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Breast Cancer FemaleNCT06540612

Effects of Aerobic Exercise on Cancer-Related Biomarkers, Functional Capacity, Cognitive Status and Quality of Life in Women With Breast Cancer

A study testing Aerobic exercise and Physical activity counseling in people with Breast Cancer Female and Quality of Life, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years, women only
What is being tested?
Aerobic exercise and Physical activity counseling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
69 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 May 2024to 15 Apr 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

  • Patients aged between 18 and 65
  • Literate
  • Diagnosed with stage 2 breast cancer
  • Completed primary breast cancer treatment at least 6 months ago (excluding hormone therapy/aromatase inhibitors)
  • Provided cooperation
  • Female
  • Patients who are willing and willing to participate in the study

Who cannot join

  • Those who are using psychotic, anxiolytic, antidepressant, analgesic and sleeping pills
  • Those with metastasis
  • Those with a history of lymphedema
  • Those with neurological disease
  • Those who are pregnant or breastfeeding
  • Uncontrolled hypertensive patients
  • Those who are incapable of verbal communication or physical movement

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Nahide FIDANCIOGLU

    Yenimahalle, Ankara

Other trials in Turkey (Türkiye)

About this study

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.

Read more

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.

Read the detailed description

Breast cancer is the most common malignant tumor in women with a rate of 30%. Again, 15% of cancer-related deaths in women are due to breast cancer. Breast cancer, whose incidence among women is increasing in our country, is seen in one out of every four women diagnosed with cancer. Approximately one in every eight women is at lifelong risk of developing breast cancer (Turkish Society of Medical Oncology Breast Cancer, 2019).

As a side effect of the disease and multimodal anticancer interventions, breast cancer patients may experience cancer-related physical and psychological symptoms such as cancer-related fatigue, decreased muscle mass, loss of strength, decreased functional capacity, and pain. These symptoms create a vicious cycle leading to deterioration in quality of life. Oncological rehabilitation aims to reduce such symptoms through multimodal, transprofessionally delivered, goal-oriented and person-centered coordinated interventions. Oncological rehabilitation is available before, during, between and after cancer treatments.

Inflammation is the hallmark of cancer and is associated with poor clinical outcomes in patients with various types of solid tumors. Inflammation activates certain signaling pathways to promote cell survival, proliferation, migration and invasion. Preclinical studies show that reducing inflammation and targeting inflammatory signaling pathways slows cell growth and delays tumor progression. Furthermore, obesity causes chronic inflammation that can promote malignant cell growth. The anti-inflammatory benefit of aerobic exercise may arise in part due to a reduction in adiposity.

Decreased immune function often accompanies anti-cancer therapies and reduces overall quality of life. Compromised chronic inflammation and cellular immunity are major concerns, as both promote a pro-tumor environment that may contribute to disease progression. Therefore, there is a need to identify options to manage inflammation while maximizing immune function in cancer survivorship. Exercise is a potentially attractive option. However, the role of exercise training on immune function and inflammatory markers is not well addressed in current exercise oncology guidelines.

Immune cell rates and function provide direct evidence of immunity in cancer survivors. Cytokines are often categorized as pro- or anti-inflammatory; some function as both (such as interleukin-6). Higher circulating levels of pro-inflammatory cytokines are linked to cancer-related outcomes. For example, breast cancer patients with advanced tumors have higher circulating levels of tumor necrosis factor (TNF) compared with healthy individuals. Previous systematic reviews had concluded that exercise training had no effect on circulating cytokines in cancer survivors overall. However, a recent meta-analysis using a more homogeneous population reported positive effects of TNF, interleukin-6, interleukin-8 and interleukin-2 in breast cancer. Despite the role of the inflammatory state in various cancers and the growing body of literature examining cytokines in exercise oncology, it remains unclear whether the benefits of exercise extend beyond breast cancer.

Being tested
Aerobic exercise, Physical activity counseling
Keywords
Breast Cancer, Rehabilitation, Biomarkers, Exercise
Medical subject headings
Breast Neoplasms, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aerobic exerciseOther

    Aerobic exercise is a set of physical activities that work large muscle groups continuously and rhythmically.

  • Physical activity counselingBehavioural

    Physical activity counselling is a service that provides personalized guidance and support to help individuals adopt a healthy lifestyle.

Study groups in NCT06540612
Study groupRoleWhat they receive
Aerobic Exercise InterventionExperimentalIn this group, participants do moderate-intensity aerobic exercise three days a week.
Receives: Other: Aerobic exercise
Physical activity counselingActive comparatorRealistic and achievable goals are set based on the individual's needs and goals. An individualized exercise program is created. This program may include aerobic exercise, strength training, flexibility exercises, and other activities. The individual is educated about proper techniques, safe practices, and benefits of the exercises. The individual's progress is monitored and evaluated regularly, and adjustments to the program are made as needed. Ongoing support and encouragement is provided to help the individual stay motivated and achieve their goals.
Receives: Behavioral: Physical activity counseling
control groupNo interventionThe control group continued their current daily activities and did not perform any new exercise program.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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 outcomes (1)
  1. 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.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2024
  2. Study start15 May 2024
  3. Primary completion1 Jun 2025
  4. Study completion15 Apr 2026

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
69 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06540612
Sponsor's protocol ID
TABED 1-24-82
Status last verified
Sep 2025
First submitted
2 Aug 2024
Last updated
13 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020 Jan;70(1):7-30. doi: 10.3322/caac.21590. Epub 2020 Jan 8.

    PubMed 31912902
  • Asher A, Myers JS. The effect of cancer treatment on cognitive function. Clin Adv Hematol Oncol. 2015 Jul;13(7):441-50.

    PubMed 26353040
  • Erratum: ATS Statement: Guidelines for the Six-Minute Walk Test. Am J Respir Crit Care Med. 2016 May 15;193(10):1185. doi: 10.1164/rccm.19310erratum. No abstract available.

    PubMed 27174486
  • Aggarwal BB, Gehlot P. Inflammation and cancer: how friendly is the relationship for cancer patients? Curr Opin Pharmacol. 2009 Aug;9(4):351-69. doi: 10.1016/j.coph.2009.06.020. Epub 2009 Aug 6.

    PubMed 19665429
  • Furman D, Campisi J, Verdin E, Carrera-Bastos P, Targ S, Franceschi C, Ferrucci L, Gilroy DW, Fasano A, Miller GW, Miller AH, Mantovani A, Weyand CM, Barzilai N, Goronzy JJ, Rando TA, Effros RB, Lucia A, Kleinstreuer N, Slavich GM. Chronic inflammation in the etiology of disease across the life span. Nat Med. 2019 Dec;25(12):1822-1832. doi: 10.1038/s41591-019-0675-0. Epub 2019 Dec 5.

    PubMed 31806905
  • Iyengar NM, Gucalp A, Dannenberg AJ, Hudis CA. Obesity and Cancer Mechanisms: Tumor Microenvironment and Inflammation. J Clin Oncol. 2016 Dec 10;34(35):4270-4276. doi: 10.1200/JCO.2016.67.4283. Epub 2016 Nov 7.

    PubMed 27903155
  • Bower JE, Greendale G, Crosswell AD, Garet D, Sternlieb B, Ganz PA, Irwin MR, Olmstead R, Arevalo J, Cole SW. Yoga reduces inflammatory signaling in fatigued breast cancer survivors: a randomized controlled trial. Psychoneuroendocrinology. 2014 May;43:20-9. doi: 10.1016/j.psyneuen.2014.01.019. Epub 2014 Jan 30.

    PubMed 24703167
  • Johnson DE, O'Keefe RA, Grandis JR. Targeting the IL-6/JAK/STAT3 signalling axis in cancer. Nat Rev Clin Oncol. 2018 Apr;15(4):234-248. doi: 10.1038/nrclinonc.2018.8. Epub 2018 Feb 6.

    PubMed 29405201
  • Zomkowski K, Wittkopf PG, Baungarten Hugen Back B, Bergmann A, Dias M, Sperandio FF. Pain characteristics and quality of life of breast cancer survivors that return and do not return to work: an exploratory cross-sectional study. Disabil Rehabil. 2021 Dec;43(26):3821-3826. doi: 10.1080/09638288.2020.1759150. Epub 2020 May 12.

    PubMed 32393077
  • Khosravi N, Stoner L, Farajivafa V, Hanson ED. Exercise training, circulating cytokine levels and immune function in cancer survivors: A meta-analysis. Brain Behav Immun. 2019 Oct;81:92-104. doi: 10.1016/j.bbi.2019.08.187. Epub 2019 Aug 24.

    PubMed 31454519
  • Kokkonen K, Saarto T, Makinen T, Pohjola L, Kautio H, Jarvenpaa S, Puustjarvi-Sunabacka K. The functional capacity and quality of life of women with advanced breast cancer. Breast Cancer. 2017 Jan;24(1):128-136. doi: 10.1007/s12282-016-0687-2. Epub 2016 Mar 22.

    PubMed 27002988
  • Al Maqbali M, Al Sinani M, Al Naamani Z, Al Badi K, Tanash MI. Prevalence of Fatigue in Patients With Cancer: A Systematic Review and Meta-Analysis. J Pain Symptom Manage. 2021 Jan;61(1):167-189.e14. doi: 10.1016/j.jpainsymman.2020.07.037. Epub 2020 Aug 5.

    PubMed 32768552
  • Mantovani A, Allavena P, Sica A, Balkwill F. Cancer-related inflammation. Nature. 2008 Jul 24;454(7203):436-44. doi: 10.1038/nature07205.

    PubMed 18650914
  • Klassen O, Schmidt ME, Ulrich CM, Schneeweiss A, Potthoff K, Steindorf K, Wiskemann J. Muscle strength in breast cancer patients receiving different treatment regimes. J Cachexia Sarcopenia Muscle. 2017 Apr;8(2):305-316. doi: 10.1002/jcsm.12165. Epub 2016 Nov 28.

    PubMed 27896952

Questions about this trial

What is this clinical trial studying?

A study testing Aerobic exercise and Physical activity counseling in people with Breast Cancer Female and Quality of Life, run by Hasan Kalyoncu University at 1 site 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 7 inclusion and 7 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 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Quality Of Life Questionnaire (time frame: 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06540612, which also lists 14 linked publications.

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 13 May 2026.

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