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

Sponsor

Seoul National University Bundang Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03177317

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Colonic Neoplasms	Drug: Dexamethasone	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

May 1, 2017

Actual Primary Completion Date :

Jan 1, 2020

Actual Study Completion Date :

Jan 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Elderly patients (>= 70 years of age) Dexamethasone 8mg intravenously before chemotherapy	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.

Arm

Intervention/Treatment

Experimental: Elderly patients (>= 70 years of age)

Dexamethasone 8mg intravenously before chemotherapy

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.

Outcome Measures

Primary Outcome Measures

Complete response (CR) [2 weeks]
No emetic episode, no rescue medicine

Secondary Outcome Measures

Complete control (CC) [2 weeks]
complete response with no more than mild nausea
Complete protection (CP) [2 weeks]
complete response with no nausea

Eligibility Criteria

Criteria

Ages Eligible for Study:

70 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Bundang Hospital	Seongnam	Gyeonggi	Korea, Republic of	13620

Sponsors and Collaborators

Seoul National University Bundang Hospital

Investigators

Principal Investigator: Jin Won Kim, M.D., PhD, Seoul National University Bundang Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jin Won Kim, Associate Professor, Seoul National University Bundang Hospital

ClinicalTrials.gov Identifier:

NCT03177317

Other Study ID Numbers:

B-1701-379-002

First Posted:

Jun 6, 2017

Last Update Posted:

Dec 2, 2020

Last Verified:

Dec 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Colonic Neoplasms

Dexamethasone

Study Results

No Results Posted as of Dec 2, 2020