Feasibility and Safety of Physical Exercise in Men With Prostate Cancer

Prostate Cancer Clinical Trial

— PCa_Ex  

Official title:

Feasibility and Safety of Physical Exercise Program in Men With Prostate Cancer Receiving Androgen Deprivation Therapy and Radiotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04500080
• Other study ID #: 520/2020/SPER/IRCCSRE
• Status: Completed
• Phase: N/A
• Start date: April 14, 2020
• Est. completion date: September 30, 2022

Study information

• Verified date: October 2022
• Source: Azienda Unità Sanitaria Locale Reggio Emilia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: September 30, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Androgen Deprivation Therapy
• Prostate Cancer
• Prostatic Neoplasms
• Radiotherapy

Intervention

Behavioral:
• PE Intervention
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

Locations

Country	Name	City	State
Italy	Azienda USL-IRCCS di Reggio Emilia	Reggio Emilia	Emilia-Romagna

Sponsors (3)

Lead Sponsor	Collaborator
Azienda Unità Sanitaria Locale Reggio Emilia	Fondazione Manodori di Reggio Emilia, University of Modena and Reggio Emilia

Country where clinical trial is conducted

Italy, 

References & Publications (5)

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 — View 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. — View 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.2013.49.5 — View Citation

Schmitz KH, Courneya KS, Matthews C, Demark-Wahnefried W, Galvão 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 exerc — View 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):1414-141 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility - Recruitment rate	Percentage ratio between patients included in the study and number of participants screened for recruitment.	At baseline (T0)
Primary	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
Primary	Feasibility - Dropout rate	Percentage of patients that withdraw from the study and the reason to withdraw	Throughout the 20 week study period
Primary	Feasibility - Safety/Adverse events	Any adverse events, related or not related to the exercise program, will be documented	Throughout the 20 week study period
Primary	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	Change of muscular strength assessment	Lower body muscle strength will be determined with the 10-repetitions maximum test.	At baseline and 20 weeks.
Secondary	Change of cognitive status assessment	Cognitive status will be assess using the Mini Mental State Examination (MMSE), a 30-point questionnaire italian version. A score of 24 or more (out of 30) indicates a normal cognition.	At baseline and 20 weeks.
Secondary	Change of fatigue assessment	Fatigue will be measured using the Fatigue Severity Scale (FSS). FSS is a 9-item questionnaire on how fatigue interferes activities and rates its severity. The item are scored on a 7 point scale with 1 = strongly disagree and 7 = strongly agree. The minimum score = 9, maximum score = 63. Higher score means greater fatigue severity.	At baseline and 20 weeks.
Secondary	Change of fall risk assessment	Fall risk will be assessed using the Tinetti Performance Oriented Mobility Assessment (POMA). The Tinetti POMA is a clinical test used to measure balance and gait abilities. The balance section (POMA-B) consists of 9 items while the gait section (POMA-G) consists of 8 items.Each of these items has answer choices that are weighted on an ordinal scale from 0 to 1 or 2. "0" indicates the highest level of impairment and "2" the individuals independence. The maximum possible total score for POMA-T is 28, for POMA-B is 16, and for POMA-G is 12.	At baseline and 20 weeks.
Secondary	Change of anxiety and depression level	Depression and anxiety level will be measured using the Hospital Anxiety and Depression Scale (HADS). The HADS is a fourteen item scale, seven relate to anxiety and seven relate to depression. The total score goes from 0-21. Higher total scores indicate greater levels of depression.	At baseline and 20 weeks.
Secondary	Change of quality of life assessment	Quality of life will be measured by a Short form-12 questionnaire (SF-12). The SF-12 is a health-related quality-of-life questionnaire consisting of twelve questions that measure eight health domains to assess physical and mental health. Higher scores indicate a better physical and mental health.	At baseline and 20 weeks.
Secondary	Falls and fractures.	Registration of number of falls and fractures events through patient interview.	Throughout the 20 week study period and at one year of follow-up.