Methylprednisolone Replacement for Dexamethasone-induced Hiccup

NCT01277731 | Withdrawn

• 1 other identifier: Gyeongsang-20100701
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dexamethasone; Hiccup

Outcome Measures

Primary Outcomes (1)

• Prevention rate of dexamethasone induced hiccup

  measure the presence of hiccup and its severity 24 hous after chemotherapy

  24hrs after chemotherapy

Secondary Outcomes (1)

• Prevention rate of nausea and vomiting

  acute; 24 hours, delayed; 7 days after chemotherapy

Study Arms (1)

Methylprednisolone replacement

EXPERIMENTAL

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

Interventions

Methylprednisolone DRUG

Run-in period: dexamethasone 10-20mg q day iv during chemotherapy Treatment period: methylprednisolone 60-125mg iv during chemotherapy

Methylprednisolone replacement

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gyeongsang National University Hospital: lead

Study Sites (1)

Gyeongsang University Hospital

Jinju, South Korea

Location

MeSH Terms

Conditions

Hiccup

Interventions

Methylprednisolone

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Jung Hun Kang, M.D, Ph.D

  Gyeongsang University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 13, 2011
• First Posted: January 17, 2011
• Study Start: July 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: December 1, 2011
• Last Updated: November 20, 2012

Record last verified: 2012-11

Locations

KR (1)