Dexamethasone-induced Hiccup in Chemotherapy Patients Treated by Methylprednisolone Rotation

Dexamethasone-induced Hiccup in Chemotherapy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01974024
• Other study ID #: GSNUH 2013-1
• Status: Completed
• Phase: Phase 3
• First received: October 28, 2013
• Last updated: April 27, 2017
• Start date: October 1, 2013
• Est. completion date: July 31, 2016

Study information

• Verified date: April 2017
• Source: Chung-Ang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aims of this study were to investigate the feasibility of methylprednisolone rotation as treatment of DIH.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: July 31, 2016
• Est. primary completion date: June 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dexamethasone-induced Hiccup in Chemotherapy
• Hiccup

Intervention

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).

Locations

Country	Name	City	State
Korea, Republic of	Gyeongsang National University Hospital	Chiram-dong, Jinju-si	Gyeongsangnam-do
Korea, Republic of	Chungang University Hospital	Dongjak-gu	Seoul

Sponsors (4)

Lead Sponsor	Collaborator
Chung-Ang University	Dong-A University Hospital, Gyeongsang National University Hospital, Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The intensities of hiccups	Clinically assessed every cycles(2-4weeks). The intensities of hiccups were assessed using a NRS.	2 months
Secondary	The intensities of emesis	CLinically assessed every cycles (2-4weeks) The intensities of emesis were assessed using a NRS.	2 months