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Dexamethasone-induced Hiccup in Chemotherapy Patients Treated by Methylprednisolone Rotation

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01974024
Enrollment
65
Registered
2013-11-01
Start date
2013-10-01
Completion date
2016-07-31
Last updated
2017-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dexamethasone-induced Hiccup in Chemotherapy

Keywords

Dexamethasone, Hiccup, Chemotherapy, Methylprednisolone

Brief summary

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

Detailed 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.

Interventions

DRUGmethylprednisolone

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).

Sponsors

Gyeongsang National University Hospital
CollaboratorOTHER
Dong-A University Hospital
CollaboratorOTHER
Samsung Medical Center
CollaboratorOTHER
Chung-Ang University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The intensities of hiccups2 monthsClinically assessed every cycles(2-4weeks). The intensities of hiccups were assessed using a NRS.

Secondary

MeasureTime frameDescription
The intensities of emesis2 monthsCLinically assessed every cycles (2-4weeks) The intensities of emesis were assessed using a NRS.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026