Feasibility and Safety of Physical Exercise in Men With Prostate Cancer

NCT04500080 | Completed

• 1 other identifier: 520/2020/SPER/IRCCSRE
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer; Androgen Deprivation Therapy; Radiotherapy

Keywords

Exercise; Feasibility; Safety

Outcome Measures

Primary Outcomes (5)

• Feasibility - Recruitment rate

  Percentage ratio between patients included in the study and number of participants screened for recruitment.

  At baseline (T0)

• Feasibility - Adherence rate to the exercise program

  Determine the percentage of patients adhering to the program and the weekly exercise sessions.

  Throughout the 20 week study period

• Feasibility - Dropout rate

  Percentage of patients that withdraw from the study and the reason to withdraw

  Throughout the 20 week study period

• Feasibility - Safety/Adverse events

  Any adverse events, related or not related to the exercise program, will be documented

  Throughout the 20 week study period

• Feasibility - Compliance and patients' experience

  Determined by qualitative evaluation, using interviews, to assess experiences, accessibility and acceptability of the exercise intervention.

  Following the study conclusion at 20 weeks.

Secondary Outcomes (7)

• Change of muscular strength assessment

  At baseline and 20 weeks.

• Change of cognitive status assessment

  At baseline and 20 weeks.

• Change of fatigue assessment

  At baseline and 20 weeks.

• Change of fall risk assessment

  At baseline and 20 weeks.

• Change of anxiety and depression level

  At baseline and 20 weeks.

Study Arms (1)

PE intervention

EXPERIMENTAL

Aerobic, resistance, and neuromotor exercise

Behavioral: PE Intervention

Interventions

PE Intervention BEHAVIORAL

Each single exercise session will last for one hour and will consist of a combination of the following elements: * Aerobic Exercise (AE): 20-30 minutes at moderate-high intensity, from 60 to 80% of the maximum heart rate (% HRmax). * Resistance Exercise (RE): 30 minutes of strength activity of the major muscle groups. * Neuromotor Exercise (NE): will be integrated with strength exercises and will consist of jumping, balance and coordination activities

PE intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

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

Sponsors & Collaborators

• Azienda USL Reggio Emilia - IRCCS: lead
• Fondazione Manodori di Reggio Emilia: collaborator
• University of Modena and Reggio Emilia: collaborator

Study Sites (1)

Azienda USL-IRCCS di Reggio Emilia

Reggio Emilia, Emilia-Romagna, 42123, Italy

Location

Related Publications (6)

• 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.

  PMID: 28263373 RESULT

• 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.

  PMID: 20559064 RESULT

• 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.

  PMID: 29514170 RESULT

• 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.

  PMID: 24344218 RESULT

• 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.

  PMID: 26632144 RESULT

• 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.

  PMID: 35292485 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Behavior

Study Officials

• Stefania Costi, Ph.D.

  Azienda Unità Sanitaria Locale-IRCCS di Reggio Emilia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Feasibility pilot study

Study Record Dates

• First Submitted: August 1, 2020
• First Posted: August 5, 2020
• Study Start: April 14, 2020
• Primary Completion: January 31, 2022
• Study Completion: September 30, 2022
• Last Updated: October 19, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)