NCT01974024

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2013

Typical duration for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

October 28, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 1, 2013

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2016

Completed
Last Updated

April 28, 2017

Status Verified

April 1, 2017

Enrollment Period

2.7 years

First QC Date

October 28, 2013

Last Update Submit

April 27, 2017

Conditions

Dexamethasone-induced Hiccup in Chemotherapy

Keywords

DexamethasoneHiccupChemotherapyMethylprednisolone

Outcome Measures

Primary Outcomes (1)

  • The intensities of hiccups

    Clinically assessed every cycles(2-4weeks). The intensities of hiccups were assessed using a NRS.

    2 months

Secondary Outcomes (1)

  • The intensities of emesis

    2 months

Study Arms (2)

Methylprednisolone

EXPERIMENTAL

Dexamethasone was replaced with methylprednisolone as an antiemetic.

Drug: methylprednisolone

Dexamethasone

ACTIVE COMPARATOR

Dexamethasone was re-administered in the cycle.

Drug: methylprednisolone

Interventions

methylprednisoloneDRUG

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).

Also known as: solu-medrol
DexamethasoneMethylprednisolone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • all solid cancer patients on chemotherapy
  • age \>18 years
  • received dexamethasone as an antiemetic

You may not qualify if:

  • brain metastases
  • hiccups before dexamethasone administration
  • uncontrolled diabetes mellitus
  • uncontrolled esophagitis or peptic ulcer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Gyeongsang National University Hospital

Chiram-dong, Jinju-si, Gyeongsangnam-do, 660-702, South Korea

Location

Chungang University Hospital

Dongjak-gu, Seoul, 156-755, South Korea

Location

Related Publications (1)

  • Go SI, Koo DH, Kim ST, Song HN, Kim RB, Jang JS, Oh SY, Lee KH, Lee SI, Kim SG, Park LC, Lee SC, Park BB, Ji JH, Yi SY, Lee YG, Yun J, Bruera E, Hwang IG, Kang JH. 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. Oncologist. 2017 Nov;22(11):1354-1361. doi: 10.1634/theoncologist.2017-0129. Epub 2017 Jul 7.

    PMID: 28687626DERIVED

MeSH Terms

Conditions

Hiccup

Interventions

MethylprednisoloneMethylprednisolone Hemisuccinate

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Jung Hun Kang, M.D.

    Gyeongsang National University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
In Gyu Hwang/Associate Professor

Study Record Dates

First Submitted

October 28, 2013

First Posted

November 1, 2013

Study Start

October 1, 2013

Primary Completion

June 30, 2016

Study Completion

July 31, 2016

Last Updated

April 28, 2017

Record last verified: 2017-04

Locations

KR(2)