• Last Update Submitted That Met QC Criteria: November 18, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Hiccup; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Neuroprotective Agents; Protective Agents; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
• Other Study ID Numbers: Gyeongsang-20100701

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