Breast CancerNCT07798492
Effects of Supervised Aerobic Exercise on Biomarkers, Physical Function, and Quality of Life in Breast Cancer Survivors
A study testing Supervised Aerobic Exercise Program in people with Breast Cancer and Breast Cancer Survivor, run by Gazi University at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer, Breast Cancer Survivor, Aerobic Exercise
- What is being tested?
- Supervised Aerobic Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 15 Jun 2026to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Ankara Yildirim Beyazit University
Ankara
Gazi University
Ankara
About this study
Official title: Evaluation of the Effects of Aerobic Exercise on Metabolic Biomarkers (NF-κB, Visfatin, and GDF15) and Quality of Life in Women With Breast Cancer
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
- Being tested
- Supervised Aerobic Exercise Program
- Keywords
- Breast cancer, Quality of Life, Cognitive Function, GDF15, NF-κB p105, Visfatin, Aerobic Exercise, Breast Cancer Survivors
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised Aerobic Exercise ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Supervised Aerobic Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, week 6, and week 12
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline, week 6, and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start15 Jun 2026
- Primary completion1 Oct 2026
- Study completion1 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kubranur UNAL, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07798492
- Sponsor's protocol ID
- June 12, 2026, 022
- Status last verified
- Aug 2026
- First submitted
- 27 Aug 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-identified individual participant data may be available from the corresponding author upon reasonable request, subject to appropriate ethical and institutional approval.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Aerobic Exercise on Metabolic Biomarkers (NF-κB, Visfatin, and GDF15) and Quality of Life in Women With Breast Cancer
- ClinicalTrials.gov ID
- NCT07798492
- Acronym / sponsor ID
- June 12, 2026, 022
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 15 Jun 2026 (actual)
- Primary completion
- 1 Oct 2026 (actual)
- Study completion
- 1 Oct 2026 (actual)
- First posted
- 1 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supervised Aerobic Exercise | Experimental | Behavioral: Supervised Aerobic Exercise ProgramParticipants assigned to this arm will complete a 12-week supervised aerobic exercise program. Assessments will be performed at baseline, week 6, and week 12. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supervised Aerobic Exercise ProgramParticipants 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. | Behavioural | Supervised Aerobic Exercise |
Primary outcome
Functional Capacity Assessed by the 6-Minute Walk Test
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.
Serum Growth Differentiation Factor 15 (GDF15) Level
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.
Serum Nuclear Factor Kappa B p105 (NF-κB p105) Level
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.
Serum Visfatin Level
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.
3 secondary outcomes
Perceived Cognitive Abilities Assessed by the FACT-Cog
Time frame: Baseline, week 6, and week 12
Perceived Cognitive Impairments
Time frame: Baseline, week 6, and week 12
Quality of Life Assessed by the EORTC QLQ-C30
Time frame: Baseline, week 6, and week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: Undecided. De-identified individual participant data may be available from the corresponding author upon reasonable request, subject to appropriate ethical and institutional approval.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised Aerobic Exercise Program in people with Breast Cancer and Breast Cancer Survivor, run by Gazi University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Capacity Assessed by the 6-Minute Walk Test (time frame: Baseline, week 6, and week 12). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.