An interventional study of Supervised Aerobic Exercise Program in Breast Cancer, Breast Cancer Survivor and Aerobic Exercise, sponsored by Gazi University. Active, not recruiting at 2 sites in Turkey (Türkiye). Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by Gazi University · Not applicable, Interventional, and Supportive care
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.
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 assigned to this arm will complete a 12-week supervised aerobic exercise program. Assessments will be performed at baseline, week 6, and week 12.
Behavioral: Supervised Aerobic Exercise Program
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.
Functional Capacity Assessed by the 6-Minute Walk Test
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 Growth Differentiation Factor 15 (GDF15) Level
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 Nuclear Factor Kappa B p105 (NF-κB p105) Level
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 Level
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 Assessed by the FACT-Cog
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
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 Assessed by the EORTC QLQ-C30
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.
Time frame: Baseline, week 6, and week 12
Plan to share: Undecided — De-identified individual participant data may be available from the corresponding author upon reasonable request, subject to appropriate ethical and institutional approval.
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Gazi University