Safely Stopping Pre-medications in Patients With Breast Cancer Who Are Receiving Paclitaxel

ClinicalTrials.gov ID: NCT04862585

Public ClinicalTrials.gov record NCT04862585. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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Official title

Safely Stopping Pre-Medications in Patients Receiving Paclitaxel: A Randomized Trial

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This phase II/III trial investigates the difference in rates of infusion hypersensitivity reaction in patients with breast cancer who are receiving paclitaxel alone or in combination with other cancer drugs which require parenteral rescue medication after stopping standard pre-medications (dexamethasone, diphenhydramine, famotidine/cimetidine/ranitidine), compared to continuing premedications. Paclitaxel is a drug used to treat breast cancer, ovarian cancer, and autoimmune deficiency syndrome (AIDS)-related Kaposi sarcoma. It blocks cell growth by stopping cell division and may kill cancer cells. It is a type of antimitotic agent. However, there are side-effects and toxicities associated with repeat exposure to this pre-medication regimen. With prolonged use of paclitaxel, especially during weekly regimens, patients are exposed to repeat doses of drugs that prevent hypersensitivity reactions. Side effects include, but are not limited to, insomnia, gastritis, fluid retention, weight gain, mood changes and immune suppression. The information gained from this study may positively influence clinical practice and help researchers develop methods to safely stop pre-medications.

Study identification

NCT ID: NCT04862585
Recruitment status: Completed
Study type: Interventional
Phase: Phase 2, Phase 3
Lead sponsor: Ohio State University Comprehensive Cancer Center; Other
Enrollment: 130 participants

Conditions and interventions

Conditions

Interventions

Drug · Other

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Oct 6, 2021
Primary completion: Jun 20, 2024
Completion: Jun 20, 2024
Last update posted: Aug 19, 2025

2021 – 2024

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
Ohio State University Comprehensive Cancer Center	Columbus	Ohio	43210	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT04862585, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Aug 19, 2025 · Synced Sep 4, 2026

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The complete protocol, eligibility criteria, and contact information for NCT04862585 live on ClinicalTrials.gov.

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