Supervised Physical Activity in Young Women With Early Breast Cancer During Neoadjuvant Chemotherpy

Summary

The main goal of this study is to assess the impact of supervised intense physical activity (IPA) on outcomes of neoadjuvant chemotherapy in young women with breast cancer (YWBC). In this project standard neoadjuvant chemotherapy will be used concordant with summary of product characteristics (SPC). However during treatment (including days of chemotherapy application) an additional modifier of therapy will be carried out in the form of intense physical activity. This strategy is not recognized in SPC. This project aims to improve the results of breast cancer treatment in young women. According to available data, nowadays this subset of breast cancer patients has worse therapy results in comparison to older women. This is partially because of the different tumor characteristics; young women are more likely to present with human epithelial growth factor receptor 2 (HER2) receptor overexpression or with triple negative breast cancer. In the treatment of YWBC, preoperative chemotherapy is most often the first step. This enables the opportunity to assess the effectiveness of additional interventions in a mode it was never tested before. It is believed that physical activity improves the results of breast cancer treatment, however there are only few reports describing its benefit and role in terms of preoperative chemotherapy. In the current project, the investigators planned to introduce supervised increased physical activity concurrently with neoadjuvant treatment in YWBC at early stage of disease. The main goal of the study is to assess the effect of physical activity on preoperative chemotherapy outcomes. The change of tumor size after neoadjuvant chemotherapy, as well as the impact on Quality of Life (QoL) and Patients' Reported Outcome (PRO) in described above treatment modality. Secondary endpoints are the following: the pathologic Complete Response (pCR), disease free survival after 3 years (3-yr DFS), overall survival (OS), cardiotoxicity of treatment, the effect of physical activity on tumor microenvironment and Ki67 as well as the impact of increased physical activity on further patients' lifestyle changes.

Timeline

Start

2018-10-11

Primary completion

2020-03-31

Completion

2026-12-31

Publications

• Background Cardoso F, Kyriakides S, Ohno S, Penault-Llorca F, Poortmans P, Rubio IT, Zackrisson S, Senkus E; ESMO Guidelines Committee. Early breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2019 Oct 1;30(10):1674. doi: 10.1093/annonc/mdz189. No abstract available.
• Background Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Increasing the dose intensity of chemotherapy by more frequent administration or sequential scheduling: a patient-level meta-analysis of 37 298 women with early breast cancer in 26 randomised trials. Lancet. 2019 Apr 6;393(10179):1440-1452. doi: 10.1016/S0140-6736(18)33137-4. Epub 2019 Feb 8.
• Background Gianni L, Pienkowski T, Im YH, Tseng LM, Liu MC, Lluch A, Staroslawska E, de la Haba-Rodriguez J, Im SA, Pedrini JL, Poirier B, Morandi P, Semiglazov V, Srimuninnimit V, Bianchi GV, Magazzu D, McNally V, Douthwaite H, Ross G, Valagussa P. 5-year analysis of neoadjuvant pertuzumab and trastuzumab in patients with locally advanced, inflammatory, or early-stage HER2-positive breast cancer (NeoSphere): a multicentre, open-label, phase 2 randomised trial. Lancet Oncol. 2016 Jun;17(6):791-800. doi: 10.1016/S1470-2045(16)00163-7. Epub 2016 May 11.
• Background Cardoso F, Harbeck. Breast cancer in young women-a clinical challenge to be addressed in a multidisciplinary setting. Breast Care 2012; 7:193-194
• Background Liedtke C, Hess KR, Karn T, Rody A, Kiesel L, Hortobagyi GN, Pusztai L, Gonzalez-Angulo AM. The prognostic impact of age in patients with triple-negative breast cancer. Breast Cancer Res Treat. 2013 Apr;138(2):591-9. doi: 10.1007/s10549-013-2461-x. Epub 2013 Mar 5.
• Background Jones LW, Alfano CM. Exercise-oncology research: past, present, and future. Acta Oncol. 2013 Feb;52(2):195-215. doi: 10.3109/0284186X.2012.742564. Epub 2012 Dec 17.
• Background Bolam KA, Mijwel S, Rundqvist H, Wengstrom Y. Two-year follow-up of the OptiTrain randomised controlled exercise trial. Breast Cancer Res Treat. 2019 Jun;175(3):637-648. doi: 10.1007/s10549-019-05204-0. Epub 2019 Mar 26.
• Background Loughney L, West MA, Kemp GJ, Grocott MP, Jack S. Exercise intervention in people with cancer undergoing neoadjuvant cancer treatment and surgery: A systematic review. Eur J Surg Oncol. 2016 Jan;42(1):28-38. doi: 10.1016/j.ejso.2015.09.027. Epub 2015 Oct 23.
• Background Mugele H, Freitag N, Wilhelmi J, Yang Y, Cheng S, Bloch W, Schumann M. High-intensity interval training in the therapy and aftercare of cancer patients: a systematic review with meta-analysis. J Cancer Surviv. 2019 Apr;13(2):205-223. doi: 10.1007/s11764-019-00743-3. Epub 2019 Feb 26.
• Background West MA, Loughney L, Barben CP, Sripadam R, Kemp GJ, Grocott MP, Jack S. The effects of neoadjuvant chemoradiotherapy on physical fitness and morbidity in rectal cancer surgery patients. Eur J Surg Oncol. 2014 Nov;40(11):1421-8. doi: 10.1016/j.ejso.2014.03.021. Epub 2014 Apr 12.
• Background Betof AS, Lascola CD, Weitzel D, Landon C, Scarbrough PM, Devi GR, Palmer G, Jones LW, Dewhirst MW. Modulation of murine breast tumor vascularity, hypoxia and chemotherapeutic response by exercise. J Natl Cancer Inst. 2015 Mar 16;107(5):djv040. doi: 10.1093/jnci/djv040. Print 2015 May.
• Background Dieli-Conwright CM, Orozco BZ. Exercise after breast cancer treatment: current perspectives. Breast Cancer (Dove Med Press). 2015 Oct 21;7:353-62. doi: 10.2147/BCTT.S82039. eCollection 2015.
• Background Saarto T, Sievanen H, Kellokumpu-Lehtinen P, Nikander R, Vehmanen L, Huovinen R, Kautiainen H, Jarvenpaa S, Penttinen HM, Utriainen M, Jaaskelainen AS, Elme A, Ruohola J, Palva T, Vertio H, Rautalahti M, Fogelholm M, Luoto R, Blomqvist C. Effect of supervised and home exercise training on bone mineral density among breast cancer patients. A 12-month randomised controlled trial. Osteoporos Int. 2012 May;23(5):1601-12. doi: 10.1007/s00198-011-1761-4. Epub 2011 Sep 3.
• Background Rugo HS, Ahles T. The impact of adjuvant therapy for breast cancer on cognitive function: current evidence and directions for research. Semin Oncol. 2003 Dec;30(6):749-62. doi: 10.1053/j.seminoncol.2003.09.008.
• Background Salmon P. Effects of physical exercise on anxiety, depression, and sensitivity to stress: a unifying theory. Clin Psychol Rev. 2001 Feb;21(1):33-61. doi: 10.1016/s0272-7358(99)00032-x.
• Background Furmaniak AC, Menig M, Markes MH. Exercise for women receiving adjuvant therapy for breast cancer. Cochrane Database Syst Rev. 2016 Sep 21;9(9):CD005001. doi: 10.1002/14651858.CD005001.pub3.
• Background Deshmukh SK, Srivastava SK, Poosarla T, Dyess DL, Holliday NP, Singh AP, Singh S. Inflammation, immunosuppressive microenvironment and breast cancer: opportunities for cancer prevention and therapy. Ann Transl Med. 2019 Oct;7(20):593. doi: 10.21037/atm.2019.09.68.
• Background Theriau CF, Connor MK. Voluntary physical activity counteracts the proliferative tumor growth microenvironment created by adipose tissue via high-fat diet feeding in female rats. Physiol Rep. 2017 Jul;5(13):e13325. doi: 10.14814/phy2.13325.
• Gorecki M, Kufel-Grabowska J, Dudek M, Litwiniuk M, Nowak A, Bartczak-Rutkowska A, Straburzynska-Migaj E, Dos J, Marszalek A, Nowaczyk P, Lembryk M, Piotrowski I, Suchorska W, Lesiak M, Marszalek S. A randomized trial on the feasibility of high-intensity interval training during chemotherapy in young breast cancer patients. Sci Rep. 2025 Oct 28;15(1):37591. doi: 10.1038/s41598-025-18377-0.
• Dudek M, Gorecki M, Marszalek S, Kufel-Grabowska J, Litwiniuk M, Nowak A, Bartczak-Rutkowska A, Dos J, Marszalek A, Nowaczyk P, Lembryk M, Piotrowski I, Rosochowicz MA, Suchorska W, Lesiak M, Straburzynska-Migaj E. Supervised high-intensity interval training reduces the negative effect of chemotherapy on cardiorespiratory fitness in young breast cancer women: a randomised controlled study. Eur J Appl Physiol. 2025 Nov;125(11):3141-3154. doi: 10.1007/s00421-025-05822-1. Epub 2025 Jun 5.

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