Exercise Intervention for Breast Cancer-Related Inflammation
(DECODE Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators or your doctor for guidance.
What data supports the effectiveness of the treatment Taking Charge during Treatment (TCT) Intervention, Lynparza for breast cancer-related inflammation?
Research shows that exercise can reduce inflammation and fatigue in breast cancer patients, which are key components of the TCT Intervention. High-intensity interval training (HIIT) and moderate-intensity continuous training (MICT) have been found to improve inflammatory markers and physical fitness in breast cancer survivors, suggesting that exercise is beneficial in managing inflammation.12345
Is exercise intervention safe for breast cancer patients?
How does exercise intervention differ from other treatments for breast cancer-related inflammation?
Exercise intervention is unique because it naturally reduces inflammation by improving the levels of certain proteins in the body, like IL6 and TNFα, which are linked to inflammation. Unlike traditional drug treatments, exercise also enhances physical fitness and body composition, offering a holistic approach to managing breast cancer-related inflammation.2351011
What is the purpose of this trial?
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.
Eligibility Criteria
This trial is for adults assigned female at birth, diagnosed with non-metastatic breast cancer, receiving certain chemotherapy including anthracyclines or anti-Her2 therapy. Participants must be able to exercise safely and identify as Black/African American or non-Hispanic White. Excluded are those who don't speak English, have metastatic disease, are pregnant/lactating, have cardiovascular disease, prior similar treatments or significant recent weight loss.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo a 16-20 week intervention promoting exercise during cancer treatment, including regular physical activity and resistance training.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments at 12-15 months.
Treatment Details
Interventions
- Taking Charge during Treatment (TCT) Intervention
Find a Clinic Near You
Who Is Running the Clinical Trial?
Medical College of Wisconsin
Lead Sponsor
University of Illinois at Chicago
Collaborator