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NCT03177317 Clinical Trial

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

Colonic Neoplasms Clinical Trial

Official title:
A Feasibility Study of Reduced Dose of Prophylactic Dexamethasone for Elderly Patients Receiving Moderate Emetogenic Chemotherapies

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03177317
Other study ID # B-1701-379-002
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2017
Est. completion date January 1, 2020

Study information
Verified date December 2020
Source Seoul National University Bundang Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date January 1, 2020
Est. primary completion date January 1, 2020
Accepts healthy volunteers No
Gender All
Age group 70 Years and older
Eligibility 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 Exclusion Criteria: - Having contraindication to dexamethasone - Having nausea or vomiting before the start of adjuvant chemotherapy

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Dexamethasone
Dexamethasone 8mg IV before chemotherapy on cycle 1 day 1 Once the complete response is achieved, the dose of dexamethasone will be reduced by 2 mg in the next cycle.

Locations
Country Name City State
Korea, Republic of Seoul National University Bundang Hospital Seongnam Gyeonggi

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Complete response (CR) No emetic episode, no rescue medicine 2 weeks
Secondary Complete control (CC) complete response with no more than mild nausea 2 weeks
Secondary Complete protection (CP) complete response with no nausea 2 weeks
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