Ignite Creation Date:
2024-07-17 @ 10:42 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06497322
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-06-25
Brief Title:
Exercise Intervention in Women Diagnosed With Triple-negative Breast Cancer Receiving Oncologic Treatment
Sponsor:
University Hospital of Cologne
Organization:
University Hospital of Cologne
Study Overview
Official Title:
Effectiveness of High-intensity Interval Training During Neoadjuvant Immunochemotherapy on Complete Remission in Patients With Triple-negative Breast Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this randomized controlled prospective two-arm intervention study the investigators plan to investigate the effects of high-intensity interval training in women diagnosed with triple-negative breast cancer Breast cancer is one of the most common cancers and one of the leading causes of cancer-related deaths worldwide Among the different subtypes triple-negative breast cancer accounts for about 15-20 of all breast cancer cases and is characterized by a more aggressive clinical course Recent results indicate that the percentage of patients with a pathologic complete response was 13 higher in the chemotherapy-immunotherapy group by 648 than in the placebo-chemotherapy group 512 High-intensity interval training has a positive effect on the immune system suggesting that it may improve the efficacy of chemo-immunotherapy leading to a higher rate of pathologic complete response pCR in patients with newly diagnosed triple-negative breast cancer In addition to the immunomodulatory effects this exercise model could boost microvascular perfusion thereby improving tumor perfusion enhancing chemo-immunotherapy and leading to better outcomes
Detailed Description:
Recent clinical trials showed promising results in patients with triple negative breast cancer TNBC who received four cycles of pembrolizumab at a dose of 200 mg every three weeks standard chemotherapy compared to patients who received placebo chemotherapy alone Importantly the overall risk of disease progression that precluded surgery local or distant recurrence occurrence of a second primary cancer or death from any cause was 37 lower with pembrolizumab chemotherapy compared to placebo chemotherapy Exercise training is a supportive multi-effect strategy with the ability to influence multiple organ systems There is growing epidemiologic evidence that a physically active lifestyle is associated with a lower risk of developing cancer particularly colon and breast cancer Recent preclinical studies suggest that exercise can control and attenuate the growth of tumor cells Therefore exercise could be a potential means to increase the rate of pCR in cancer patients in general High-intensity interval training resulted in higher cardiorespiratory fitness levels particularly in breast cancer and lung patients who exercised for at least 8 weeks with a significant improvement from 240 to 419 mL-min-1-kg-1 observed compared to control groups The aim of this study is to investigate the effects of HIIT training on immune system response and pCR rates most commonly defined as complete eradication of the tumor as a surrogate parameter for good prognosis during neoadjuvant immunochemotherapy in women with TNBC The working hypothesis is that HIIT training would activate the immune system and enhance the combination of neoadjuvant treatment leading to higher rates of pCR in the aerobic group compared to the usual treatment group Thus this exercise model may also promote microvascular perfusion improve tumor perfusion and potentially lead to more favorable outcomes in neoadjuvant therapy increasing the efficacy of systemic treatments and allowing for better therapeutic outcomes The researchers support the idea that high-intensity aerobic exercise may at least partially challenge the large heterogeneity in response to medical treatment in women with a first diagnosis of TNBC and lead to higher response rates in the experimental group
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None