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.

Abstract

Background: To assess whether the rotation of dexamethasone to methylprednisolone decreases the intensity of dexamethasone-induced hiccup (DIH) in cancer patients treated with chemotherapy.

Materials and methods: 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 (n = 33) or methylprednisolone (n = 32) 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). The primary endpoint was the difference in hiccup intensity as measured using the numeric rating scale (NRS) between two groups.

Results: No female patients were enrolled, although the study did not exclude them. At the randomization phase, hiccup frequency was 28/33 (84.8%) in the dexamethasone group versus 20/32 (62.5%) in the methylprednisolone group (p = .04). Intensity of hiccup was significantly higher in the dexamethasone group than that in the methylprednisolone group (mean NRS, 3.5 vs. 1.4, p < .001). At the crossover phase, hiccup intensity was further decreased after the rotation of dexamethasone to methylprednisolone in the dexamethasone group (mean NRS, 3.5 to 0.9, p < .001), while it was increased by rotating methylprednisolone to dexamethasone in the methylprednisolone group (mean NRS, 1.4 to 3.3, p = .025). There were no differences in emesis intensity between the two groups at either the randomization or crossover phases. Clinicaltrials.gov identifier: NCT01974024.

Conclusion: Dexamethasone-induced hiccup is a male-predominant phenomenon that can be ameliorated by rotating dexamethasone to methylprednisolone without compromising the antiemetic efficacy.

Implications for practice: In this randomized, multicenter, phase III trial, hiccup intensity was significantly lower when the antiemetic corticosteroid was rotated from dexamethasone to methylprednisolone without a change in emesis intensity than that when dexamethasone was maintained. At the crossover phase, hiccup intensity was increased again if dexamethasone was readministered instead of methylprednisolone. The present study demonstrated that dexamethasone-induced hiccup can be improved by rotating from dexamethasone to methylprednisolone without compromising its antiemetic efficacy.

摘要

背景.在接受化疗的癌症患者中评估将地塞米松更换为甲泼尼龙是否可以降低地塞米松诱发的呃逆(DIH)的强度。

材料与方法.筛选了接受地塞米松(止吐药)后3天内发生DIH的成年患者。入选患者被随机分配接受止吐药地塞米松(n = 33)或甲泼尼龙(n = 32)(随机化阶段)。在下一个化疗周期中, 地塞米松组接受了甲泼尼龙给药, 而甲泼尼龙组接受了地塞米松给药(交叉治疗阶段)。主要终点是使用数字评定量表(NRS)测定的两组间呃逆强度的差异。

结果.尽管这项研究并未将女性排除在外, 但也没有入组女性患者。在随机化阶段, 地塞米松组的呃逆发生率为28/33(84.8%), 甲泼尼龙组为20/32(62.5%)(p=0.04)。地塞米松组的呃逆强度明显高于甲泼尼龙组(两组的平均NRS分别为3.5和1.4, p<0.001)。在交叉治疗阶段, 将地塞米松组的地塞米松更换为甲泼尼龙后, 呃逆强度进一步降低(平均NRS为3.5至0.9, p<0.001), 将甲泼尼龙组中的甲泼尼龙更换为地塞米松后呃逆强度增加(平均NRS为1.4至3.3, p=0.025)。随机分组或交叉治疗阶段两组间的呕吐强度均无差异。Clinicaltrials.gov编号:NCT01974024

结论.地塞米松诱发的呃逆主要见于男性, 但该症状可以通过将地塞米松更换为甲泼尼龙得到改善, 而不会影响止吐效果。

Keywords: Cancer chemotherapy; Dexamethasone; Emesis; Hiccup; Methylprednisolone.

Publication types

  • Clinical Trial, Phase III
  • Randomized Controlled Trial

MeSH terms

  • Adrenal Cortex Hormones / administration & dosage*
  • Adrenal Cortex Hormones / adverse effects
  • Adult
  • Aged
  • Aged, 80 and over
  • Antiemetics / administration & dosage
  • Antiemetics / adverse effects
  • Dexamethasone / administration & dosage*
  • Dexamethasone / adverse effects
  • Drug-Related Side Effects and Adverse Reactions / classification
  • Drug-Related Side Effects and Adverse Reactions / drug therapy
  • Drug-Related Side Effects and Adverse Reactions / pathology
  • Hiccup / chemically induced
  • Hiccup / prevention & control
  • Humans
  • Male
  • Methylprednisolone / administration & dosage*
  • Methylprednisolone / adverse effects
  • Middle Aged
  • Neoplasms / complications
  • Neoplasms / drug therapy*
  • Vomiting / drug therapy
  • Vomiting / pathology

Substances

  • Adrenal Cortex Hormones
  • Antiemetics
  • Dexamethasone
  • Methylprednisolone

Associated data

  • ClinicalTrials.gov/NCT01974024