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Exercise oncology clinical trials during treatments: a commentary to address the safety concerns of human subjects regulatory reviewers and committees

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Abstract

Exercise oncology clinical trials contribute to the advancement of our scientific knowledge and to the safety and care of patients diagnosed with cancer. Nevertheless, regulatory reviewers and committees may not be familiar with the well-documented long-term health benefits and safety of the regular practice of physical activity. Moreover, they may not see how the benefits outweigh the risks in the context where patients diagnosed with cancer are typically seen as vulnerable. Therefore, we would like to provide a purpose-built overview of exercise oncology clinical trials for members involved in institutional review committees, including the Scientific Review Committee (SRC), the Institutional Review Board (IRB), and the Data Safety Monitoring Committee (DSMC) to facilitate a greater understanding of the safety and benefits of physical activity during cancer treatments. Communication is key to improve the success of exercise oncology clinical trials, which are vital for patients diagnosed with cancer.

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Notes

  1. Exercise professionals are trained exercise physiologists with specialty training in oncology or certified cancer exercise trainers who know and understand the most up-to-date evidence-based oncology clinical practice and best practices related to exercise testing and prescription for patients diagnosed with cancer.

References

  1. Campbell KL, Winters-Stone KM, Wiskemann J, May AM, Schwartz AL, Courneya KS et al (2019) Exercise guidelines for cancer survivors: consensus statement from international multidisciplinary roundtable. Med Sci Sports Exerc 51(11):2375–2390

    Article  PubMed  PubMed Central  Google Scholar 

  2. Schmitz KH, Stout NL, Maitin-Shepard M, Campbell A, Schwartz AL, Grimmett C et al (2021) Moving through cancer: Setting the agenda to make exercise standard in oncology practice. Cancer 127(3):476–484

    Article  PubMed  Google Scholar 

  3. Piercy KL, Troiano RP, Ballard RM, Carlson SA, Fulton JE, Galuska DA et al (2018) The physical activity guidelines for americans. JAMA 320(19):2020–2028

    Article  PubMed  PubMed Central  Google Scholar 

  4. Mokdad AH, Marks JS, Stroup DF, Gerberding JL (2004) Actual causes of death in the United States, 2000. JAMA 291(10):1238–1245

    Article  PubMed  Google Scholar 

  5. Mokdad AH, Marks JS, Stroup DF, Gerberding JL (2005) Correction: actual causes of death in the United States, 2000. JAMA 293(3):293–294

    Article  CAS  PubMed  Google Scholar 

  6. Carlson SA, Fulton JE, Pratt M, Yang Z, Adams EK (2015) Inadequate physical activity and health care expenditures in the United States. Prog Cardiovasc Dis 57(4):315–323

    Article  PubMed  Google Scholar 

  7. Schmitz KH, Courneya KS, Matthews C, Demark-Wahnefried W, Galvão DA, Pinto BM et al (2010) American College of Sports Medicine roundtable on exercise guidelines for cancer survivors. Med Sci Sports Exerc 42(7):1409–1426

    Article  PubMed  Google Scholar 

  8. Ligibel JA, Bohlke K, May AM, Clinton SK, Demark-Wahnefried W, Gilchrist SC et al (2022) Exercise, diet, and weight management during cancer treatment: ASCO guideline. J Clin Oncol 40(22):2491–2507

    Article  PubMed  Google Scholar 

  9. Heywood R, McCarthy AL, Skinner TL (2017) Safety and feasibility of exercise interventions in patients with advanced cancer: a systematic review. Support Care Cancer 25(10):3031–3050

    Article  PubMed  Google Scholar 

  10. Stout NL, Baima J, Swisher AK, Winters-Stone KM, Welsh J (2017) A systematic review of exercise systematic reviews in the cancer literature (2005–2017). PM&R 9(9s2):S347-s84

    Article  Google Scholar 

  11. Segal R, Zwaal C, Green E, Tomasone JR, Loblaw A, Petrella T (2017) Exercise for people with cancer: a clinical practice guideline. Curr Oncol 24(1):40–46

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  12. Cormie P, Zopf EM, Zhang X, Schmitz KH (2017) The impact of exercise on cancer mortality, recurrence, and treatment-related adverse effects. Epidemiol Rev 39(1):71–92

    Article  PubMed  Google Scholar 

  13. Groen WG, Naaktgeboren WR, van Harten WH, van Vulpen JK, Kool N, Sonke GS et al (2022) Physical fitness and chemotherapy tolerance in patients with early-stage breast cancer. Med Sci Sports Exerc 54(4):537–542

  14. Piraux E, Caty G, Aboubakar Nana F, Reychler G (2020) Effects of exercise therapy in cancer patients undergoing radiotherapy treatment: a narrative review. SAGE Open Med 8:2050312120922657

    Article  PubMed  PubMed Central  Google Scholar 

  15. Zaorsky NG, Allenby T, Lin J, Rosenberg J, Simone NL, Schmitz KH (2021) Exercise therapy and radiation therapy for cancer: a systematic review. Int J Radiat Oncol Biol Phys 110(4):973–983

    Article  PubMed  Google Scholar 

  16. Michael CM, Lehrer EJ, Schmitz KH, Zaorsky NG (2021) Prehabilitation exercise therapy for cancer: a systematic review and meta-analysis. Cancer Med 10(13):4195–4205

    Article  PubMed  PubMed Central  Google Scholar 

  17. Potiaumpai M, Doerksen SE, Chinchilli VM, Wu H, Wang L, Lintz R et al (2021) Cost evaluation of an exercise oncology intervention: the exercise in all chemotherapy trial. Cancer Rep 5(3):1490–1497

  18. Schmidt ME, Wiskemann J, Ulrich CM, Schneeweiss A, Steindorf K (2017) Self-reported physical activity behavior of breast cancer survivors during and after adjuvant therapy: 12 months follow-up of two randomized exercise intervention trials. Acta Oncol 56(4):618–627

    Article  PubMed  Google Scholar 

  19. Fassier P, Zelek L, Partula V, Srour B, Bachmann P, Touillaud M et al (2016) Variations of physical activity and sedentary behavior between before and after cancer diagnosis: results from the prospective population-based NutriNet-Santé cohort. Medicine (Baltimore) 95(40):e4629

    Article  PubMed  Google Scholar 

  20. Schmitz KH, Campbell AM, Stuiver MM, Pinto BM, Schwartz AL, Morris GS et al (2019) Exercise is medicine in oncology: engaging clinicians to help patients move through cancer. CA Cancer J Clin 69(6):468–484

    Article  PubMed  PubMed Central  Google Scholar 

  21. Ligibel JA, Jones LW, Brewster AM, Clinton SK, Korde LA, Oeffinger KC et al (2019) Oncologists’ attitudes and practice of addressing diet, physical activity, and weight management with patients with cancer: findings of an ASCO Survey of the Oncology Workforce. J Oncol Pract 15(6):e520–e528

    Article  PubMed  PubMed Central  Google Scholar 

  22. Schmitz KH, Holtzman J, Courneya KS, Mâsse LC, Duval S, Kane R (2005) Controlled physical activity trials in cancer survivors: a systematic review and meta-analysis. Cancer Epidemiol Biomarkers Prev 14(7):1588–1595

    Article  PubMed  Google Scholar 

  23. Speck RM, Courneya KS, Mâsse LC, Duval S, Schmitz KH (2010) An update of controlled physical activity trials in cancer survivors: a systematic review and meta-analysis. J Cancer Surviv 4(2):87–100

    Article  PubMed  Google Scholar 

  24. Singh B, Spence RR, Steele ML, Sandler CX, Peake JM, Hayes SC (2018) A systematic review and meta-analysis of the safety, feasibility, and effect of exercise in women with stage II+ breast cancer. Arch Phys Med Rehabil 99(12):2621–2636

    Article  PubMed  Google Scholar 

  25. De Lazzari N, Niels T, Tewes M, Götte M (2021) A systematic review of the safety, feasibility and benefits of exercise for patients with advanced cancer. Cancers 13(17):4478–4497

  26. Ainsworth BE, Haskell WL, Whitt MC, Irwin ML, Swartz AM, Strath SJ et al (2000) Compendium of physical activities: an update of activity codes and MET intensities. Med Sci Sports Exerc 32(9 Suppl):S498-504

    Article  CAS  PubMed  Google Scholar 

  27. Ainsworth BE, Haskell WL, Herrmann SD, Meckes N, Bassett DR Jr, Tudor-Locke C et al (2011) 2011 Compendium of Physical Activities: a second update of codes and MET values. Med Sci Sports Exerc 43(8):1575–1581

    Article  PubMed  Google Scholar 

  28. Beauchamp TL (2007) The ‘four principles’ approach to health care ethics. In: Ashcroft RE, Dawson A, Draper H, McMillan J (eds) Principles of Health Care Ethics, 2nd edn. Great Britain, John Wiley & Sons, Ltd, pp 3–10

    Google Scholar 

  29. American College of Sports Medicine (2022) ACSM’s guidelines for exercise testing and prescription. Lippincott Williams & Wilkins, Philadelphia

    Google Scholar 

  30. Denlinger CS, Sanft T, Baker KS, Broderick G, Demark-Wahnefried W, Friedman DL et al (2018) Survivorship, Version 2.2018, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw 16(10):1216–1247

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  31. American College of Sports Medicine (2018) ACSM’s guidelines for exercise testing and prescription. In: Riebe D, Ehrman JK, Liguori G, Magal M (ed). Wolters Kluwer Health, Philadelphia

  32. Winters-Stone KM, Neil SE, Campbell KL (2014) Attention to principles of exercise training: a review of exercise studies for survivors of cancers other than breast. Br J Sports Med 48(12):987–995

    Article  PubMed  Google Scholar 

  33. Bland KA, Neil-Sztramko SE, Zadravec K, Medysky ME, Kong J, Winters-Stone KM et al (2021) Attention to principles of exercise training: an updated systematic review of randomized controlled trials in cancers other than breast and prostate. BMC Cancer 21(1):1179

    Article  PubMed  PubMed Central  Google Scholar 

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Funding

MC is supported by the Four Diamonds Research Funds, Department of Pediatrics, Division of Hematology and Oncology, Penn State University College of Medicine. MP is funded by a postdoctoral fellowship from the National Institutes of Health, National Cancer Institute, (F32CA247263). BG is funded by a postdoctoral fellowship from the National Institute on Aging (F32AG078229).

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Authors and Affiliations

  1. Division of Hematology and Oncology, Department of Pediatrics, Penn State College of Medicine, Hershey, PA, USA

    Maxime Caru

  2. Department of Public Health Sciences, Penn State College of Medicine, Hershey, PA, USA

    Maxime Caru, Kathleen M. Sturgeon & Brett Gordon

  3. Department of Radiation Oncology, University Hospitals Seidman Cancer Center, Case Western Reserve School of Medicine, Cleveland, OH, USA

    Nicholas G. Zaorsky

  4. Division of Hematology and Oncology, University of Pittsburgh, Pittsburgh, PA, USA

    Melanie Potiaumpai, Shawna Doerksen & Kathryn H. Schmitz

Authors
  1. Maxime Caru
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  2. Nicholas G. Zaorsky
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  3. Kathleen M. Sturgeon
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  4. Melanie Potiaumpai
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  5. Brett Gordon
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  6. Shawna Doerksen
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  7. Kathryn H. Schmitz
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Contributions

MC and KHS conceived the study and participated in is design. MC, NGZ, KMS, MP, BG, SD and KHS made substantial contributions to the interpretation of the data. MC, NGZ, KMS, MP, BG, SD and KHS critically drafted or revised the manuscript for important intellectual content. MC, NGZ, KMS, MP, BG, SD and KHS provided final approval of the version to be published and agreed to be accountable for all aspects of the review in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

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Correspondence to Maxime Caru.

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Caru, M., Zaorsky, N.G., Sturgeon, K.M. et al. Exercise oncology clinical trials during treatments: a commentary to address the safety concerns of human subjects regulatory reviewers and committees. Support Care Cancer 32, 269 (2024). https://doi.org/10.1007/s00520-024-08471-w

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