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

NCT06540612 | Enrolling By Invitation DMC

• 1 other identifier: TABED 1-24-82
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief 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 with breast cancer in remission period. The women who will participate in the study consist of breast cancer survivors aged 18-65 years. 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.

Conditions

Breast Cancer Female; Quality of Life; Survivorship

Keywords

Breast Cancer; Rehabilitation; Biomarkers; Exercise

Outcome Measures

Primary Outcomes (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.

  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)

• Functional Capacity

  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.

Other Outcomes (2)

• Cognitive Status

  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.

• Biomarkers(CRP, IGF-1, insulin, leptin, IL-6, TNF-α, adiponectin)

  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.

Study Arms (3)

Aerobic Exercise Intervention

EXPERIMENTAL

In this group, participants do moderate-intensity aerobic exercise three days a week.

Other: Aerobic exercise

Physical activity counseling

ACTIVE COMPARATOR

Realistic 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.

Behavioral: Physical activity counseling

control group

NO INTERVENTION

The control group continued their current daily activities and did not perform any new exercise program.

Interventions

Aerobic exercise OTHER

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

Aerobic Exercise Intervention

Physical activity counseling BEHAVIORAL

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

Physical activity counseling

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hasan Kalyoncu University: lead

Study Sites (1)

Nahide FIDANCIOGLU

Yenimahalle, Ankara, Turkey (Türkiye)

Location

Related Publications (14)

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  PMID: 26353040 RESULT

• 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.

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• 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.

  PMID: 31806905 RESULT

• 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.

  PMID: 27903155 RESULT

• 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.

  PMID: 24703167 RESULT

• 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.

  PMID: 29405201 RESULT

• 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.

  PMID: 32393077 RESULT

• 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.

  PMID: 31454519 RESULT

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  PMID: 27002988 RESULT

• 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.

  PMID: 32768552 RESULT

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  PMID: 18650914 RESULT

• 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.

  PMID: 27896952 RESULT

Related Links

• EORTC QLQ-C30 Scoring Manual
• Breast Cancer

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Nahide Fidancıoğlu

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Study Record Dates

• First Submitted: August 2, 2024
• First Posted: August 6, 2024
• Study Start: May 15, 2024
• Primary Completion: June 1, 2025
• Study Completion: August 15, 2025
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)