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Exercise prescription dose for castrate-resistant prostate cancer patients: a phase I prescription dose escalation trial

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Abstract

Purpose

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.

Methods

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.

Results

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.

Conclusion

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.

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Abbreviations

ADT:

Androgen Deprivation Therapy

ACSM:

American College of Sport Medicine

BIA:

Bioelectrical Impedance Analysis

BPI:

Brief Pain Inventory

CPET:

Cardiopulmonary Exercise Test

mCRPC:

Metastatic Castrate-resistant Prostate Cancer

CTCAE:

Common Terminology Criteria for Adverse Events

HRQoL:

Health-related Quality of Life

IPAQ:

International Physical Activity Questionnaire

KPS:

Karnofsky Performance Score

MTP:

Maximum Tolerated Prescription

PCa:

Prostate Cancer

VAS:

Visual Analog Scale

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Acknowledgements

RB is supported by a PhD fellowship of The Research Foundation—Flanders (FWO).

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Authors and Affiliations

Authors

Contributions

RB: conception and design, protocol development, data collection and analysis, manuscript writing. BD: conception and design, protocol development, data analysis, manuscript editing. NB: protocol development, data collection, manuscript editing. JVB: protocol development, manuscript editing. ML: conception and design, protocol development, data collection and analysis, manuscript editing. ER: protocol development, manuscript editing. VF: protocol development, manuscript editing. KD: protocol development, manuscript editing. AS: conception and design, protocol development, data collection and analysis, manuscript editing. NL: protocol development, manuscript editing. PO: conception and design, protocol development, data analysis, manuscript editing, project supervision.

Corresponding author

Correspondence to Renée Bultijnck.

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The authors declare that they have no conflict of interest with respect to the research, authorship and/or publication of this article.

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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee (Ethics Committee of the University Hospital of Ghent, number 2017/1099) and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

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Informed consent was obtained from all individual participants included in the study.

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Bultijnck, R., Deforche, B., Borrey, N. et al. Exercise prescription dose for castrate-resistant prostate cancer patients: a phase I prescription dose escalation trial. World J Urol 39, 357–364 (2021). https://doi.org/10.1007/s00345-020-03098-y

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  • DOI: https://doi.org/10.1007/s00345-020-03098-y

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