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Could less steroid before chemo be safer and just as effective?

NCT ID NCT02776436

Symptom relief Sponsor: Leiden University Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether giving a lower dose of the steroid dexamethasone before the chemotherapy drug docetaxel can prevent allergic reactions with fewer side effects. The standard high dose can cause problems like high blood sugar, mood changes, and weakened immunity. Researchers tested different lower doses in 46 people with breast or prostate cancer to find a safer option that still works.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

46 people

The number who actually took part.

Started

Jan 2016

Finished

Nov 2020

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer Prostate cancer

Contacts and locations

Locations

  • Haga hospital

    The Hague, Netherlands

  • Leiden university medical center

    Leiden, Netherlands

  • Reinier de Graaf hospital

    Delft, Netherlands

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