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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 to 3 hours

Awards & highlights

Study Summary

This trial is testing which of 3 methods is best at preventing bad reactions to paclitaxel infusions in cancer patients. The methods being tested are: (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

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

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 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Loma Linda UniversityLead Sponsor

306 Previous Clinical Trials

260,718 Total Patients Enrolled

Linda Hong, MDPrincipal InvestigatorLoma Linda University Cancer Center

Media Library

Short-Course Clinical Trial Eligibility Overview. Trial Name: NCT03598426 — Phase 3

Allergic Reaction Research Study Groups: Short-Course, Combined, Conventional

Allergic Reaction Clinical Trial 2023: Short-Course Highlights & Side Effects. Trial Name: NCT03598426 — Phase 3

Short-Course 2023 Treatment Timeline for Medical Study. Trial Name: NCT03598426 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What does Conventional usually help with?

"Ophthalmia, sympathetic, and branch retinal vein occlusion are a few of the conditions that can be treated by conventional intervention. Additionally, this method is often used to combat macular edema."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Linda Hong, MD 2018. "Conventional Prophylactic Oral Dexamethasone vs Short-course IV Dexamethasone in Paclitaxel Hypersensitivity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03598426.

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