Reduced Dose of Prophylactic Dexamethasone for Elderly Patients Receiving Moderate Emetogenic Chemotherapy

Not Applicable

Completed

• Conditions: Colonic Neoplasms
• Interventions: Drug: Dexamethasone

• Registration Number: NCT03177317
• Lead Sponsor: Seoul National University Bundang Hospital

Brief Summary

Feasibility study to evaluate the efficacy of reduced prophylactic dose of dexamethasone in elderly patients receiving moderate emetogenic chemotherapy

Detailed Description

The purpose of this trial is to determine if the dose of dexamethasone used as an antiemetic drug in patients with advanced cancer could be safely reduced.

Study Timeline

• Study Start: 2017-05-01
• Study First Submitted: 2017-06-04
• Study First Submitted QC: 2017-06-04
• Study First Posted: 2017-06-06
• Primary Completion: 2020-01-01
• Study Completion: 2020-01-01
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-01
• Last Update Posted: 2020-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Histopathologically confirmed colorectal cancer patients with curative resection
• ECOG performance status 0-2
• Provision of signed, written and dated informed consent prior to any study specific procedures
• Receiving adjuvant chemotherapy with FOLFOX (5-FU, leucovorin, oxaliplatin) regimen

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Exclusion Criteria

• Having contraindication to dexamethasone
• Having nausea or vomiting before the start of adjuvant chemotherapy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Elderly patients (>= 70 years of age)	Dexamethasone	Dexamethasone 8mg intravenously before chemotherapy

Primary Outcome Measures

Name	Time	Method
Complete response (CR)	2 weeks	No emetic episode, no rescue medicine

Secondary Outcome Measures

Name	Time	Method
Complete control (CC)	2 weeks	complete response with no more than mild nausea
Complete protection (CP)	2 weeks	complete response with no nausea

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Gyeonggi, Korea, Republic of