Ignite Creation Date:
2024-10-25 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06540612
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-08-02
Brief Title:
Effects of Aerobic Exercise on Cancer-Related Biomarkers Functional Capacity Cognitive Status and Quality of Life in Women With Breast Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effects of Aerobic Exercise on Cancer-Related Biomarkers Functional Capacity Cognitive Status and Quality of Life in Women With Breast Cancer
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to emphasize the exercise-induced changes in some circulating biomarkers CRP IGF-1insulin like growth factor insulin leptin IL-6interleukin-6 TNF-αtumor necrosis factor adiponectin quality of life functional capacity cognitive functions and after aerobic exercise in women diagnosed with breast cancer in remission period
The women who will participate in the study consist of breast cancer survivors aged 18-65 years
The hypothesis of this study
Exercise program in women diagnosed with breast cancer in remission positively affects the levels of circulating biomarkers CRP IGF-1 insulin leptin IL-6 TNFα and adiponectin and improves quality of life functional capacity and cognitive functions
Participants will be divided into 3 groups The first group will receive moderate intensity aerobic exercise 3 times a week for 12 weeks The second group will receive physical activity counseling by a physiotherapist for 12 weeks The third group will continue their daily routines and no intervention will be performed The evaluations will be repeated three times for all three groups at baseline after six weeks and after twelve weeks
The women who will participate in the study consist of breast cancer survivors aged 18-65 years
The hypothesis of this study
Exercise program in women diagnosed with breast cancer in remission positively affects the levels of circulating biomarkers CRP IGF-1 insulin leptin IL-6 TNFα and adiponectin and improves quality of life functional capacity and cognitive functions
Participants will be divided into 3 groups The first group will receive moderate intensity aerobic exercise 3 times a week for 12 weeks The second group will receive physical activity counseling by a physiotherapist for 12 weeks The third group will continue their daily routines and no intervention will be performed The evaluations will be repeated three times for all three groups at baseline after six weeks and after twelve weeks
Detailed Description:
Breast cancer is the most common malignant tumor in women with a rate of 30 Again 15 of cancer-related deaths in women are due to breast cancer Breast cancer whose incidence among women is increasing in our country is seen in one out of every four women diagnosed with cancer Approximately one in every eight women is at lifelong risk of developing breast cancer Turkish Society of Medical Oncology Breast Cancer 2019
As a side effect of the disease and multimodal anticancer interventions breast cancer patients may experience cancer-related physical and psychological symptoms such as cancer-related fatigue decreased muscle mass loss of strength decreased functional capacity and pain These symptoms create a vicious cycle leading to deterioration in quality of life Oncological rehabilitation aims to reduce such symptoms through multimodal transprofessionally delivered goal-oriented and person-centered coordinated interventions Oncological rehabilitation is available before during between and after cancer treatments
Inflammation is the hallmark of cancer and is associated with poor clinical outcomes in patients with various types of solid tumors Inflammation activates certain signaling pathways to promote cell survival proliferation migration and invasion Preclinical studies show that reducing inflammation and targeting inflammatory signaling pathways slows cell growth and delays tumor progression Furthermore obesity causes chronic inflammation that can promote malignant cell growth The anti-inflammatory benefit of aerobic exercise may arise in part due to a reduction in adiposity
Decreased immune function often accompanies anti-cancer therapies and reduces overall quality of life Compromised chronic inflammation and cellular immunity are major concerns as both promote a pro-tumor environment that may contribute to disease progression Therefore there is a need to identify options to manage inflammation while maximizing immune function in cancer survivorship Exercise is a potentially attractive option However the role of exercise training on immune function and inflammatory markers is not well addressed in current exercise oncology guidelines
Immune cell rates and function provide direct evidence of immunity in cancer survivors Cytokines are often categorized as pro- or anti-inflammatory some function as both such as interleukin-6 Higher circulating levels of pro-inflammatory cytokines are linked to cancer-related outcomes For example breast cancer patients with advanced tumors have higher circulating levels of tumor necrosis factor TNF compared with healthy individuals Previous systematic reviews had concluded that exercise training had no effect on circulating cytokines in cancer survivors overall However a recent meta-analysis using a more homogeneous population reported positive effects of TNF interleukin-6 interleukin-8 and interleukin-2 in breast cancer Despite the role of the inflammatory state in various cancers and the growing body of literature examining cytokines in exercise oncology it remains unclear whether the benefits of exercise extend beyond breast cancer
As a side effect of the disease and multimodal anticancer interventions breast cancer patients may experience cancer-related physical and psychological symptoms such as cancer-related fatigue decreased muscle mass loss of strength decreased functional capacity and pain These symptoms create a vicious cycle leading to deterioration in quality of life Oncological rehabilitation aims to reduce such symptoms through multimodal transprofessionally delivered goal-oriented and person-centered coordinated interventions Oncological rehabilitation is available before during between and after cancer treatments
Inflammation is the hallmark of cancer and is associated with poor clinical outcomes in patients with various types of solid tumors Inflammation activates certain signaling pathways to promote cell survival proliferation migration and invasion Preclinical studies show that reducing inflammation and targeting inflammatory signaling pathways slows cell growth and delays tumor progression Furthermore obesity causes chronic inflammation that can promote malignant cell growth The anti-inflammatory benefit of aerobic exercise may arise in part due to a reduction in adiposity
Decreased immune function often accompanies anti-cancer therapies and reduces overall quality of life Compromised chronic inflammation and cellular immunity are major concerns as both promote a pro-tumor environment that may contribute to disease progression Therefore there is a need to identify options to manage inflammation while maximizing immune function in cancer survivorship Exercise is a potentially attractive option However the role of exercise training on immune function and inflammatory markers is not well addressed in current exercise oncology guidelines
Immune cell rates and function provide direct evidence of immunity in cancer survivors Cytokines are often categorized as pro- or anti-inflammatory some function as both such as interleukin-6 Higher circulating levels of pro-inflammatory cytokines are linked to cancer-related outcomes For example breast cancer patients with advanced tumors have higher circulating levels of tumor necrosis factor TNF compared with healthy individuals Previous systematic reviews had concluded that exercise training had no effect on circulating cytokines in cancer survivors overall However a recent meta-analysis using a more homogeneous population reported positive effects of TNF interleukin-6 interleukin-8 and interleukin-2 in breast cancer Despite the role of the inflammatory state in various cancers and the growing body of literature examining cytokines in exercise oncology it remains unclear whether the benefits of exercise extend beyond breast cancer
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None