Trial · NCT01205503

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

NCT01205503, Phase 2, Completed, Mara Chambers; results first posted 2016-02-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Trial of Mesna to Prevent Doxorubicin-induced Plasma Protein Oxidation and Tumor Necrosis Factor Alpha (TNF-α) Release. Trials, record NCT01205503. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01205503

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Trial of Mesna to Prevent Doxorubicin-induced Plasma Protein Oxidation and Tumor Necrosis Factor Alpha (TNF-α) Release
NCT number: NCT01205503
Status: Completed
Phases: Phase 2
Enrollment: 32 participants, actual
Lead sponsor: Mara Chambers
Conditions: Breast Cancer, Non-Hodgkin's Lymphoma
Interventions: Mesna, Saline, Doxorubicin, Cyclophosphamide
First posted: 2010-09-20
Last updated: 2016-02-24
Results first posted: 2016-02-24
Limitations and caveats: 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.

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	TNF-alpha Levels in Patients Receiving Doxorubicin Containing Chemotherapy	prior to and 3 hours post doxorubicin and between cycles 1 and 2	Continuous Measure of TNF-alpha at the 4 time points outlined in the protocol for each group.
Secondary	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	Continuous Measure of percent changes from baseline of Protein Carbonyl at the 4 time points outlined in the protocol for each group. All measurements after naive baseline were adjusted as percent change from each individual's baseline measure.
Secondary	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	Continuous Measure of the percent change from baseline of Plasma HNE at the 4 time points outlined in the protocol for each group. All measurements after naive baseline were adjusted as percent change from each individual's baseline measure.
Secondary	Troponin Levels in Patients Receiving Doxorubicin Containing Chemotherapy	prior to and 3 hours post doxorubicin and between cycles 1 and 2	Continuous Measure of troponin at the 4 time points outlined in the protocol for each group.
Secondary	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	Continuous Measure of BNP at the 4 time points outlined in protocol for each of the groups. This is a 32-amino acid polypeptide secreted by heart ventricles in response to excessive stretching of cardiomyocytes.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	TNF-alpha Levels in Patients Receiving Doxorubicin Containing Chemotherapy	prior to and 3 hours post doxorubicin and between cycles 1 and 2	log(pg/ml)	GEOMETRIC_MEAN
SECONDARY	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	Percent Change from Baseline	GEOMETRIC_MEAN
SECONDARY	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	Percent Change from Baseline	GEOMETRIC_MEAN
SECONDARY	Troponin Levels in Patients Receiving Doxorubicin Containing Chemotherapy	prior to and 3 hours post doxorubicin and between cycles 1 and 2	ng/ml	GEOMETRIC_MEAN
SECONDARY	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	pg/ml	GEOMETRIC_MEAN

Source ClinicalTrials.gov

Results by group36

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
TNF-alpha Levels in Patients Receiving Doxorubicin Containing Chemotherapy	Cycle 1 Saline; Cycle 2 Mesna	Cycle 1 Pre	3.55	95% Confidence Interval 1.96 to 6.42	log(pg/ml)
TNF-alpha Levels in Patients Receiving Doxorubicin Containing Chemotherapy	Cycle 1 Mesna; Cycle 2 Saline	Cycle 1 Pre	3.68	95% Confidence Interval 1.98 to 6.81	log(pg/ml)
TNF-alpha Levels in Patients Receiving Doxorubicin Containing Chemotherapy	Cycle 1 Saline; Cycle 2 Mesna	Cycle 1 Post	2.95	95% Confidence Interval 1.54 to 5.64	log(pg/ml)
TNF-alpha Levels in Patients Receiving Doxorubicin Containing Chemotherapy	Cycle 1 Mesna; Cycle 2 Saline	Cycle 1 Post	3.18	95% Confidence Interval 1.79 to 5.64	log(pg/ml)
TNF-alpha Levels in Patients Receiving Doxorubicin Containing Chemotherapy	Cycle 1 Saline; Cycle 2 Mesna	Cycle 2 Pre	2.26	95% Confidence Interval 1.37 to 3.73	log(pg/ml)
TNF-alpha Levels in Patients Receiving Doxorubicin Containing Chemotherapy	Cycle 1 Mesna; Cycle 2 Saline	Cycle 2 Pre	1.67	95% Confidence Interval 1.35 to 2.07	log(pg/ml)
TNF-alpha Levels in Patients Receiving Doxorubicin Containing Chemotherapy	Cycle 1 Saline; Cycle 2 Mesna	Cycle 2 Post	1.78	95% Confidence Interval 1.05 to 3.03	log(pg/ml)
TNF-alpha Levels in Patients Receiving Doxorubicin Containing Chemotherapy	Cycle 1 Mesna; Cycle 2 Saline	Cycle 2 Post	1.29	95% Confidence Interval 1.01 to 1.65	log(pg/ml)
Protein Carbonyl Percent Changes From Baseline in Patients Receiving Doxorubicin Containing Chemotherapy	Cycle 1 Saline; Cycle 2 Mesna	Cycle 1 Post	108.82	95% Confidence Interval 88.20 to 134.26	Percent Change from Baseline
Protein Carbonyl Percent Changes From Baseline in Patients Receiving Doxorubicin Containing Chemotherapy	Cycle 1 Mesna; Cycle 2 Saline	Cycle 1 Post	73.54	95% Confidence Interval 48.09 to 112.42	Percent Change from Baseline

1 to 10 of 36Source ClinicalTrials.gov

See all 36 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
First Intervention (1st Cycle)	STARTED	Cycle 1 Saline; Cycle 2 Mesna	16
First Intervention (1st Cycle)	STARTED	Cycle 1 Mesna; Cycle 2 Saline	16
First Intervention (1st Cycle)	COMPLETED	Cycle 1 Saline; Cycle 2 Mesna	16
First Intervention (1st Cycle)	COMPLETED	Cycle 1 Mesna; Cycle 2 Saline	16
First Intervention (1st Cycle)	NOT COMPLETED	Cycle 1 Saline; Cycle 2 Mesna	0
First Intervention (1st Cycle)	NOT COMPLETED	Cycle 1 Mesna; Cycle 2 Saline	0
Second Intervention (2nd Cycle)	STARTED	Cycle 1 Saline; Cycle 2 Mesna	16
Second Intervention (2nd Cycle)	STARTED	Cycle 1 Mesna; Cycle 2 Saline	16
Second Intervention (2nd Cycle)	COMPLETED	Cycle 1 Saline; Cycle 2 Mesna	16
Second Intervention (2nd Cycle)	COMPLETED	Cycle 1 Mesna; Cycle 2 Saline	16

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events140

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Alanine aminotransferase increased	Investigations	Mesna	4	32	4
other	Alanine aminotransferase increased	Investigations	Saline	3	32	3
other	Alkaline phosphatase increased	Investigations	Mesna	1	32	1
other	Alkaline phosphatase increased	Investigations	Saline	1	32	1
other	Allergic rhinitis	Respiratory, thoracic and mediastinal disorders	Mesna	1	32	1
other	Allergic rhinitis	Respiratory, thoracic and mediastinal disorders	Saline	1	32	1
other	Anemia	Blood and lymphatic system disorders	Mesna	9	32	9
other	Anemia	Blood and lymphatic system disorders	Saline	15	32	15
other	Anorexia	Metabolism and nutrition disorders	Mesna	0	32	0
other	Anorexia	Metabolism and nutrition disorders	Saline	1	32	1

1 to 10 of 140Source ClinicalTrials.gov

See all 140 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Mesna
Total, all-cause mortality	Saline
Total, other adverse events	Mesna	29	32
Total, other adverse events	Saline	30	32
Total, serious adverse events	Mesna	1	32
Total, serious adverse events	Saline	1	32

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
25909710	RESULT

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Mesna vs Saline: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01205503

GET https://conductscience.org/api/trials/v1/NCT01205503/results?page=2

API reference For AI assistants