What side effects are associated with this type of intervention?

Common treatments for allergic reactions include dexamethasone and histamine receptor antagonists (H1 and H2 blockers). Dexamethasone, a corticosteroid, can cause side effects such as increased blood sugar levels, weight gain, mood swings, and increased risk of infections. Histamine receptor antagonists, such as diphenhydramine and loratadine, may cause drowsiness, dry mouth, dizziness, and gastrointestinal disturbances. Combining these treatments can effectively manage allergic reactions but may also increase the likelihood of experiencing these side effects.

What prior FDA approvals exist?

The FDA has approved several treatments for allergic reactions that involve anti-inflammatory and histamine blockade mechanisms. Dexamethasone, a corticosteroid, is commonly used for its potent anti-inflammatory effects. Histamine receptor antagonists, such as H1 blockers (e.g., diphenhydramine, cetirizine) and H2 blockers (e.g., ranitidine, famotidine), are also approved for managing allergic reactions by inhibiting the action of histamine, which is a key mediator in allergic responses. These treatments are often used in combination to provide comprehensive management of allergic reactions, similar to the protocols being studied in trials involving dexamethasone and histamine receptor antagonists.

What other types of research exist?

Promising novel alternatives for treating allergic reactions include monoclonal antibodies such as omalizumab, ligelizumab, and dupilumab. Omalizumab targets IgE and has shown efficacy in food allergies and asthma. Ligelizumab, with higher potency than omalizumab, is being evaluated for peanut allergies. Dupilumab inhibits IL-4 and IL-13 signaling, offering benefits for atopic dermatitis and potentially other allergic conditions.

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Dexamethasone Methods for Preventing Allergic Reactions to Chemotherapy

Phase 3

Recruiting

Led By Linda Hong, MD

Research Sponsored by Loma Linda University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Planned treatment with paclitaxel containing regimen either in the adjuvant setting or for palliation

Paclitaxel should be given as a monotherapy or as part of a combination regimen

Must not have

Patients with autoimmune diseases, malignancies, and any other co-morbid condition that might require steroid therapy during chemotherapy are excluded

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 to 3 hours

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial tests three different ways to prevent allergic reactions in women with gynecologic cancers who are treated with paclitaxel. The methods involve using steroids and antihistamines before the treatment. The goal is to find out which method works best to keep patients safe from allergic reactions. Paclitaxel is a plant product highly active in numerous cancers, but it has a significant incidence of hypersensitivity reactions, which are typically managed with steroids and antihistamines.

Who is the study for?

This trial is for adult female patients over 18 with breast or gynecologic cancer who will receive paclitaxel as their first chemo at LLUH Cancer Centers. They must not have had taxanes before, be English or Spanish speakers, and plan to undergo at least 3 cycles of treatment with specific regimens including paclitaxel.

What is being tested?

The study compares three methods to prevent hypersensitivity reactions from paclitaxel: conventional oral dexamethasone taken twice before infusion; short-course IV dexamethasone given just before infusion; and a combined method using both oral and IV dexamethasone.

What are the potential side effects?

Dexamethasone may cause side effects like increased blood sugar levels, mood changes, insomnia, stomach irritation, increased appetite, weight gain, fluid retention (swelling), and higher risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for treatment with a paclitaxel-based regimen.

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I am receiving paclitaxel alone or with other drugs.

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I am scheduled for at least 3 cycles of paclitaxel treatment.

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My chemotherapy is approved for this study.

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Paclitaxel will be my first chemotherapy treatment.

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I have never been treated with taxanes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have autoimmune diseases or other conditions that need steroids during chemotherapy.

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I am under care for gynecologic or breast cancer but not receiving paclitaxel.

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I have been treated with taxanes before.

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My diabetes is not under control, or my A1C level is above 8.5.

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I do not speak English or Spanish.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 to 3 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 to 3 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 to 3 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Least incidence of any-grade-paclitaxel-HSR first cycle

Secondary study objectives

Least incidence of any-grade-paclitaxel-HSR in the first and second cycles

Least incidence of any-grade-paclitaxel-HSR second cycle

Least incidence of grade 3 or more paclitaxel-HSR first cycle

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Active Control

Group I: Short-CourseActive Control1 Intervention

Intravenous administration of dexamethasone 20 mg, along with an intravenous administration of diphenhydramine 50 mg and famotidine 20 mg, administered 30 minutes prior to paclitaxel infusion.

Group II: CombinedActive Control1 Intervention

Oral dexamethasone (20 mg) at home, 12 hours prior to paclitaxel infusion. On the day of treatment at the clinic, an additional intravenous administration of dexamethasone 20 mg, along with an intravenous administration of diphenhydramine 50 mg and famotidine 20 mg, administered 30 minutes prior to paclitaxel infusion.

Group III: ConventionalActive Control1 Intervention

Oral dexamethasone (20 mg) at home, 12 hours and 6 hours prior to paclitaxel infusion. On the day of treatment at the clinic, an intravenous administration of diphenhydramine 50 mg and famotidine 20 mg, administered 30 minutes prior to paclitaxel infusion.

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Dexamethasone, a corticosteroid, works by suppressing the immune response and reducing inflammation, which helps alleviate symptoms such as swelling, redness, and itching. Histamine receptor antagonists, including H1 and H2 blockers, prevent histamine from binding to its receptors, thereby reducing symptoms like hives, itching, and nasal congestion. These mechanisms are vital for allergic reaction patients as they target both the inflammatory and histamine-mediated components of allergic responses, providing comprehensive symptom relief and preventing severe reactions.

Intranasal allergen challenge during corticosteroid treatment.Urticaria.