NCT Number: NCT07798492
This study evaluates the effects of a 12-week supervised aerobic exercise program in women who have completed primary treatment for early-stage breast cancer and are in remission. The study aims to determine whether regular aerobic exercise is associated with changes in physical function, quality of life, cognitive function, and selected blood biomarkers.
Participants take part in a supervised aerobic exercise program for 12 weeks. Assessments are performed before the program, at week 6, and at week 12. These assessments include a walking test, questionnaires about quality of life and cognitive function, and blood sampling.
Blood samples are used to measure GDF15, NF-κB p105, and visfatin. Changes in these measures over the 12-week exercise period are evaluated together with changes in functional capacity and patient-reported outcomes.
This study is active but is not currently recruiting participants.
Notify Me18 year–65 year
Female
Interventional
Not applicable
Ankara Yildirim Beyazit University, Ankara, Turkey (Türkiye)
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Women aged 18-65 years. Histologically confirmed stage I-II nonmetastatic breast cancer. Completion of indicated primary cancer treatment at least 6 months before enrollment and currently in remission.
Ongoing endocrine therapy was permitted. No participation in regular structured physical activity during the preceding 6 months.
Medically eligible to participate in aerobic exercise and study assessments. Physician clearance to participate in aerobic exercise. Residing in or near the city where the study was conducted. Provision of written informed consent.
Exclusion criteria
Metastatic breast cancer. Clinically significant cardiovascular, respiratory, neurological, or musculoskeletal conditions that could limit safe participation in aerobic exercise.
Clinically significant lymphedema. Pregnancy or breastfeeding. Use within the preceding 8 weeks of antidepressants, anxiolytics, antipsychotics, chronic analgesics, or sedatives considered likely to influence cognitive assessments or biological outcomes.
Participants will complete a 12-week supervised aerobic exercise program. Exercise sessions will be performed according to the study protocol, with exercise intensity and progression monitored throughout the intervention. Functional capacity, patient-reported outcomes, and circulating biomarkers will be assessed at baseline, week 6, and week 12.
Time frame: Baseline, week 6, and week 12
Functional capacity will be assessed using the 6-minute walk test (6MWT). The total distance walked during 6 minutes will be recorded in meters, with greater distances indicating better functional capacity.
Time frame: Baseline, week 6, and week 12
Serum GDF15 concentrations will be measured using an enzyme-linked immunosorbent assay (ELISA) and reported in pg/mL. Changes in GDF15 levels during the supervised aerobic exercise program will be evaluated.
Time frame: Baseline, week 6, and week 12
Serum NF-κB p105 concentrations will be measured using an enzyme-linked immunosorbent assay (ELISA) and reported in ng/mL. Changes in NF-κB p105 levels during the supervised aerobic exercise program will be evaluated.
Time frame: Baseline, week 6, and week 12
Serum visfatin concentrations will be measured using an enzyme-linked immunosorbent assay (ELISA) and reported in ng/mL. Changes in visfatin levels during the supervised aerobic exercise program will be evaluated.
Time frame: Baseline, week 6, and week 12
Perceived cognitive abilities will be assessed using the Perceived Cognitive Abilities (CogPCA) subscale of the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog). Higher scores indicate better perceived cognitive abilities.
Time frame: Baseline, week 6, and week 12
Perceived cognitive impairments will be assessed using the Perceived Cognitive Impairments (CogPCI) subscale of the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog). Higher scores indicate better perceived cognitive function and fewer cognitive difficulties.
Time frame: Baseline, week 6, and week 12
Quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Scores are transformed to a 0-100 scale. Higher scores on the global health status and functional scales indicate better functioning or quality of life, whereas higher scores on symptom scales indicate greater symptom burden.
Gazi University
Other
Evaluation of the Effects of Aerobic Exercise on Metabolic Biomarkers (NF-κB, Visfatin, and GDF15) and Quality of Life in Women With Breast Cancer
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