Endocrinological Changes Due to Pre-medications of Chemotherapy in Patients With Breast Cancer

NCT04350229 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2023-10-05

No results posted yet for this study

Summary

Treatment for patients with high-risk breast cancer diagnoses is based on chemotherapy drugs with side effects. Dexamethasone is a drug that is part of the arsenal of pre-chemotherapy medications to prevent adverse events resulting from treatment, however common endocrine pathological conditions resulting from high doses of this corticoid are clinically evident in these individuals. The aim of this study is to evaluate the omission of corticosteroid doses as a pre-medication in cancer treatment after the second week of treatment with taxane in a curative setting.

Conditions

Interventions

DRUG

Drug omission

Drug omission. In the experimental group, dexamethasone will be omitted from the second application of paclitaxel.

OTHER

Control group

No drug omission. In the control group, dexamethasone will not be omitted in the second application of paclitaxel.

Sponsors & Collaborators

  • Instituto do Cancer do Estado de São Paulo

    lead OTHER

Principal Investigators

  • Vanessa A Scontre, MD · Instituto do Cancer do Estado de São Paulo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-27
Primary Completion
2022-06-20
Completion
2022-06-20

Countries

  • Brazil

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04350229 on ClinicalTrials.gov