80 Participants Needed

Exercise Intervention for Breast Cancer-Related Inflammation

(DECODE Trial)

Recruiting at 1 trial location
CJ
MS
Overseen ByMelinda Stolley, PhD
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Medical College of Wisconsin
Must be taking: Anthracyclines, Anti-Her2
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

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?

Research shows that exercise interventions are generally safe for breast cancer patients, even during chemotherapy. Studies have found that supervised exercise can help manage inflammation and reduce fatigue without significant safety concerns.16789

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

Self-identifies as Black/African American or non-Hispanic White
Willing to complete all study activities
I am undergoing treatment for breast cancer that includes specific chemotherapy drugs or targeted therapy.
See 3 more

Exclusion Criteria

I have heart disease with symptoms or an ejection fraction below 50%.
Non-English speaking
I have had chemotherapy or targeted head and neck cancer treatment before.
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 16-20 week intervention promoting exercise during cancer treatment, including regular physical activity and resistance training.

16-20 weeks
2-4 visits (in-person), weekly text messages

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 12-15 months.

12-15 months
3 visits (in-person)

Treatment Details

Interventions

  • Taking Charge during Treatment (TCT) Intervention
Trial Overview The study tests the 'Taking Charge during Treatment' (TCT) Intervention aimed at understanding how cancer treatment-induced inflammation affects blood vessel function and if exercise can mitigate these effects. It uses advanced -omics technologies to predict microvascular dysfunction from chemotherapy.
Participant Groups
2Treatment groups
Active Control
Group I: Taking Charge during Treatment (TCT) InterventionActive Control1 Intervention
Taking Charge during Treatment (TCT) Intervention. TCT is a 16-20week intervention that promotes adoption of the ACSM exercise guidelines for cancer survivors during treatment, including regular moderate to vigorous physical activity (150 minutes per week of moderate activity or 75 minutes per week of vigorous activity) and a minimum of twice weekly resistance training (RT) minutes during CTx and after. Participants will receive "Take Charge" program binder, 2-4 x weekly text messaging, activity tracker and resistance bands.
Group II: Control GroupActive Control1 Intervention
To ensure scientific rigor allowing us to test causal pathways associated with exercise, women will be randomized to the TCT intervention or control group arm. The control group will not receive the TCT intervention The investigators experience teaches us that to increase the likelihood of retaining control group participants, the investigators must offer some resources. Thus, the investigators will provide the control group with a one-page summary of the American College of Sports Medicine exercise recommendations, and the "Take Charge" program binder at the completion of the study. Participants will also receive resistance bands and activity tracker at the end of the study. 95 The investigators will also send weekly text messages with supportive content not related to exercise or lifestyle (i.e., a riddle, "take a moment to smile today," a picture of a baby animal).

Find a Clinic Near You

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials
645
Recruited
1,180,000+

University of Illinois at Chicago

Collaborator

Trials
653
Recruited
1,574,000+

Findings from Research

A 16-week exercise intervention involving resistance and high-intensity interval training (RT-HIIT) significantly reduced inflammation markers (IL-6 and CD8a) in breast cancer patients undergoing chemotherapy, which correlated with lower levels of fatigue.
The study found that changes in these inflammation markers mediated the exercise's beneficial effects on fatigue, suggesting that exercise can be an effective strategy to combat chemotherapy-induced fatigue by reducing inflammation.
Inflammation Mediates Exercise Effects on Fatigue in Patients with Breast Cancer.Hiensch, AE., Mijwel, S., Bargiela, D., et al.[2023]
A 12-week study involving 40 breast cancer survivors showed that high-intensity interval training (HIIT) led to greater reductions in body mass, fat mass, and inflammatory markers (like TNF-α and IL-6) compared to moderate-intensity continuous training (MICT).
HIIT also significantly improved physical fitness, as indicated by increases in VO2peak and lower body strength, suggesting it may be a more effective exercise therapy for managing chronic inflammation and improving health outcomes in breast cancer survivors.
The Effects of High-Intensity Interval Training vs. Moderate-Intensity Continuous Training on Inflammatory Markers, Body Composition, and Physical Fitness in Overweight/Obese Survivors of Breast Cancer: A Randomized Controlled Clinical Trial.Hooshmand Moghadam, B., Golestani, F., Bagheri, R., et al.[2021]
In a study involving 11 breast cancer survivors, 16 weeks of combined aerobic and resistance exercise training significantly reduced the production of pro-inflammatory cytokines IL-1ß and IL-6 in monocytes, suggesting an anti-inflammatory effect of exercise.
Acute exercise led to a temporary decrease in the expression of toll-like receptors (TLR2 and TLR4) on monocytes, indicating a potential immediate response to exercise, although this effect was not sustained with ongoing training.
Exercise-induced modulation of monocytes in breast cancer survivors.Khosravi, N., Hanson, ED., Farajivafa, V., et al.[2022]

References

Inflammation Mediates Exercise Effects on Fatigue in Patients with Breast Cancer. [2023]
The Effects of High-Intensity Interval Training vs. Moderate-Intensity Continuous Training on Inflammatory Markers, Body Composition, and Physical Fitness in Overweight/Obese Survivors of Breast Cancer: A Randomized Controlled Clinical Trial. [2021]
Exercise-induced modulation of monocytes in breast cancer survivors. [2022]
Exercise intensity and markers of inflammation during and after (neo-) adjuvant cancer treatment. [2022]
The Effect of Exercise Training on Mediators of Inflammation in Breast Cancer Survivors: A Systematic Review with Meta-analysis. [2018]
Effect of exercise on markers of inflammation in breast cancer survivors: the Yale exercise and survivorship study. [2022]
Bootcamp during neoadjuvant chemotherapy for breast cancer: a randomized pilot trial. [2021]
Effects of supervised exercise during adjuvant endocrine therapy in overweight or obese patients with breast cancer: The I-MOVE study. [2021]
Effects of exercise training on cardiac toxicity markers in women with breast cancer undergoing chemotherapy with anthracyclines: a randomized controlled trial. [2023]
Exercise training and cytokines in breast cancer survivors. [2011]
11.United Statespubmed.ncbi.nlm.nih.gov
Breast Cancer Survivors, Common Markers of Inflammation, and Exercise: A Narrative Review. [2020]
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