Trial of Mesna to Prevent Doxorubicin-induced Plasma Protein Oxidation and Tumor Necrosis Factor Alpha (TNF-α) Release

NCT01205503 ↗

Phase 2 Completed 32 enrolled Mara Chambers

RandomizedCrossoverDouble-blindTreatment

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.

Timeline

Start: 2010-09
Primary completion: 2012-08
Completion: 2015-04

Outcome

Met primary endpoint

registry analysis (superiority or other test); Cycle 1 Saline; Cycle 2 Mesna vs Cycle 1 Mesna; Cycle 2 Saline; p = 0.014; Mixed Models Analysis NCT01205503 ↗

paper Co-administration of mesna with chemotherapy reduced post-treatment levels of TNF-related cytokines PMID 25909710 ↗

Publications

Results Hayslip J, Dressler EV, Weiss H, Taylor TJ, Chambers M, Noel T, Miriyala S, Keeney JT, Ren X, Sultana R, Vore M, Butterfield DA, St Clair D, Moscow JA. Plasma TNF-alpha and Soluble TNF Receptor Levels after Doxorubicin with or without Co-Administration of Mesna-A Randomized, Cross-Over Clinical Study. PLoS One. 2015 Apr 24;10(4):e0124988. doi: 10.1371/journal.pone.0124988. eCollection 2015.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	2-MERCAPTOETHANESULFONIC ACID	Small molecule	360 mg/m2	—
Background	Cyclophosphamide	Other / unclassified	600 mg/m2	Intravenous
Background	Doxorubicin	Other / unclassified	60 mg/m2	Intravenous