efficacy of adding Aprepitant into antiemesis prophylactic regimen in nausea and vomiting of moderate emetogenic regime

Phase 3

• Conditions: Condition 1: nausea and vomiting. Condition 2: adverse reaction.; Nausea with vomiting, unspecified; Poisoning by, adverse effect of and underdosing of primarily systemic and hematological agents, not elsewhere classified; R11.2

• Registration Number: IRCT20191103045317N1
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 December 2019

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Cancer patients receiving moderate emetogenic chemotherapy regimens,formed the study cohort.
Eligible patients were adults (aged between 18 - 70 years) with a karnofsky index of 50% or more).
Women at reproductive ages should had undertaken an appropriate contraceptive method

Exclusion Criteria

causes of nausea or vomiting unrelated to the chemotherapy (e.g., gastrointestinal obstruction, massive ascites, widespread brain metastases, history of motion sickness or vestibular dysfunction, uremia or electrolyte disturbance)
active infection
uncontrolled seizure
candidate for radiation therapy of brain or upper abdomen in less than a week
an emetic episode 24 h before initiation of chemotherapy
complications that prohibited Dexamethasone use
one of the followings observed in their lab studies : wbc<3000/mm3 , anc<1500/m m3 , plt<100000 mm3, ALT & AST>2.5 * upper limit of normal,Bill & Cr > 1.5* upper limit of normal
opium addicted
poor compliance
receiving corticosteroids for more than 3 months and more than 50 mg Prednisone daily;
Carlson’s comorbidity scale of 3 or more
Any drugs with antiemetic efficacy other than the study drugs wouldn’t been allowed before the study started, and were recorded on.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients experiencing nausea and vomiting with MSKCC questionnaire. Timepoint: day 1 and 5 of chemotherapy. Method of measurement: MSKCC nausea and vomiting questionnaire.

Secondary Outcome Measures

Name	Time	Method
Complete response. Timepoint: day 1 and day 5 of chemotherapy. Method of measurement: MSKCC nausea and vomiting questionnaire.;Complete control. Timepoint: day 1 and day 5 of chemotherapy. Method of measurement: MSKCC nausea and vomiting questionnaire.;Overall response. Timepoint: day 1 and day 5 of chemotherapy. Method of measurement: MSKCC nausea and vomiting questionnaire.;Resistance to treatment. Timepoint: day 1 and day 5 of chemotherapy. Method of measurement: MASCC nausea and vomiting questionnaire.