Dexamethasone-induced Hiccup in Chemotherapy Patients Treated by Methylprednisolone Rotation

Overview

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

Full Title of Study: “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”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Crossover Assignment
  • Primary Purpose: Treatment
  • Masking: Single (Participant)
• Study Primary Completion Date: June 30, 2016

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

• Drug: 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).

Arms, Groups and Cohorts

• Experimental: Methylprednisolone
  • Dexamethasone was replaced with methylprednisolone as an antiemetic.
• Active Comparator: Dexamethasone
  • Dexamethasone was re-administered in the cycle.

Clinical Trial Outcome Measures

Primary Measures

• The intensities of hiccups
  • Time Frame: 2 months
  • Clinically assessed every cycles(2-4weeks). The intensities of hiccups were assessed using a NRS.

Secondary Measures

• The intensities of emesis
  • Time Frame: 2 months
  • CLinically assessed every cycles (2-4weeks) The intensities of emesis were assessed using a NRS.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Chung-Ang University
• Collaborator
  • Gyeongsang National University Hospital
• Provider of Information About this Clinical Study
  • Principal Investigator: In Gyu Hwang, In Gyu Hwang/Associate Professor – Chung-Ang University
• Overall Official(s)
  • Jung Hun Kang, M.D., Study Chair, Gyeongsang National University Hospital