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

Comparison between the effect of Triplet Aprepitant/Dexamethasone/Ondansetron vs. doublet Dexamethasone/Ondansetron for prevention of moderately emetogenic chemotherapy: placebo-controlled double blind, randomised clinical trial of efficacy

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20191103045317N1
Enrollment
90
Registered
2019-11-30
Start date
2018-12-21
Completion date
Unknown
Last updated
2019-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Interventions

Intervention 1: Intervention group: Patients were treated with triple antiemetic therapy comprising oral administration of 125 mg Aprepitant and intravenous injection of 12 mg Dexamethasone, and 8mg O

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

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

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 : wbc2.5 * 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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMania Rajabzadeh Kheradmardi

Shahid Beheshti University of Medical Sciences

mania_008@yahoo.com00982÷77543634

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026