Clinical trial NCT06540612: Effects of Aerobic Exercise on Cancer-Related Biomarkers, Functional Capacity, Cognitive Status and Quality of Life in Women With Breast Cancer
Official title: Effects of Aerobic Exercise on Cancer-Related Biomarkers, Functional Capacity, Cognitive Status and Quality of Life in Women With Breast Cancer
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Breast Cancer Female
Quality of Life
Survivorship
Keywords: Breast Cancer
Rehabilitation
Biomarkers
Exercise
Lead sponsor: Hasan Kalyoncu University
Sponsor class: OTHER
First posted: 2024-08-06
Enrollment: 69
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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

Primary outcomes:
measure: Quality Of Life Questionnaire
timeFrame: A total of three assessments will be made at the beginning of the study, at the end of 6 weeks, and at the end of 12 weeks.
Secondary outcomes:
measure: Functional Capacity
timeFrame: A total of three assessments will be made at the beginning of the study, at the end of 6 weeks, and at the end of 12 weeks.
Other outcomes:
measure: Cognitive Status
timeFrame: A total of three assessments will be made at the beginning of the study, at the end of 6 weeks, and at the end of 12 weeks.
measure: Biomarkers(CRP, IGF-1, insulin, leptin, IL-6, TNF-α, adiponectin)
timeFrame: A total of three assessments will be made at the beginning of the study, at the end of 6 weeks, and at the end of 12 weeks.
Locations:
city: Yeni̇mahalle
country: Turkey
facility: Nahide FIDANCIOGLU
state: Ankara
Study officials:
name: Nahide Fidancıoğlu
role: PRINCIPAL_INVESTIGATOR
References:
citation: Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020 Jan;70(1):7-30. doi: 10.3322/caac.21590. Epub 2020 Jan 8.
citation: Asher A, Myers JS. The effect of cancer treatment on cognitive function. Clin Adv Hematol Oncol. 2015 Jul;13(7):441-50.
citation: Erratum: ATS Statement: Guidelines for the Six-Minute Walk Test. Am J Respir Crit Care Med. 2016 May 15;193(10):1185. doi: 10.1164/rccm.19310erratum. No abstract available.
citation: Aggarwal BB, Gehlot P. Inflammation and cancer: how friendly is the relationship for cancer patients? Curr Opin Pharmacol. 2009 Aug;9(4):351-69. doi: 10.1016/j.coph.2009.06.020. Epub 2009 Aug 6.
citation: Furman D, Campisi J, Verdin E, Carrera-Bastos P, Targ S, Franceschi C, Ferrucci L, Gilroy DW, Fasano A, Miller GW, Miller AH, Mantovani A, Weyand CM, Barzilai N, Goronzy JJ, Rando TA, Effros RB, Lucia A, Kleinstreuer N, Slavich GM. Chronic inflammation in the etiology of disease across the life span. Nat Med. 2019 Dec;25(12):1822-1832. doi: 10.1038/s41591-019-0675-0. Epub 2019 Dec 5.
citation: Iyengar NM, Gucalp A, Dannenberg AJ, Hudis CA. Obesity and Cancer Mechanisms: Tumor Microenvironment and Inflammation. J Clin Oncol. 2016 Dec 10;34(35):4270-4276. doi: 10.1200/JCO.2016.67.4283. Epub 2016 Nov 7.
citation: Bower JE, Greendale G, Crosswell AD, Garet D, Sternlieb B, Ganz PA, Irwin MR, Olmstead R, Arevalo J, Cole SW. Yoga reduces inflammatory signaling in fatigued breast cancer survivors: a randomized controlled trial. Psychoneuroendocrinology. 2014 May;43:20-9. doi: 10.1016/j.psyneuen.2014.01.019. Epub 2014 Jan 30.
citation: Johnson DE, O'Keefe RA, Grandis JR. Targeting the IL-6/JAK/STAT3 signalling axis in cancer. Nat Rev Clin Oncol. 2018 Apr;15(4):234-248. doi: 10.1038/nrclinonc.2018.8. Epub 2018 Feb 6.
citation: Zomkowski K, Wittkopf PG, Baungarten Hugen Back B, Bergmann A, Dias M, Sperandio FF. Pain characteristics and quality of life of breast cancer survivors that return and do not return to work: an exploratory cross-sectional study. Disabil Rehabil. 2021 Dec;43(26):3821-3826. doi: 10.1080/09638288.2020.1759150. Epub 2020 May 12.
citation: Khosravi N, Stoner L, Farajivafa V, Hanson ED. Exercise training, circulating cytokine levels and immune function in cancer survivors: A meta-analysis. Brain Behav Immun. 2019 Oct;81:92-104. doi: 10.1016/j.bbi.2019.08.187. Epub 2019 Aug 24.
citation: Kokkonen K, Saarto T, Makinen T, Pohjola L, Kautio H, Jarvenpaa S, Puustjarvi-Sunabacka K. The functional capacity and quality of life of women with advanced breast cancer. Breast Cancer. 2017 Jan;24(1):128-136. doi: 10.1007/s12282-016-0687-2. Epub 2016 Mar 22.
citation: Al Maqbali M, Al Sinani M, Al Naamani Z, Al Badi K, Tanash MI. Prevalence of Fatigue in Patients With Cancer: A Systematic Review and Meta-Analysis. J Pain Symptom Manage. 2021 Jan;61(1):167-189.e14. doi: 10.1016/j.jpainsymman.2020.07.037. Epub 2020 Aug 5.
citation: Mantovani A, Allavena P, Sica A, Balkwill F. Cancer-related inflammation. Nature. 2008 Jul 24;454(7203):436-44. doi: 10.1038/nature07205.
citation: Klassen O, Schmidt ME, Ulrich CM, Schneeweiss A, Potthoff K, Steindorf K, Wiskemann J. Muscle strength in breast cancer patients receiving different treatment regimes. J Cachexia Sarcopenia Muscle. 2017 Apr;8(2):305-316. doi: 10.1002/jcsm.12165. Epub 2016 Nov 28.