Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00895245 · OUTCOME

Control of Nausea for 120 Hours Following Each Cisplatin Infusion for Multiple Cycles of Therapy as Measured by the Visual Analog Scale

Fosaprepitant Dimeglumine, Palonosetron Hydrochloride, and Dexamethasone in Preventing Nausea and Vomiting Caused by Cisplatin in Patients With Stage III or Stage IV Head and Neck Cancer Undergoing Chemotherapy and Radiation Therapy · Source last updated 2017-05-18

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEAN
Unit
millimeters
Interval / dispersion
Full Range
Time frame
120 hours following cisplatin infusion

What was measured

The visual analog scale ranges from 0-100. 0 is labeled as "no nausea" and 100 is labeled as "nausea as bad as it could be" A score of \< 25 is considered to indicate no significant nausea. All patients discontinued trial after only one cisplatin infusion.

Groups in this outcome

Arm I

Patients receive cisplatin IV on day 1. Treatment repeats every 21 days for up to 3 courses. Patients undergo radiotherapy once daily 5 days a week for up to 7 weeks. Patients receive fosaprepitant dimeglumine IV, palonosetron hydrochloride IV, and dexamethasone IV on day 1.Patients receive oral dexamethasone on days 2-4. Patients with no emesis or need for rescue anti-emetics in the first 120 hours after cisplatin infusion continue to receive the anti-emetic regimen as above with the second and third courses of cisplatin. Patients complete an emesis diary daily for 5 days after each cisplatin infusion. Patients also complete a Functional Living Index-Emesis Questionnaire on day 8 after each cisplatin infusion. fosaprepitant dimeglumine: Given IV cisplatin: Given IV palonosetron hydrochloride: Given IV dexamethasone: Given IV and orally Functional Living Index-Emesis Questionnaire: Ancillary studies Emesis Diary: Ancillary studies Radiotherapy: Undergo r

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Arm I6

Reported measurements

Source class 1
Values in millimeters · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Arm I45.2Not reported679Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6
        upper Limit
        79
        value
        45.2
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    units
    Participants
description
The visual analog scale ranges from 0-100. 0 is labeled as "no nausea" and 100 is labeled as "nausea as bad as it could be" A score of \< 25 is considered to indicate no significant nausea. All patients discontinued trial after only one cisplatin infusion.
dispersion Type
Full Range
groups
  1. description
    Patients receive cisplatin IV on day 1. Treatment repeats every 21 days for up to 3 courses. Patients undergo radiotherapy once daily 5 days a week for up to 7 weeks. Patients receive fosaprepitant dimeglumine IV, palonosetron hydrochloride IV, and dexamethasone IV on day 1.Patients receive oral dexamethasone on days 2-4. Patients with no emesis or need for rescue anti-emetics in the first 120 hours after cisplatin infusion continue to receive the anti-emetic regimen as above with the second and third courses of cisplatin. Patients complete an emesis diary daily for 5 days after each cisplatin infusion. Patients also complete a Functional Living Index-Emesis Questionnaire on day 8 after each cisplatin infusion. fosaprepitant dimeglumine: Given IV cisplatin: Given IV palonosetron hydrochloride: Given IV dexamethasone: Given IV and orally Functional Living Index-Emesis Questionnaire: Ancillary studies Emesis Diary: Ancillary studies Radiotherapy: Undergo r
    id
    OG000
    title
    Arm I
param Type
MEAN
reporting Status
POSTED
time Frame
120 hours following cisplatin infusion
title
Control of Nausea for 120 Hours Following Each Cisplatin Infusion for Multiple Cycles of Therapy as Measured by the Visual Analog Scale
type
SECONDARY
unit Of Measure
millimeters

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice