Conventional Prophylactic Oral Dexamethasone vs Short-course IV Dexamethasone in Paclitaxel Hypersensitivity

Phase

Condition

Allergy (Pediatric)

Allergy

Allergies & Asthma

Treatment

Dexamethasone

Clinical Study ID

NCT03598426

5180198

Ages > 18
Female

Study Summary

This study is a single center, prospective, randomized, open-label study aimed at determining the most effective means of preventing hypersensitivity reactions in gynecologic oncology patients receiving paclitaxel infusions. The study will therefore provide clinicians with the best ways of preventing paclitaxel hypersensitivity reactions in their patients during treatment. Subjects will be randomized using the block randomization method into one of these three commonly used treatment methods:(1) Conventional method: oral dexamethasone (20 mg), taking 12 hours and 6 hours prior to paclitaxel infusion and intravenous administration of histamine-1 (H1), and a histamine-2 (H2)receptor antagonists administered 30 minutes prior to paclitaxel infusion. (2) Short-course method: intravenous dexamethasone (20 mg), administered concurrently with H1 and H2 antagonists, 30 minutes prior to paclitaxel infusion. (3) Combined method: oral dexamethasone (20 mg), taking 12 hours prior to treatment in addition to intravenous dexamethasone (20 mg), H1 and H2 receptor antagonists administered 30 minutes prior to paclitaxel infusion. The one-way analysis of variance (ANOVA) would be used to determine if there is any significant difference between the different strategies that are used to pre-medicate patients prior to paclitaxel infusion. P-values of less than 0.05 will be considered statistically significant.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Adult female patients > 18 years of age
Patients of the Loma Linda University Health (LLUH) gynecologic oncology and breastoncology service
Confirmed breast or gynecologic cancer diagnosis of any stage and any gynecologic orbreast malignancy
Planned treatment with paclitaxel containing regimen either in the adjuvant settingor for palliation
Planned treatment with paclitaxel should be for 3 or more cycles given as a weeklyor every 3 weeks cycle
Paclitaxel should be given as a monotherapy or as part of a combination regimen. Ifpaclitaxel is part of a regimen containing other drugs, the following conditionsmust be met:
Paclitaxel will be the first chemotherapy regimen to be infused when patientcomes in for treatment
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
Patients should have no prior exposure to taxanes (this includes: paclitaxel,docetaxel, and protein-bound paclitaxel)
The chemotherapy treatment should be at one of the LLUH Adult Cancer Centers
The patient should be an English or Spanish speaking patient

Exclusion

Exclusion Criteria:

Patients who are not with the gynecologic or breast oncology service
Patients who are with the gynecologic oncology or breast oncology service but arenot receiving paclitaxel either as a monotherapy or in combination with otherregimen
Patients who have had prior exposure to taxanes (this includes: paclitaxel,docetaxel, and protein-bound paclitaxel)
Patients who are currently on steroid therapy and it is anticipated that therapywill not be discontinued at least a week prior to start of chemotherapy
Patients with autoimmune diseases, malignancies, and any other co-morbid conditionthat might require steroid therapy during chemotherapy. This includes, but notlimited to:
Crohn's disease
Immune thrombocytopenia
Lupus nephritis
Multiple sclerosis
Primary brain tumors
Multiple Myeloma
Hodgkin's Lymphoma
Patients with uncontrolled diabetes or diabetic or pre-diabetic patients withbaseline A1C levels > 8.5
Patients who are allergic to diphenhydramine and/or dexamethasone
Non-English and Non-Spanish speaking patients

Study Design

Dexamethasone

August 08, 2018

June 30, 2025

Study Description

One of the potentially serious and dose-limiting toxicities of paclitaxel is the development of hypersensitivity reactions (HSRs). Up to 42% of patients receiving paclitaxel experience an HSR, with serious (> grade 3) reactions observed in about 2% of patients. Paclitaxel prescribing information and many other references therefore strongly recommend pre-medicating patients who are to be treated with paclitaxel-containing regimen with a corticosteroid, a histamine-1 (H1), and a histamine-2 (H2) antagonist prior to paclitaxel infusion. This is done to help prevent or minimize the occurrence of HSRs that could be caused by treating patients with paclitaxel. However, the method and timing of administering these pre-medications (particularly in the case of dexamethasone) have not been standardized. The current and most commonly used methods of preventing paclitaxel HSR includes one of the following: 1. Administering oral dexamethasone (20 mg), 12 hours and 6 hours prior to paclitaxel infusion and intravenous administration of H1 and H2 receptor antagonists 30 minutes prior to paclitaxel infusion (Conventional method); 2. Administering intravenous dexamethasone (20 mg), concurrently with H1 and H2 antagonists, 30 minutes prior to paclitaxel infusion (Short-course method); 3. Administering oral dexamethasone (20 mg), 12 hours prior to treatment in addition to intravenous dexamethasone (20 mg), H1 and H2 receptor antagonists administered 30 minutes prior to paclitaxel infusion. The goal of this study is to do a single center, prospective, randomized, open-label study to determine the most effective method in preventing paclitaxel HSR among these three commonly used methods.

Connect with a study center

Loma Linda University Cancer Center
Loma Linda, California 92354
United States
Active - Recruiting

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