Effects of Exercise Oncology Intervention in Fitness Capacity and Body Composition in Breast Cancer Survivals

NCT05882578 | Completed

• 1 other identifier: WIM_SURVIVALS_22
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this interventional study is to analyze the impact of a supervised oncological exercise intervention in surviving breast cancer patients. The main questions it aims to answer are:

• Evaluate the efectivity of a supervised individualized and adapted oncological physical exercise program in the cardiovascular fitness of the participants.
• Analyze the impact of this intervention in the body composition, functionality and quality of life of the parcitipants Participants will perform a controlled and adapted program, supervised by an especialized professional during 16 weeks. Researchers will compare this intervention group, where the supervised program will take place, with a control group, where the patients will perform regular physical activity (non-supervised) to see the changes in the efectivity and impact in cardiovascular fitness, body composition and quality of life.

Conditions

Breast Cancer; Cancer Survivors

Keywords

Breast Cancer; Exercise Oncology; Cancer Survivors; Fitness Capacity; Quality of life

Outcome Measures

Primary Outcomes (1)

• Cardiovascular fitness

  Evaluate the effectiveness of the program in the improvement of the cardiovascular capacity in breast cancer survivors (looking for a difference of 3,49 ml/kg/min of oxigen consumption), using a submaximal cardiovascular test.

  16 weeks

Secondary Outcomes (7)

• Body composition

  16 weeks

• Physical functionality

  16 weeks

• Exercise adherence

  16 weeks

• Physical activity Levels

  16 weeks

• Fatigue levels

  16weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL

Patients will be assessed and screened prior the intervention. After the physical assestment they will attend 2 days a week for the supervised, and controlled sessions of physical exercise, performed in the nature (Retiro park in Madrid). To meassure the intensity of the program, they will use the 1-10 Borg ratio of perceived exertion (RPE).

Other: Oncological physical exercise intervention

Control Group

ACTIVE COMPARATOR

Patients will be asked to mantain an active lifestyle, performing physical activity regularly.

Other: Active Physical Activities intervention

Interventions

Oncological physical exercise intervention OTHER

An initial physical assestment where clinical history, body composition, functionality, cardiovascular fitness and quality of life will be tested. Patients will be screened and then divided in diferent groups, depending on both their cardiovascular and physical capacity. Then they will perform 2 sessions of combined strength and endurance training per week for 16 weeks. At the end of the training program, the patients will be assesed to evaluate the changes in their cardiovascular fitness, functionality, body composition and quality of life.

Intervention Group

Active Physical Activities intervention OTHER

An initial physical assestment where clinical history, body composition, functionality, cardiovascular fitness and quality of life will be tested Patients will be suggested to mantain active physical activities in their daily life. At the end of the training program, the patients will be assesed to evaluate the changes in their cardiovascular fitness, functionality, body composition and quality of life.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women diagnosed with primary, type I to III A/B cancer, with hormonal positive (ER+ and PG+), triple positive (ER+, PG+ y HER2+) or triple negative subtype.
• Women with chemotherapy and radiotherapy phase complete.
• Women with post-surgery phase complete.
• Women that are within 5 years from diagnostic.
• ECOG Score above or equal to 0 or 1.

You may not qualify if:

• Submit medical contraindications to physical exercise by their reference doctor.
• Women in state IV o methastasis.
• Pregnant women.
• Meet any of the criteria of the American Thoracic Society (ATS) to perfrom a cardiovascular fitness test.

Sponsors & Collaborators

• Tigers Running Club: lead

Study Sites (1)

Tigers Running Club

Madrid, 28009, Spain

Location

Related Publications (24)

• Runowicz CD, Leach CR, Henry NL, Henry KS, Mackey HT, Cowens-Alvarado RL, Cannady RS, Pratt-Chapman ML, Edge SB, Jacobs LA, Hurria A, Marks LB, LaMonte SJ, Warner E, Lyman GH, Ganz PA. American Cancer Society/American Society of Clinical Oncology Breast Cancer Survivorship Care Guideline. CA Cancer J Clin. 2016 Jan-Feb;66(1):43-73. doi: 10.3322/caac.21319. Epub 2015 Dec 7.

  PMID: 26641959 BACKGROUND

• Wang H, Mao X. Evaluation of the Efficacy of Neoadjuvant Chemotherapy for Breast Cancer. Drug Des Devel Ther. 2020 Jun 18;14:2423-2433. doi: 10.2147/DDDT.S253961. eCollection 2020.

  PMID: 32606609 BACKGROUND

• Fisusi FA, Akala EO. Drug Combinations in Breast Cancer Therapy. Pharm Nanotechnol. 2019;7(1):3-23. doi: 10.2174/2211738507666190122111224.

  PMID: 30666921 BACKGROUND

• Nicolazzi MA, Carnicelli A, Fuorlo M, Scaldaferri A, Masetti R, Landolfi R, Favuzzi AMR. Anthracycline and trastuzumab-induced cardiotoxicity in breast cancer. Eur Rev Med Pharmacol Sci. 2018 Apr;22(7):2175-2185. doi: 10.26355/eurrev_201804_14752.

  PMID: 29687878 BACKGROUND

• Minotti G, Menna P, Salvatorelli E, Cairo G, Gianni L. Anthracyclines: molecular advances and pharmacologic developments in antitumor activity and cardiotoxicity. Pharmacol Rev. 2004 Jun;56(2):185-229. doi: 10.1124/pr.56.2.6.

  PMID: 15169927 BACKGROUND

• Kotamraju S, Chitambar CR, Kalivendi SV, Joseph J, Kalyanaraman B. Transferrin receptor-dependent iron uptake is responsible for doxorubicin-mediated apoptosis in endothelial cells: role of oxidant-induced iron signaling in apoptosis. J Biol Chem. 2002 May 10;277(19):17179-87. doi: 10.1074/jbc.M111604200. Epub 2002 Feb 20.

  PMID: 11856741 BACKGROUND

• Bikiewicz A, Banach M, von Haehling S, Maciejewski M, Bielecka-Dabrowa A. Adjuvant breast cancer treatments cardiotoxicity and modern methods of detection and prevention of cardiac complications. ESC Heart Fail. 2021 Aug;8(4):2397-2418. doi: 10.1002/ehf2.13365. Epub 2021 May 5.

  PMID: 33955207 BACKGROUND

• Padegimas A, Clasen S, Ky B. Cardioprotective strategies to prevent breast cancer therapy-induced cardiotoxicity. Trends Cardiovasc Med. 2020 Jan;30(1):22-28. doi: 10.1016/j.tcm.2019.01.006. Epub 2019 Jan 29.

  PMID: 30745071 BACKGROUND

• Cardinale D, Iacopo F, Cipolla CM. Cardiotoxicity of Anthracyclines. Front Cardiovasc Med. 2020 Mar 18;7:26. doi: 10.3389/fcvm.2020.00026. eCollection 2020.

  PMID: 32258060 BACKGROUND

• Armenian SH, Xu L, Ky B, Sun C, Farol LT, Pal SK, Douglas PS, Bhatia S, Chao C. Cardiovascular Disease Among Survivors of Adult-Onset Cancer: A Community-Based Retrospective Cohort Study. J Clin Oncol. 2016 Apr 1;34(10):1122-30. doi: 10.1200/JCO.2015.64.0409. Epub 2016 Feb 1.

  PMID: 26834065 BACKGROUND

• Abdel-Qadir H, Austin PC, Lee DS, Amir E, Tu JV, Thavendiranathan P, Fung K, Anderson GM. A Population-Based Study of Cardiovascular Mortality Following Early-Stage Breast Cancer. JAMA Cardiol. 2017 Jan 1;2(1):88-93. doi: 10.1001/jamacardio.2016.3841.

  PMID: 27732702 BACKGROUND

• Cardinale D, Colombo A, Bacchiani G, Tedeschi I, Meroni CA, Veglia F, Civelli M, Lamantia G, Colombo N, Curigliano G, Fiorentini C, Cipolla CM. Early detection of anthracycline cardiotoxicity and improvement with heart failure therapy. Circulation. 2015 Jun 2;131(22):1981-8. doi: 10.1161/CIRCULATIONAHA.114.013777. Epub 2015 May 6.

  PMID: 25948538 BACKGROUND

• Jones LW, Eves ND, Haykowsky M, Freedland SJ, Mackey JR. Exercise intolerance in cancer and the role of exercise therapy to reverse dysfunction. Lancet Oncol. 2009 Jun;10(6):598-605. doi: 10.1016/S1470-2045(09)70031-2.

  PMID: 19482248 BACKGROUND

• Hurria A, Jones L, Muss HB. Cancer Treatment as an Accelerated Aging Process: Assessment, Biomarkers, and Interventions. Am Soc Clin Oncol Educ Book. 2016;35:e516-22. doi: 10.1200/EDBK_156160.

  PMID: 27249761 BACKGROUND

• Jones LW, Courneya KS, Mackey JR, Muss HB, Pituskin EN, Scott JM, Hornsby WE, Coan AD, Herndon JE 2nd, Douglas PS, Haykowsky M. Cardiopulmonary function and age-related decline across the breast cancer survivorship continuum. J Clin Oncol. 2012 Jul 10;30(20):2530-7. doi: 10.1200/JCO.2011.39.9014. Epub 2012 May 21.

  PMID: 22614980 BACKGROUND

• Adams MJ, Lipsitz SR, Colan SD, Tarbell NJ, Treves ST, Diller L, Greenbaum N, Mauch P, Lipshultz SE. Cardiovascular status in long-term survivors of Hodgkin's disease treated with chest radiotherapy. J Clin Oncol. 2004 Aug 1;22(15):3139-48. doi: 10.1200/JCO.2004.09.109.

  PMID: 15284266 BACKGROUND

• Foulkes SJ, Howden EJ, Bigaran A, Janssens K, Antill Y, Loi S, Claus P, Haykowsky MJ, Daly RM, Fraser SF, LA Gerche A. Persistent Impairment in Cardiopulmonary Fitness after Breast Cancer Chemotherapy. Med Sci Sports Exerc. 2019 Aug;51(8):1573-1581. doi: 10.1249/MSS.0000000000001970.

  PMID: 30829962 BACKGROUND

• Brubaker P, Jensen A, Jordan J, Lamar Z, Mihalko S, Haykowsky M, Jones L, D Agostino R Jr, Kitzman D, Reding K, Hundley WG. Exercise Capacity Is Reduced in Cancer Survivors Previously Treated With Anthracycline-Based Chemotherapy Despite a Preserved Cardiac Output Response. JACC Cardiovasc Imaging. 2019 Nov;12(11 Pt 1):2267-2269. doi: 10.1016/j.jcmg.2019.05.016. Epub 2019 Jul 17. No abstract available.

  PMID: 31326490 BACKGROUND

• Groarke JD, Payne DL, Claggett B, Mehra MR, Gong J, Caron J, Mahmood SS, Hainer J, Neilan TG, Partridge AH, Di Carli M, Jones LW, Nohria A. Association of post-diagnosis cardiorespiratory fitness with cause-specific mortality in cancer. Eur Heart J Qual Care Clin Outcomes. 2020 Oct 1;6(4):315-322. doi: 10.1093/ehjqcco/qcaa015.

  PMID: 32167560 BACKGROUND

• Bortolozo HI, Derchain S, Vechin FC, Maginador GF, Santos IS, Torresan R, de Nazare Silva Dos Santos P, Sarian LO, Conceicao MS. Aerobic Fitness is a Predictor of Body Composition in Women With Breast Cancer at Diagnosis. Clin Breast Cancer. 2021 Jun;21(3):e245-e251. doi: 10.1016/j.clbc.2020.10.001. Epub 2020 Oct 9.

  PMID: 34159902 BACKGROUND

• Kirkham AA, Bland KA, Sayyari S, Campbell KL, Davis MK. Clinically Relevant Physical Benefits of Exercise Interventions in Breast Cancer Survivors. Curr Oncol Rep. 2016 Feb;18(2):12. doi: 10.1007/s11912-015-0496-3.

  PMID: 26769117 BACKGROUND

• Schmidt T, van Mackelenbergh M, Wesch D, Mundhenke C. Physical activity influences the immune system of breast cancer patients. J Cancer Res Ther. 2017 Jul-Sep;13(3):392-398. doi: 10.4103/0973-1482.150356.

  PMID: 28862198 BACKGROUND

• Leclerc AF, Foidart-Dessalle M, Tomasella M, Coucke P, Devos M, Bruyere O, Bury T, Deflandre D, Jerusalem G, Lifrange E, Kaux JF, Crielaard JM, Maquet D. Multidisciplinary rehabilitation program after breast cancer: benefits on physical function, anthropometry and quality of life. Eur J Phys Rehabil Med. 2017 Oct;53(5):633-642. doi: 10.23736/S1973-9087.17.04551-8. Epub 2017 Mar 20.

  PMID: 28322035 BACKGROUND

• Demark-Wahnefried W, Rogers LQ, Gibson JT, Harada S, Fruge AD, Oster RA, Grizzle WE, Norian LA, Yang ES, Della Manna D, Jones LW, Azrad M, Krontiras H. Randomized trial of weight loss in primary breast cancer: Impact on body composition, circulating biomarkers and tumor characteristics. Int J Cancer. 2020 May 15;146(10):2784-2796. doi: 10.1002/ijc.32637. Epub 2019 Sep 5.

  PMID: 31442303 BACKGROUND

Related Links

• Figures of cancer incidence, prevalence, mortality, survival and risk factors in Spain

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Soraya Casla-Barrio, PhD

  Tigers Running Club

  PRINCIPAL INVESTIGATOR

• Helios Pareja-Galeano, PhD

  Universidad Autonoma de Madrid

  STUDY CHAIR

• Mónica Castellanos, MSc

  Tigers Running Club

  STUDY CHAIR

• Jaime Pérez-Vélez, BSc

  Tigers Running Club

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Doesn´t exist. Patients were allocated depending their preferences
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Oncologic Physical Exercise Area and PhD in Exercise Psychology

Model Details: control trial

Study Record Dates

• First Submitted: May 22, 2023
• First Posted: May 31, 2023
• Study Start: January 12, 2023
• Primary Completion: April 9, 2023
• Study Completion: July 31, 2023
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)