Effects of Aerobic Exercise on Cancer-Related Biomarkers, Functional Capacity, Cognitive Status and Quality of Life in Women With Breast Cancer

Trial Title: Effects of Aerobic Exercise on Cancer-Related Biomarkers, Functional Capacity, Cognitive Status and Quality of Life in Women With Breast Cancer

NCT ID: NCT06540612

Condition: Breast Cancer Female
Quality of Life
Survivorship

Conditions: Official terms:
Breast Neoplasms

Conditions: Keywords:
Breast Cancer
Rehabilitation
Biomarkers
Exercise

Study type: Interventional

Study phase: N/A

Overall status: Enrolling by invitation

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Supportive Care

Masking: Single (Outcomes Assessor)

Intervention:

Intervention type: Other
Intervention name: Aerobic exercise
Description: Aerobic exercise is a set of physical activities that work large muscle groups continuously and rhythmically.
Arm group label: Aerobic Exercise Intervention

Intervention type: Behavioral
Intervention name: Physical activity counseling
Description: Physical activity counselling is a service that provides personalized guidance and support to help individuals adopt a healthy lifestyle.
Arm group label: Physical activity counseling

Summary: This study aims to emphasize the exercise-induced changes in some circulating biomarkers (CRP, IGF-1(insulin like growth factor), insulin, leptin, IL-6(interleukin-6) , TNF-α(tumor 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.

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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Patients aged between 18 and 65 - Literate - Diagnosed with stage 2 breast cancer - Completed primary breast cancer treatment at least 6 months ago (excluding hormone therapy/aromatase inhibitors) - Provided cooperation - Female - Patients who are willing and willing to participate in the study Exclusion Criteria: - Those who are using psychotic, anxiolytic, antidepressant, analgesic and sleeping pills - Those with metastasis - Those with a history of lymphedema - Those with neurological disease - Those who are pregnant or breastfeeding - Uncontrolled hypertensive patients - Those who are incapable of verbal communication or physical movement

Gender: Female

Gender based: Yes

Minimum age: 18 Years

Maximum age: 65 Years

Healthy volunteers: No

Locations:

Facility:
Name: Nahide FIDANCIOGLU

Address:
City: Yeni̇mahalle
Country: Turkey

Start date: May 15, 2024

Completion date: August 15, 2025

Lead sponsor:
Agency: Hasan Kalyoncu University
Agency class: Other

Source: Hasan Kalyoncu University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06540612
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