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Completed

NCT Number: NCT01974024

Dexamethasone-induced Hiccup in Chemotherapy Patients Treated by Methylprednisolone Rotation

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

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Key information

Conditions

Dexamethasone-induced Hiccup in Chemotherapy Hiccup Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Gyeongsang National University Hospital, Chiram-dong, Jinju-si, Gyeongsangnam-do, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

methylprednisolone

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).

Other names: solu-medrol

Primary outcomes

  1. The intensities of hiccups

    Time frame: 2 months

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

Secondary outcomes

  1. The intensities of emesis

    Time frame: 2 months

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

Sponsors and collaborators

Lead sponsor

Chung-Ang University

Other

Collaborators

  • Dong-A University Hospital
  • Gyeongsang National University Hospital
  • Samsung Medical Center

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Nov 1, 2013
Registry last updated
Apr 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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