Randomized, Blinded Trial of Mesna to Prevent Doxorubicin-induced Plasma Protein Oxidation and TNF-α Release
Sponsor study identifier
interventional
32
1 country
1
Study Start
September 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2012
Actual (reported)Study Completion
April 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2010
Date type not reportedThis date has not been verified as actual or estimated.
September 17, 2010
Actual (reported)September 20, 2010
Actual (reported)August 2012
Actual (reported)April 2015
Actual (reported)February 24, 2016
Actual (reported)TNF-alpha Levels in Patients Receiving Doxorubicin Containing Chemotherapy
Continuous Measure of TNF-alpha at the 4 time points outlined in the protocol for each group.
prior to and 3 hours post doxorubicin and between cycles 1 and 2
Protein Carbonyl Percent Changes From Baseline in Patients Receiving Doxorubicin Containing Chemotherapy
prior to and 3 hours post doxorubicin and between cycles 1 and 2
Plasma HNE Percent Changes From Baseline in Patients Receiving Doxorubicin Containing Chemotherapy
prior to and 3 hours post doxorubicin and between cycles 1 and 2
Troponin Levels in Patients Receiving Doxorubicin Containing Chemotherapy
prior to and 3 hours post doxorubicin and between cycles 1 and 2
B-type Natriuretic Peptide (BNP) Blood Levels in Patients Receiving Doxorubicin Containing Chemotherapy
prior to and 3 hours post doxorubicin and between cycles 1 and 2
Saline infused over 15 minutes administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) with following Cyclophosphamide 6 hours post doxorubicin during 1st cycle, then Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion with following Cyclophosphamide 6 hours post doxorubicin during 2nd cycle
Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion with following Cyclophosphamide 6 hours post doxorubicin during 1st cycle, then Saline administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) with following Cyclophosphamide 6 hours post doxorubicin during 2nd cycle
Mesna: 360 mg/m2 in 50 mL normal saline (NS) either on cycle 2 or cycle 1, day 1. Infused over 15 minutes
Saline (used as a placebo) infused over the same time as mesna intervention
University of Kentucky Markey Cancer Center
Lexington, Kentucky, 40536, United States
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.
We did not measure any cognitive outcomes. We did not measure levels of anti-inflammatory cytokines, which could play a role in pathophysiology of Chemotherapy induced cognitive impairment (CICI). Small sample size, needs future trials to confirm.
Mara Chambers, M.D.
Markey Cancer Center
32 participants (actual enrollment reported by the registry).
First Submitted
September 17, 2010
First Posted
September 20, 2010
Study Start
September 2010
Date type not reportedThis date has not been verified as actual or estimated.
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.
600 mg/m2 IV over 30 minutes. Start 6 hours after doxorubicin started.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
August 2012
Actual (reported)Study Completion
April 2015
Actual (reported)Last Updated
February 24, 2016
Results First Posted
February 24, 2016
Record last verified: 2016-01
The de-identified data is already available as part of the published article supplement. PubMed Identification (ID) # 25909710
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: