Reducing Dexamethasone Around Docetaxel Infusion (REDEX)

February 12, 2026 updated by: J.R. Kroep, Leiden University Medical Center

Phase 1 Study to Evaluate the Safety of REducing the Prophylactic Dose of DEXamethasone Around Docetaxel Infusion in Patients With Early or Advanced Breast Cancer and Prostate Cancer

The manufacturer recommends two different regimens of prophylactic dexamethasone to prevent hypersensitivity and fluid retention reactions caused by docetaxel: a 3-day regime of dexamethasone 8mg twice a day starting the day before chemotherapy for breast cancer and for prostate cancer 3 times 8mg dexamethasone on the day of docetaxel infusion, given the concurrent use of prednisone 2dd5mg. There is little evidence that supports this high dose regimen used nowadays. There is need to re-evaluate this high dosage of dexamethasone for three main reasons. First, dexamethasone can give side effects such as manifestation of latent diabetes mellitus, immunosuppression, personality changes, irritability, euphoria, or mania and mood swings. Second, dexamethasone is an immune suppressor, which might inhibit chemotherapy-induced apoptosis and compromise the efficacy of chemotherapeutic agents. Third, dexamethasone is a CYP3A4 inducer, which might increase docetaxel clearance. This study aims to evaluate the feasibility of reducing prophylactic of dexamethasone around docetaxel infusion.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Delft, Netherlands
        • Reinier de Graaf Hospital
      • Leiden, Netherlands
        • Leiden University Medical Center
      • The Hague, Netherlands
        • Haga hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with early breast cancer, or advanced breast cancer or prostate cancer patients receiving docetaxel (minimal 3 cycles monotherapy or in the regimen 4xAC > 4xdocetaxel or 3xFEC>3xdocetaxel or 6xTAC)
  • Age ≥18 years
  • WHO performance status 0-2
  • Adequate bone marrow function: white blood cells (WBCs) ≥3.0 x 109/l, neutrophils ≥1.5 x 109/l, platelets ≥100 x 109/l
  • Adequate liver function: bilirubin ≤1.5 x upper limit of normal (UNL) range, ALAT and/or ASAT ≤2.5 x UNL (<5 x UNL in case of liver metastases), Alkaline Phosphatase ≤5 x UNL
  • Adequate renal function: the calculated creatinine clearance should be ≥50 mL/min
  • Survival expectation must be > 3 months
  • Written informed consent according to the local Ethics Committee requirements

Exclusion Criteria:

  • Known hypersensitivity for docetaxel, paclitaxel or other chemotherapeutic agent or products containing polysorbate 80 or an earlier experience of anaphylaxis for food, insect bites, medication or another foreign substance.
  • Existence of edema of the limbs or trunk or elsewhere localized.
  • Active second malignancy
  • Diabetes Mellitus
  • Serious other diseases such as recent myocardial infarction (last 6 months), clinical signs of cardiac failure or clinically significant arrhythmias
  • Female patients who are pregnant or breast-feeding
  • Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Breast cancer

Dose of prophylactic dexamethasone will be reduced as follows:

STEP 1: 12 mg dexamethasone per day (8-4mg/day) for 3 days starting 1 day before administration. (n=6)

STEP 2: 8mg dexamethasone per day (8mg once a day) for 3 days starting 1 day before administration. (n=6)

STEP 3: day -1: 4 mg, day 0: 8 mg, day 1: 4 mg. (n=6)

STEP 4: day -1: 0 mg, day 0: 8 mg, day 1: 4 mg. (n=6)

STEP 5: day -1: 0 mg, day 0: 8 mg, day 1: 0 mg. (n=6)

STEP 6: day -1: 0 mg, day 0: 4 mg, day 1: 0 mg. (n=6)
Drug: Dexamethasone
Dose of prophylactic dexamethasone will be reduced for all patients
Other Names:
  • dexa
Experimental: Prostate cancer

Dose of prophylactic dexamethasone will be reduced as follows:

STEP 1: 2dd 8 mg at 12 and 1 hr before treatment (besides standard prednisone 5mg bid) (n=6)

STEP 2: 8mg dexamethasone 1 hour before treatment (and standard prednisone 5mg bid). (n=6)

STEP 3: 4mg dexamethasone 1 hour before treatment (and standard prednisone 5mg bid). (n=6)

STEP 4: 0mg dexamethasone (only standard prednisone 5mg bid). (n=6)
Drug: Dexamethasone
Dose of prophylactic dexamethasone will be reduced for all patients
Other Names:
  • dexa
Drug: Prednisone
standard prednisone 5 mg bid for patients with prostate cancer
Other Names:
  • prednison

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Optimal dose/recommended dose (RD) of pre-medication dexamethasone around docetaxel infusion, dependent of occurrence of grade III/IV fluid retention and HSR according to the NCI CTCAE v4.03.
Time Frame: up to 30 weeks
If one grade III/IV HSR or fluid retention reaction occurs in one of the six patients within one cohort, then three additional patients will be treated at that dose level. If there are no additional grade III/IV HSR or fluid retention in that additional 3 patients accrual to the next lower dose level will be started. If a grade III/IV HSR or fluid retention occurs in at least 2/6 or 2/9 patients, that dose will not be tolerated as safe and the last previous dose level of dexamethasone will be the RD.
up to 30 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Glucose (mmol/L) response due to prophylactic dexamethasone on day 0 before chemotherapy.
Time Frame: up to 30 weeks
up to 30 weeks
Insulin(mU/L), response due to prophylactic dexamethasone on day 0 before chemotherapy.
Time Frame: up to 30 weeks
up to 30 weeks
IGF-1(nmol/L) response due to prophylactic dexamethasone on day 0 before chemotherapy.
Time Frame: up to 30 weeks
up to 30 weeks
Number of participants with toxicity of chemotherapy according to NCI CTCAE v4.03 compared in each dose level of dexamethasone.
Time Frame: up to 30 weeks
up to 30 weeks
Patient's quality of life (descriptive).
Time Frame: up to 30 weeks
up to 30 weeks
Number of patients with single nucleotide polymorphisms in the glucocorticoid receptor.
Time Frame: one week
one week

Other Outcome Measures

Outcome Measure
Time Frame
The effect of dexamethasone on the Maximum concentration of docetaxel (Cmax)
Time Frame: 24 hours
24 hours
The effect of dexamethasone on Area under the plasma-time concentration curve (AUC) of docetaxel.
Time Frame: 24 hours
24 hours
The effect of dexamethasone on Elimination half-lives of docetaxel (T½,α; T½,β; T½,ƴ) of docetaxel.
Time Frame: 24 hours
24 hours
The effect of dexamethasone on Total body clearance of docetaxel (Cl) of docetaxel.
Time Frame: 24 hours
24 hours
The effect of dexamethasone on Volume of distribution of docetaxel at steady state (Vdss)
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Leiden University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

November 20, 2020

Study Completion (Actual)

November 20, 2020

Study Registration Dates

First Submitted

January 25, 2016

First Submitted That Met QC Criteria

May 17, 2016

First Posted (Estimated)

May 18, 2016

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 12, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • p15.157
  • 2015-000718-22 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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