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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03177317

Enrollment

Registered

2017-06-06

Start date

2017-05-01

Completion date

2020-01-01

Last updated

2020-12-02

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

Conditions

Colonic Neoplasms

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.

Interventions

DRUGDexamethasone

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

70 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Complete response (CR)	2 weeks	No emetic episode, no rescue medicine

Secondary

Measure	Time frame	Description
Complete control (CC)	2 weeks	complete response with no more than mild nausea
Complete protection (CP)	2 weeks	complete response with no nausea

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026