Dexamethasone-induced Hiccup in Chemotherapy Patients Treated by Methylprednisolone Rotation

Study Overview
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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.

Official Title
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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

Conditions
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Dexamethasone-induced Hiccup in Chemotherapy

Intervention / Treatment
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* Drug: methylprednisolone


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Methylprednisolone<br>Dexamethasone was replaced with methylprednisolone as an antiemetic. | Drug: methylprednisolone<br>* 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).<br>* Other names: solu-medrol;|
| Active Comparator: Dexamethasone<br>Dexamethasone was re-administered in the cycle. | Drug: methylprednisolone<br>* 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).<br>* Other names: solu-medrol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The intensities of hiccups | Clinically assessed every cycles(2-4weeks). The intensities of hiccups were assessed using a NRS. | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The intensities of emesis | CLinically assessed every cycles (2-4weeks) The intensities of emesis were assessed using a NRS. | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dexamethasone, Hiccup, Chemotherapy, Methylprednisolone