Trials / Completed

CompletedNCT04862585

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

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

Status: Completed
Phase: Phase 2 / Phase 3
Study type: Interventional
Enrollment: 130 (actual)

Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVE: I. To estimate the difference in rates of infusion hypersensitivity reaction (HSR) requiring parenteral rescue medications following the discontinuation of pre-medications after 2 doses of paclitaxel, compared to continuing premedications, in breast cancer patients who have not experienced an infusion HSR with their first 2 paclitaxel doses. OUTLINE: Patients receive paclitaxel per standard of care as a single agent or in combination with dexamethasone intravenously (IV) and/or orally (PO), diphenhydramine IV and/or PO and either famotidine IV and/or PO, ranitidine IV and/or PO or cimetidine IV and/or PO. Patients who don't experience any infusion hypersensitivity reaction after the first 2 doses of paclitaxel are randomized to 1 of 2 arms. ARM I (STANDARD OF CARE): Patients continue on pre-medications (dexamethasone, diphenhydramine, famotidine/ranitidine/cimetidine) with all future doses of paclitaxel. ARM II (EXPERIMENTAL): Patients discontinue premedications (dexamethasone, diphenhydramine, famotidine/ranitidine/cimetidine) with all future doses of paclitaxel, unless patient develops a subsequent infusion HSR.

Conditions

Interventions

Type	Name	Description
DRUG	Cimetidine	Given IV and/or PO
DRUG	Dexamethasone	Given IV and/or PO
DRUG	Diphenhydramine	Given IV and/or PO
DRUG	Famotidine	Given IV and/or PO
DRUG	Paclitaxel	Weekly or every 14 day dosing
OTHER	Quality-of-Life Assessment	Ancillary studies
DRUG	Ranitidine	Given IV and/or PO

Timeline

Start date: 2021-10-07
Primary completion: 2024-06-21
Completion: 2024-06-21
First posted: 2021-04-28
Last updated: 2025-08-20
Results posted: 2025-08-20

Locations

1 site across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT04862585. Inclusion in this directory is not an endorsement.