Clinical trial NCT04500080: Feasibility and Safety of Physical Exercise in Men With Prostate Cancer
Official title: Feasibility and Safety of Physical Exercise Program in Men With Prostate Cancer Receiving Androgen Deprivation Therapy and Radiotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Androgen Deprivation Therapy
Radiotherapy
Keywords: Exercise
Feasibility
Safety
Lead sponsor: Azienda USL Reggio Emilia - IRCCS
Sponsor class: OTHER_GOV
Collaborators: name: Fondazione Manodori di Reggio Emilia
name: University of Modena and Reggio Emilia
First posted: 2020-08-05
Enrollment: 5
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Feasibility pilot study
Primary purpose: SUPPORTIVE_CARE

Brief summary: Prostate cancer (PCa) is among the most widespread in the male population and represents 19% of all cancers diagnosed from the age of fifty, in Italy. Androgen deprivation therapy (ADT) and Radiotherapy (RT) are used for increase survival. However, both therapies are associated with significant side effects, such as fatigue, loss of muscle mass and strength, cognitive decline that together lead to an increase risk of accidental falls and fractures.

Guidelines for cancer survivors recommend Physical Exercise (PE) as a strategy to reduce several side effects of therapies. However, most people living with cancer do not meet current exercise recommendations.

Indeed, an effective PE program requires the application of long-term, moderate to high intensity activity. Thus it may be difficult to implement this type of recommendation in patient with PCa.

Therefore, this study aims to develop an experimental PE intervention testing their feasibility and safety and the patients' satisfaction, aimed at improving the health conditions of the patients with PCa receiving ADT and RT. Furthermore, long-term falls and fracture events will be monitored.

Detailed description: The non-randomized feasibility and pilot study aims to evaluate the feasibility and safety of a structured, multicomponent, supervised and unsupervised exercise program.

Secondary outcome will be evaluate the change in the health condition, in particular muscle strength, cognitive function, fatigue, balance, anxiety and depression level, and quality of life.

The PE program will be conducted at the "Virgilio Camparada" Municipal Athletic Track in the city of Reggio Emilia (IT). Patients will be participate in a supervised exercise program with three sessions per week, for eight weeks. Subsequently, the intervention will continue further for four weeks maintaining one supervised session and two unsupervised sessions a week. Finally, sessions will be performed without supervision for further eight weeks. The overall duration of the intervention will be twenty weeks. In addition, an evaluation will be performed at one year from baseline to monitor long-term fall and fracture events.

At baseline will be the following assessment:

- clinical and anthropometric data and the Six Minute Walking Test (6MWT) to determine the intensity of aerobic exercise.

Eligibility criteria: Inclusion Criteria:

* Histologically documented diagnosis of PCa;
* Undergo ADT and RT during the study period;
* At least 18 years old;
* Willing and able to give written informed consent;
* Able to read and understand Italian Language;

Exclusion Criteria:

* Musculoskeletal, cardiovascular, neurological or psychiatric disorders that contraindicate participation in an exercise program.

Primary outcomes:
measure: Feasibility - Recruitment rate
timeFrame: At baseline (T0)
measure: Feasibility - Adherence rate to the exercise program
timeFrame: Throughout the 20 week study period
measure: Feasibility - Dropout rate
timeFrame: Throughout the 20 week study period
measure: Feasibility - Safety/Adverse events
timeFrame: Throughout the 20 week study period
measure: Feasibility - Compliance and patients' experience
timeFrame: Following the study conclusion at 20 weeks.
Secondary outcomes:
measure: Change of muscular strength assessment
timeFrame: At baseline and 20 weeks.
measure: Change of cognitive status assessment
timeFrame: At baseline and 20 weeks.
measure: Change of fatigue assessment
timeFrame: At baseline and 20 weeks.
measure: Change of fall risk assessment
timeFrame: At baseline and 20 weeks.
measure: Change of anxiety and depression level
timeFrame: At baseline and 20 weeks.
measure: Change of quality of life assessment
timeFrame: At baseline and 20 weeks.
measure: Falls and fractures.
timeFrame: Throughout the 20 week study period and at one year of follow-up.
Other outcomes:
Locations:
city: Reggio Emilia
country: Italy
facility: Azienda USL-IRCCS di Reggio Emilia
state: Emilia-Romagna
Study officials:
affiliation: Azienda Unità Sanitaria Locale-IRCCS di Reggio Emilia
name: Stefania Costi, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Winters-Stone KM, Moe E, Graff JN, Dieckmann NF, Stoyles S, Borsch C, Alumkal JJ, Amling CL, Beer TM. Falls and Frailty in Prostate Cancer Survivors: Current, Past, and Never Users of Androgen Deprivation Therapy. J Am Geriatr Soc. 2017 Jul;65(7):1414-1419. doi: 10.1111/jgs.14795. Epub 2017 Mar 6.
citation: 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; American College of Sports Medicine. American College of Sports Medicine roundtable on exercise guidelines for cancer survivors. Med Sci Sports Exerc. 2010 Jul;42(7):1409-26. doi: 10.1249/MSS.0b013e3181e0c112.
citation: Feng LR, Espina A, Saligan LN. Association of Fatigue Intensification with Cognitive Impairment during Radiation Therapy for Prostate Cancer. Oncology. 2018;94(6):363-372. doi: 10.1159/000487081. Epub 2018 Mar 7.
citation: Gardner JR, Livingston PM, Fraser SF. Effects of exercise on treatment-related adverse effects for patients with prostate cancer receiving androgen-deprivation therapy: a systematic review. J Clin Oncol. 2014 Feb 1;32(4):335-46. doi: 10.1200/JCO.2013.49.5523. Epub 2013 Dec 16.
citation: Bourke L, Smith D, Steed L, Hooper R, Carter A, Catto J, Albertsen PC, Tombal B, Payne HA, Rosario DJ. Exercise for Men with Prostate Cancer: A Systematic Review and Meta-analysis. Eur Urol. 2016 Apr;69(4):693-703. doi: 10.1016/j.eururo.2015.10.047. Epub 2015 Nov 26.
citation: Bressi B, Iotti C, Cagliari M, Cavuto S, Fugazzaro S, Costi S. Feasibility and safety of physical exercise in men with prostate cancer receiving androgen deprivation therapy and radiotherapy: a study protocol. BMJ Open. 2022 Mar 15;12(3):e048854. doi: 10.1136/bmjopen-2021-048854.