Shorter steroid regimen may prevent chemo allergies just as well
NCT ID NCT03598426
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested three ways of giving the steroid dexamethasone to prevent allergic reactions from the chemotherapy drug paclitaxel in 90 women with breast or gynecologic cancer. One group took oral dexamethasone the night before and morning of treatment, another got it intravenously just before chemo, and a third got both. The goal was to see if the shorter IV-only method works as well as the standard longer oral course, which could make pre-treatment easier for patients.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Dexamethasone (a steroid drug)
- What this could lead to
- If it works, this could show that a simpler, shorter IV steroid regimen is just as good as the standard longer oral course for preventing allergic reactions to paclitaxel.
- What could go wrong
- This is a small, single-center study with only 90 patients, so results may not apply to everyone. Also, it compares different ways of giving the same drug, so no new treatment is being discovered.
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 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
90 people
The number who actually took part.
- Started
-
Aug 2018
- Finished
-
Jan 2025
- 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
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Female participants only
- 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 Hide 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: 1. Adult female patients \> 18 years of age 2. Patients of the Loma Linda University Health (LLUH) gynecologic oncology and breast oncology service 3. Confirmed breast or gynecologic cancer diagnosis of any stage and any gynecologic or breast malignancy 4. Planned treatment with paclitaxel containing regimen either in the adjuvant setting or for palliation 5. Planned treatment with paclitaxel should be for 3 or more cycles given as a weekly or every 3 weeks cycle 6. Paclitaxel should be given as a monotherapy or as part of a combination regimen. If paclitaxel is part of a regimen containing other drugs, the following conditions must be met: 1. Paclitaxel will be the first chemotherapy regimen to be infused when patient comes in for treatment 2. Chemotherapy regimen that would be approved for the study are the following: i. Paclitaxel/ Carboplatin ii. Paclitaxel/Carboplatin/Bevacizumab iii. Paclitaxel/Cisplatin/Bevacizumab iv. Paclitaxel/Bevacizumab v. Paclitaxel/ Ifosfamide vi. Paclitaxel/ Pazopanib 7. Patients should have no prior exposure to taxanes (this includes: paclitaxel, docetaxel, and protein-bound paclitaxel) 8. The chemotherapy treatment should be at one of the LLUH Adult Cancer Centers 9. The patient should be an English or Spanish speaking patient Exclusion Criteria: 1. Patients who are not with the gynecologic or breast oncology service 2. Patients who are with the gynecologic oncology or breast oncology service but are not receiving paclitaxel either as a monotherapy or in combination with other regimen 3. Patients who have had prior exposure to taxanes (this includes: paclitaxel, docetaxel, and protein-bound paclitaxel) 4. Patients who are currently on steroid therapy and it is anticipated that therapy will not be discontinued at least a week prior to start of chemotherapy 5. Patients with autoimmune diseases, malignancies, and any other co-morbid condition that might require steroid therapy during chemotherapy. This includes, but not limited to: 1. Crohn's disease 2. Immune thrombocytopenia 3. Lupus nephritis 4. Multiple sclerosis 5. Primary brain tumors 6. Multiple Myeloma 7. Hodgkin's Lymphoma 6. Patients with uncontrolled diabetes or diabetic or pre-diabetic patients with baseline A1C levels \> 8.5 7. Patients who are allergic to diphenhydramine and/or dexamethasone 8. Non-English and Non-Spanish speaking patients
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Loma Linda University Cancer Center
Loma Linda, California, 92354, United States
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