Exercise prescription dose for castrate-resistant prostate cancer patients: a phase I prescription dose escalation trial.
Castration-resistant prostate cancer
Exercise
Phase 1
Physical activity
Journal
World journal of urology
ISSN: 1433-8726
Titre abrégé: World J Urol
Pays: Germany
ID NLM: 8307716
Informations de publication
Date de publication:
Feb 2021
Feb 2021
Historique:
received:
13
06
2019
accepted:
19
01
2020
pubmed:
3
2
2020
medline:
23
7
2021
entrez:
3
2
2020
Statut:
ppublish
Résumé
To determine the start exercise prescription dose in metastatic castrate-resistant prostate cancer (mCRPC) patients receiving second-line hormone treatment and recommended phase II exercise prescription. Patients were enrolled in a 3 + 3 dose escalation phase I trial of aerobic, resistance, and flexibility exercises to evaluate dose-limiting tolerance and safety. Tolerance was defined as Borg score ≤ 16 and safety (pain) as a visual analogue scale score (VAS) ≤ 3 and CTCAE grade < 2. Dose level 1 (escalation start dose) was set at 15 min. Aerobic training (50-80% HRmax warm-up and cooling-down; and 65-80% HRmax. core), 1 set with 8-10 repetitions (reps.) resistance training (50-60% 1-RM, 8 exercises), and 1 set (30s) with 2 reps flexibility training (5 exercises). The prescription dose escalation was designed in four levels (from dose -1 to 3), with a dose escalation in volume and intensity of the exercises. Nine patients were included in two dosing cohorts and were under active treatment (n = 4 abiraterone acetate and n = 5 enzalutamide). Dose limiting safety concerns were observed in 2 out of 3 patients in dose level 2 and 1 patient out of 6 in dose level 1 due to VAS > 3 during resistance training and/or flexibility training. No tolerance issues were observed in the two dosing cohorts. The optimal start exercise prescription dose was set at dose level 1 due to safety issues at dose level 2. Our findings suggest that exercise is perceived tolerable in mCRPC patients receiving second-line hormone therapy. Caution is indicated on safety during performance of the exercises.
Identifiants
pubmed: 32008114
doi: 10.1007/s00345-020-03098-y
pii: 10.1007/s00345-020-03098-y
doi:
Types de publication
Clinical Trial, Phase I
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
357-364Subventions
Organisme : The Research Foundation - Flanders (FWO)
ID : 1158018N
Références
Cornford P, Bellmunt J, Bolla M, Briers E, De Santis M, Gross T, Henry AM, Joniau S, Lam TB, Mason MD (2016) EAU-ESTRO-SIOG Guidelines on Prostate Cancer. Part II: treatment of relapsing, metastatic, and castration-resistant prostate cancer. Eur Urol 71(4):630–642. https://doi.org/10.1016/j.eururo.2016.08.002
Parker C, Gillessen S, Heidenreich A, Horwich A (2015) Cancer of the prostate: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol 26(suppl 5):v69–v77. https://doi.org/10.1093/annonc/mdv222
doi: 10.1093/annonc/mdv222
pubmed: 26205393
Moreira RB, Debiasi M, Francini E, Nuzzo PV, De Velasco G, Maluf FC, Fay AP, Bellmunt J, Choueiri TK, Schutz FA (2017) Differential side effects profile in patients with mCRPC treated with abiraterone or enzalutamide: a meta-analysis of randomized controlled trials. Oncotarget 8(48):84572
doi: 10.18632/oncotarget.20028
Nguyen PL, Alibhai SM, Basaria S, D’Amico AV, Kantoff PW, Keating NL, Penson DF, Rosario DJ, Tombal B, Smith MR (2014) Adverse effects of androgen deprivation therapy and strategies to mitigate them. Eur Urol 67(5):825–836
doi: 10.1016/j.eururo.2014.07.010
Friedenreich CM, Wang Q, Neilson HK, Kopciuk KA, McGregor SE, Courneya KS (2016) Physical activity and survival after prostate cancer. Eur Urol 70(4):576–585. https://doi.org/10.1016/j.eururo.2015.12.032
doi: 10.1016/j.eururo.2015.12.032
pubmed: 26774959
Schmitz KH, Courneya KS, Matthews C, Demark-Wahnefried W, Galvao DA, Pinto BM, Irwin ML, Wolin KY, Segal RJ, Lucia A, Schneider CM, von Gruenigen VE, Schwartz AL (2010) American College of Sports Medicine roundtable on exercise guidelines for cancer survivors. Med Sci Sports Exerc 42(7):1409–1426. https://doi.org/10.1249/MSS.0b013e3181e0c112
doi: 10.1249/MSS.0b013e3181e0c112
pubmed: 20559064
Schmitz KH, Campbell AM, Stuiver MM, Pinto BM, Schwartz AL, Morris GS, Ligibel JA, Cheville A, Galvao DA, Alfano CM, Patel AV, Hue T, Gerber LH, Sallis R, Gusani NJ, Stout NL, Chan L, Flowers F, Doyle C, Helmrich S, Bain W, Sokolof J, Winters-Stone KM, Campbell KL, Matthews CE (2019) Exercise is medicine in oncology: engaging clinicians to help patients move through cancer. CA Cancer J Clin 69(6):468–484. https://doi.org/10.3322/caac.21579
Le Tourneau C, Lee JJ, Siu LL (2009) Dose escalation methods in phase I cancer clinical trials. JNCI 101(10):708–720
Borg GA (1982) Psychophysical bases of perceived exertion. Med Sci Sports Exerc 14(5):377–381
doi: 10.1249/00005768-198205000-00012
Galvao DA, Spry N, Denham J, Taaffe DR, Cormie P, Joseph D, Lamb DS, Chambers SK, Newton RU (2014) A multicentre year-long randomised controlled trial of exercise training targeting physical functioning in men with prostate cancer previously treated with androgen suppression and radiation from TROG 03.04 RADAR. Eur Urol 65(5):856–864. https://doi.org/10.1016/j.eururo.2013.09.041
Bourke L, Gilbert S, Hooper R, Steed LA, Joshi M, Catto JW, Saxton JM, Rosario DJ (2014) Lifestyle changes for improving disease-specific quality of life in sedentary men on long-term androgen-deprivation therapy for advanced prostate cancer: a randomised controlled trial. Eur Urol 65(5):865–872. https://doi.org/10.1016/j.eururo.2013.09.040
doi: 10.1016/j.eururo.2013.09.040
pubmed: 24119318
Cormie P, Newton RU, Spry N, Joseph D, Taaffe DR, Galvao DA (2013) Safety and efficacy of resistance exercise in prostate cancer patients with bone metastases. Prostate Cancer Prostatic Dis 16(4):328–335. https://doi.org/10.1038/pcan.2013.22
doi: 10.1038/pcan.2013.22
pubmed: 23917308
Galvao DA, Taaffe DR, Spry N, Cormie P, Joseph D, Chambers SK, Chee R, Peddle-McIntyre CJ, Hart NH, Baumann FT, Denham J, Baker M, Newton RU (2018) Exercise preserves physical function in prostate cancer patients with bone metastases. Med Sci Sports Exerc 50(3):393–399. https://doi.org/10.1249/mss.0000000000001454
doi: 10.1249/mss.0000000000001454
pubmed: 29036016
Beaver WL, Wasserman K, Whipp BJ (1986) A new method for detecting anaerobic threshold by gas exchange. J Appl Physiol 60(6):2020–2027. https://doi.org/10.1152/jappl.1986.60.6.2020
Peus D, Newcomb N, Hofer S (2013) Appraisal of the Karnofsky performance status and proposal of a simple algorithmic system for its evaluation. BMC Med Inform Decis Mak 13:72. https://doi.org/10.1186/1472-6947-13-72
doi: 10.1186/1472-6947-13-72
pubmed: 23870327
pmcid: 3722041
Lange-Maia BS, Newman AB, Strotmeyer ES, Harris TB, Caserotti P, Glynn NW (2015) Performance on fast- and usual-paced 400-m walk tests in older adults: are they comparable? Aging Clin Exp Res 27(3):309–314. https://doi.org/10.1007/s40520-014-0287-y
doi: 10.1007/s40520-014-0287-y
pubmed: 25373610
Hagstromer M, Oja P, Sjostrom M (2006) The International Physical Activity Questionnaire (IPAQ): a study of concurrent and construct validity. Public Health Nutr 9(6):755–762
doi: 10.1079/PHN2005898
Cleeland CS (6242s) The measurement of pain from metastatic bone disease: capturing the patient's experience. Clin Cancer Res 12(20):6236s–6242s. https://doi.org/10.1158/1078-0432.CCR-06-0988
doi: 10.1158/1078-0432.CCR-06-0988
pubmed: 17062707
Bosy-Westphal A, Schautz B, Later W, Kehayias J, Gallagher D, Müller M (2013) What makes a BIA equation unique? Validity of eight-electrode multifrequency BIA to estimate body composition in a healthy adult population. Eur J Clin Nutr 67:S14–S21
doi: 10.1038/ejcn.2012.160
Sheill G, Guinan EM, Peat N, Hussey J (2018) Considerations for exercise prescription in patients with bone metastases: a comprehensive narrative review. PM R. https://doi.org/10.1016/j.pmrj.2018.02.006
doi: 10.1016/j.pmrj.2018.02.006
pubmed: 29474996
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. https://doi.org/10.1007/s00520-017-3827-0
doi: 10.1007/s00520-017-3827-0
pubmed: 28741176
Newton RU, Kenfield SA, Hart NH, Chan JM, Courneya KS, Catto J, Finn SP, Greenwood R, Hughes DC, Mucci L, Plymate SR, Praet SFE, Guinan EM, Van Blarigan EL, Casey O, Buzza M, Gledhill S, Zhang L, Galvao DA, Ryan CJ, Saad F (2018) Intense exercise for survival among men with metastatic castrate-resistant prostate cancer (INTERVAL-GAP4): a multicentre, randomised, controlled phase III study protocol. BMJ Open 8(5):e022899. https://doi.org/10.1136/bmjopen-2018-022899
doi: 10.1136/bmjopen-2018-022899
pubmed: 29764892
pmcid: 5961562
Østergren P, Ragle A-M, Jakobsen H, Klausen TW, Vinther A, Sønksen J (2016) Group-based exercise in daily clinical practice to improve physical fitness in men with prostate cancer undergoing androgen deprivation therapy: study protocol. BMJ Open 6(6):e011460. https://doi.org/10.1136/bmjopen-2016-011460
doi: 10.1136/bmjopen-2016-011460
pubmed: 27357198
pmcid: 4932293
Sheill G, Guinan E, Neill LO, Hevey D, Hussey J (2018) The views of patients with metastatic prostate cancer towards physical activity: a qualitative exploration. Support Care Cancer 26(6):1747–1754. https://doi.org/10.1007/s00520-017-4008-x
doi: 10.1007/s00520-017-4008-x
pubmed: 29243168
Foster C, Hector LL, Welsh R, Schrager M, Green MA, Snyder AC (1995) Effects of specific versus cross-training on running performance. Eur J Appl Physiol Occup Physiol 70(4):367–372
doi: 10.1007/BF00865035
Dite W, Langford ZN, Cumming TB, Churilov L, Blennerhassett JM, Bernhardt J (2015) A Phase 1 exercise dose escalation study for stroke survivors with impaired walking. Int J Stroke 10(7):1051–1056. https://doi.org/10.1111/ijs.12548
doi: 10.1111/ijs.12548
pubmed: 26121167
Peiris C, Shields N, Kingsley M, Yeung J, Hau R, Taylor N (2017) Maximum tolerated dose of walking for community-dwelling people recovering from hip fracture: a dose-response trial. Arch Phys Med Rehabil 98(12):2533–2539. https://doi.org/10.1016/j.apmr.2017.03.027
doi: 10.1016/j.apmr.2017.03.027
pubmed: 28465223
Brondfield SC, Weinberg VK, Koepfgen KM, Molina A, Ryan CJ, Small EJ, Harzstark AL (2012) Effects of 6 months of abiraterone acetate (AA) on muscle and adipose mass in men with metastatic castration-resistant prostate cancer (mCRPC). J Clin Oncol 30(5_suppl):222–222
Cormie P, Galvao DA, Spry N, Joseph D, Taaffe DR, Newton RU (2014) Functional benefits are sustained after a program of supervised resistance exercise in cancer patients with bone metastases: longitudinal results of a pilot study. Support Care Cancer 22(6):1537–1548. https://doi.org/10.1007/s00520-013-2103-1
doi: 10.1007/s00520-013-2103-1
pubmed: 24424484
Wall BA, Galvao DA, Fatehee N, Taaffe DR, Spry N, Joseph D, Newton RU (2014) Maximal exercise testing of men with prostate cancer being treated with androgen deprivation therapy. Med Sci Sports Exerc 46(12):2210–2215. https://doi.org/10.1249/mss.0000000000000353
doi: 10.1249/mss.0000000000000353
pubmed: 24694745