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Completed

NCT Number: NCT03177317

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

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

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Key information

Conditions

Colonic Neoplasms Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone

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.

Primary outcomes

  1. Complete response (CR)

    Time frame: 2 weeks

    No emetic episode, no rescue medicine

Secondary outcomes

  1. Complete control (CC)

    Time frame: 2 weeks

    complete response with no more than mild nausea

  2. Complete protection (CP)

    Time frame: 2 weeks

    complete response with no nausea

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jun 6, 2017
Registry last updated
Dec 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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