NCT05223322: DECODE

Understanding and Addressing Disparities in Cancer Therapy Induced Inflammation and Associated Endothelial Dysfunction

Recruiting now NA Last updated 2 May 2025

What this trial tests

NA trial testing Taking Charge during Treatment (TCT) Intervention in Breast Cancer in 80 participants. Currently enrolling.

Timeline

1 March 2022

Primary endpoint
1 July 2026

1 July 2026

Quick facts

Lead sponsor	Medical College of Wisconsin
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	80
Start date	1 March 2022
Primary completion	1 July 2026
Estimated completion	1 July 2026
Sites	2 locations across United States

Drugs / interventions tested

• Taking Charge during Treatment (TCT) Intervention

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →

Sponsor

Medical College of Wisconsin

Who can join

Adults 18 to 100, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Very little is understood about the off-target vascular mechanisms of anti-cancer drug toxicity and the impact of exercise on these changes. Much of what has been learned about molecular pathways regulating vascular endothelial function has been established by logical expansion of knowledge obtained through experimental studies (e.g., discovery of endothelium-derived relaxing factor/nitric oxide). Within the last 10 years technological advancements of -omics approaches, such as RNA-sequencing and shotgun proteomics, have dramatically reduced the cost and technical challenge of accessing these tools for discovery-based research. Investigators are now able to obtain unbiased datasets showing changes in transcript or protein expression within complex samples. With cost and accessibility of sequencing is no longer being substantial bottleneck, one of major challenges researchers now face is determining how to meaningfully interpret profiles from large datasets. The extensive characterization of molecular pathways impacting inflammatory responses, endothelial function and angiogenesis, the pathway and network analysis tools will be an asset for identification molecular pathways relevant to alterations in microvascular endothelial function. The investigators preliminary studies on only a small number of samples highlights this potential of the proposed approach to lead to identify personalized medicine-based profiles that will predict patients are likely to develop microvascular endothelial dysfunction from CTx.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Take charge during treatment: a protocol for a pilot study to evaluate the impact of exercise on cardiovascular biomarkers among black and white breast cancer patients undergoing treatment.
   Do Couto N, Hidde M, Grigoriadis G, Sparapani R, et al · · 2025 · PMID 40841694 · DOI 10.1186/s40959-025-00378-7