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

Seoul National University

Status: Completed

Conditions: Colonic Neoplasms

Treatments: Drug: Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT03177317

B-1701-379-002

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 70+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Elderly patients (>= 70 years of age)

Experimental group

Description:

Dexamethasone 8mg intravenously before chemotherapy

Treatment:

Drug: Dexamethasone