CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 32 enrolled
Drug / intervention
Mesna +3 moredrug
Likely dose
Mesna 360 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01205503
NCT01205503Phase 2Completed
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Randomized, Blinded Trial of Mesna to Prevent Doxorubicin-induced Plasma Protein Oxidation and TNF-α Release

Mara Chambers·interventional·Posted Sep 20, 2010·Updated Feb 24, 2016

In Brief

A Phase 2 clinical trial evaluating Mesna, Saline, and 2 other interventions for Breast Cancer and Non-Hodgkin's Lymphoma. Completed, enrolled 32 participants across 1 site.

Detailed Summary

The purpose of this study is to determine whether the drug mesna is able to block a series of chemical changes that occur in the blood of patients who receive the chemotherapy medicine doxorubicin. The researchers believe these blood chemical changes may the cause of "cloudy thinking" or "chemobrain" that are reported by some patients receiving chemotherapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer, Non-Hodgkin's Lymphoma
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 20, 2010
Enrollment StartSep 1, 2010
Primary CompletionAug 1, 2012
Study CompletionApr 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 15.8 years ago

Interventions

Mesnadrug

Mesna: 360 mg/m2 in 50 mL normal saline (NS) either on cycle 2 or cycle 1, day 1. Infused over 15 minutes

Salinedrug

Saline (used as a placebo) infused over the same time as mesna intervention

Doxorubicindrug

60mg/m2 given IV over 15 minutes after receiving mesna or saline. Can allow for premedications of Ondansetron 8 mg orally, dexamethasone 12 mg orally, Aprepitant 125 mg orally.

Cyclophosphamidedrug

600 mg/m2 IV over 30 minutes. Start 6 hours after doxorubicin started.