Dexamethasone-induced Hiccup in Chemotherapy Patients Treated by Methylprednisolone Rotation

NCT ID: NCT01974024

Last Updated: 2017-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-01

Study Completion Date

2016-07-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Dexamethasone-induced Hiccup in Chemotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Methylprednisolone

Dexamethasone was replaced with methylprednisolone as an antiemetic.

Group Type EXPERIMENTAL

methylprednisolone

Intervention Type DRUG

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).

Dexamethasone

Dexamethasone was re-administered in the cycle.

Group Type ACTIVE_COMPARATOR

methylprednisolone

Intervention Type DRUG

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).

Interventions

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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).

Intervention Type DRUG

Other Intervention Names

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solu-medrol

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gyeongsang National University Hospital

OTHER

Sponsor Role collaborator

Dong-A University Hospital

OTHER

Sponsor Role collaborator

Samsung Medical Center

OTHER

Sponsor Role collaborator

Chung-Ang University

OTHER

Sponsor Role lead

Responsible Party

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In Gyu Hwang

In Gyu Hwang/Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jung Hun Kang, M.D.

Role: STUDY_CHAIR

Gyeongsang National University Hospital

Locations

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Gyeongsang National University Hospital

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

Site Status

Chungang University Hospital

Dongjak-gu, Seoul, South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 28687626 (View on PubMed)

Other Identifiers

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GSNUH 2013-1

Identifier Type: -

Identifier Source: org_study_id

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