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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-01

Study Completion Date

2020-01-01

Brief Summary

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

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Detailed Description

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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.

Conditions

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Colonic Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Elderly patients (>= 70 years of age)

Dexamethasone 8mg intravenously before chemotherapy

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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