Effects of Aerobic Exercise on Cancer-Related Biomarkers, Functional Capacity, Cognitive Status and Quality of Life in Women With Breast Cancer
NCT Number: NCT06540612
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Breast Cancer Female|Quality of Life|Survivorship
Interventions: OTHER: Aerobic exercise|BEHAVIORAL: Physical activity counseling
Sponsor: Hasan Kalyoncu University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 69
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-05-15
Completion Date: 2025-08-15
Locations: Nahide FIDANCIOGLU, Yeni̇mahalle, Ankara, Turkey

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.

Primary Outcome Measures: Quality Of Life Questionnaire, Developed by the European Organization for Research and Treatment of Cancer, it is a multidimensional quality of life scale. This scale developed by Aaronson et al. consists of 30 questions in total. It consists of three subscales: 1-The Functional Scale consists of physical, role, cognitiv, emotional and social subscales. 2-General Health Statuse; 3-Symptom Scale consists, fatigue, nausea, vomiting, pain, shortness of breath, sleep disturbance, loss of appetite, constipation , diarrhea , and financial impact. The 28 questions on the functional and symptom scales consist of four options for each question: not at all (1 point), a little (2 points), quite a bit (3 points), a lot (4 points). In the general health scale, there are options from 1 to 7 points ranging from very poor to excellent. The lowest total score that patients can get from the functional score, symptom score and general health score is 0 and the highest score is 100., 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 Outcome Measures: Functional Capacity, The six-minute walk test for the assessment of functional capacity will be performed according to the American Thoracic Society criteria. The six-minute walk test will be performed on a flat, unobstructed surface. Heart rate, blood pressure, oxygen saturation, dyspnea and fatigue levels according to the modified Borg scale will be determined before and after the test. The content of the test will be explained to the participants. During the test, the participants will be told that they will walk at their daily walking pace for 6 minutes and that they can stop and rest whenever they want. All participants will be tested to walk for 6 minutes and their walking distances will be measured and recorded. The test will be repeated 2 times at 20 minute intervals. In the measurements, all protocols applied in the first test will be applied again. The first results will be used for patients who do not participate in the retest., 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 Outcome Measures: Cognitive Status, The Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) Questionnaire will be used to assess the cognitive status of individuals. FACT-COG is a form filled out by the patient to assess chemotherapy-induced behavioral cognitive impairment and treatment, questioning the last 7 days. This form, evaluates cognitive sensitivity, attention and coordination, memory, verbal fluency, functional interference, observations of others about the individual, change in functionality compared to before and quality of life parameters. It consists of 4 sub-headings: The questions in the sections of perceived cognitive impairments, other people's comments, perceived cognitive skills and impact on quality of life are scored between 0-4. The perceived cognitive impairments and perceived cognitive abilities subsections contain the opposite questions and the last 2 questions are not included in the scoring. Increasing total score indicates improving cognitive function., 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.|Biomarkers(CRP, IGF-1, insulin, leptin, IL-6, TNF-α, adiponectin), After an eight-hour overnight fast, venous blood samples will be collected from the antecubital vein in a sitting position. Dry tubes (BD Vacutainer, SST II Advance, Austria) with gel separator containing clot activator will be used for serum collection. Blood samples will be centrifuged at 3500 rpm for 10 min and serum will be separated. Sera will be stored in a deep freezer (Nüve DF 290, Turkey) at -80˚C. Starting from the day before the day of analysis, the frozen samples will be gradually thawed at -20˚C, +4˚C and room temperature, respectively. In order to avoid repeated freezing and thawing, laboratory work will be performed after all samples have been collected. Standards, kits and sera will be brought to room temperature (18- 26°C). Serum samples will be analyzed according to routine laboratory procedures. All parameters will be run in 2 replicates., 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.