Effects of Supervised Aerobic Exercise on Biomarkers, Physical Function, and Quality of Life in Breast Cancer Survivors

NCT07798492 | Active Not Recruiting

• 1 other identifier: June 12, 2026, 022
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Breast Cancer; Breast Cancer Survivor; Aerobic Exercise

Keywords

Breast cancer; Quality of Life; Cognitive Function; GDF15; NF-κB p105; Visfatin; Aerobic Exercise; Breast Cancer Survivors

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Baseline, week 6, and week 12

Secondary Outcomes (3)

• Perceived Cognitive Abilities Assessed by the FACT-Cog

  Baseline, week 6, and week 12

• Perceived Cognitive Impairments

  Baseline, week 6, and week 12

• Quality of Life Assessed by the EORTC QLQ-C30

  Baseline, week 6, and week 12

Study Arms (1)

Supervised Aerobic Exercise

EXPERIMENTAL

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

Interventions

Supervised Aerobic Exercise Program BEHAVIORAL

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.

Supervised Aerobic Exercise

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gazi University: lead

Study Sites (2)

Ankara Yildirim Beyazit University

Ankara, Turkey (Türkiye)

Location

Gazi University

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: August 27, 2026
• First Posted: September 1, 2026
• Study Start: June 15, 2026
• Primary Completion: October 1, 2026
• Study Completion: October 1, 2026
• Last Updated: September 1, 2026

Record last verified: 2026-08

Locations

TU (2)