Back to resultsReduced Dose of Prophylactic Dexamethasone for Elderly Patients Receiving Moderate Emetogenic Chemotherapy
Primary Purpose
Colonic Neoplasms
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Dexamethasone
Sponsored by
About this trial
This is an interventional supportive care trial for Colonic Neoplasms
Eligibility Criteria
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
Sites / Locations
- Seoul National University Bundang Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Elderly patients (>= 70 years of age)
Arm Description
Dexamethasone 8mg intravenously before chemotherapy
Outcomes
Primary Outcome Measures
Complete response (CR)
No emetic episode, no rescue medicine
Secondary Outcome Measures
Complete control (CC)
complete response with no more than mild nausea
Complete protection (CP)
complete response with no nausea
Full Information
NCT ID
NCT03177317
First Posted
June 4, 2017
Last Updated
December 1, 2020
Sponsor
Seoul National University Bundang Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03177317
Brief Title
Reduced Dose of Prophylactic Dexamethasone for Elderly Patients Receiving Moderate Emetogenic Chemotherapy
Official Title
A Feasibility Study of Reduced Dose of Prophylactic Dexamethasone for Elderly Patients Receiving Moderate Emetogenic Chemotherapies
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
January 1, 2020 (Actual)
Study Completion Date
January 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Neoplasms
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Elderly patients (>= 70 years of age)
Arm Type
Experimental
Arm Description
Dexamethasone 8mg intravenously before chemotherapy
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
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.
Primary Outcome Measure Information:
Title
Complete response (CR)
Description
No emetic episode, no rescue medicine
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Complete control (CC)
Description
complete response with no more than mild nausea
Time Frame
2 weeks
Title
Complete protection (CP)
Description
complete response with no nausea
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin Won Kim, M.D., PhD
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyeonggi
ZIP/Postal Code
13620
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Reduced Dose of Prophylactic Dexamethasone for Elderly Patients Receiving Moderate Emetogenic Chemotherapy
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