Prostate CancerPCa_ExNCT04500080
Feasibility and Safety of Physical Exercise in Men With Prostate Cancer
A study testing PE Intervention in people with Prostate Cancer and Androgen Deprivation Therapy, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Androgen Deprivation Therapy, Radiotherapy
- What is being tested?
- PE Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteItaly
- Study dates
- 14 Apr 2020to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- Musculoskeletal, cardiovascular, neurological or psychiatric disorders that contraindicate participation in an exercise program.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Azienda USL-IRCCS di Reggio Emilia
Reggio Emilia, Emilia-Romagna, 42123
About this study
Official title: Feasibility and Safety of Physical Exercise Program in Men With Prostate Cancer Receiving Androgen Deprivation Therapy and Radiotherapy
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.
Read more
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.
Read the 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.
- Conditions
- Prostate Cancer, Androgen Deprivation Therapy, Radiotherapy
- Being tested
- PE Intervention
- Keywords
- Exercise, Feasibility, Safety
- Medical subject headings
- Prostatic Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PE InterventionBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| PE intervention | Experimental | Aerobic, resistance, and neuromotor exercise Receives: Behavioral: PE Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility - Recruitment rate
Percentage ratio between patients included in the study and number of participants screened for recruitment.
Measured: At baseline (T0)
Feasibility - Adherence rate to the exercise program
Determine the percentage of patients adhering to the program and the weekly exercise sessions.
Measured: Throughout the 20 week study period
Feasibility - Dropout rate
Percentage of patients that withdraw from the study and the reason to withdraw
Measured: Throughout the 20 week study period
Feasibility - Safety/Adverse events
Any adverse events, related or not related to the exercise program, will be documented
Measured: 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.
Measured: Following the study conclusion at 20 weeks.
Secondary outcomes (7)
Change of muscular strength assessment
Lower body muscle strength will be determined with the 10-repetitions maximum test.
Measured: At baseline and 20 weeks.
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.
Measured: At baseline and 20 weeks.
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.
Measured: At baseline and 20 weeks.
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.
Measured: At baseline and 20 weeks.
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.
Measured: At baseline and 20 weeks.
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.
Measured: At baseline and 20 weeks.
Falls and fractures.
Registration of number of falls and fractures events through patient interview.
Measured: Throughout the 20 week study period and at one year of follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start14 Apr 2020
- Primary completion31 Jan 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Feasibility pilot study
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCS
- Sponsor type
- Other government
- Collaborators
- Fondazione Manodori di Reggio Emilia, University of Modena and Reggio Emilia
- Responsible party
- Sponsor
- Investigators
- Stefania Costi, Ph.D., Principal investigator, Azienda Unità Sanitaria Locale-IRCCS di Reggio Emilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04500080
- Sponsor's protocol ID
- 520/2020/SPER/IRCCSRE
- Acronym
- PCa_Ex
- Status last verified
- Oct 2022
- First submitted
- 1 Aug 2020
- Last updated
- 19 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28263373Schmitz 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.
PubMed 20559064Feng 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.
PubMed 29514170Gardner 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.
PubMed 24344218Bourke 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.
PubMed 26632144Bressi 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.
PubMed 35292485
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Safety of Physical Exercise Program in Men With Prostate Cancer Receiving Androgen Deprivation Therapy and Radiotherapy
- ClinicalTrials.gov ID
- NCT04500080
- Acronym / sponsor ID
- PCa_Ex / 520/2020/SPER/IRCCSRE
- Conditions
- Prostate Cancer, Androgen Deprivation Therapy, Radiotherapy
- Keywords
- Exercise, Feasibility, Safety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCSOther government
- Collaborators
- Fondazione Manodori di Reggio Emilia, University of Modena and Reggio Emilia
- Study start
- 14 Apr 2020 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 5 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Feasibility pilot study
| Arm | Type | Receives |
|---|---|---|
| PE intervention | Experimental | Behavioral: PE InterventionAerobic, resistance, and neuromotor exercise |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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;
Key exclusion criteria (1 listed)
- Musculoskeletal, cardiovascular, neurological or psychiatric disorders that contraindicate participation in an exercise program.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PE InterventionEach 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 | Behavioural | PE intervention |
Primary outcome
Feasibility - Recruitment rate
Time frame: At baseline (T0)
Percentage ratio between patients included in the study and number of participants screened for recruitment.
Feasibility - Adherence rate to the exercise program
Time frame: Throughout the 20 week study period
Determine the percentage of patients adhering to the program and the weekly exercise sessions.
Feasibility - Dropout rate
Time frame: Throughout the 20 week study period
Percentage of patients that withdraw from the study and the reason to withdraw
Feasibility - Safety/Adverse events
Time frame: Throughout the 20 week study period
Any adverse events, related or not related to the exercise program, will be documented
Feasibility - Compliance and patients' experience
Time frame: Following the study conclusion at 20 weeks.
Determined by qualitative evaluation, using interviews, to assess experiences, accessibility and acceptability of the exercise intervention.
7 secondary outcomes
Change of muscular strength assessment
Time frame: At baseline and 20 weeks.
Change of cognitive status assessment
Time frame: At baseline and 20 weeks.
Change of fatigue assessment
Time frame: At baseline and 20 weeks.
Change of fall risk assessment
Time frame: At baseline and 20 weeks.
Change of anxiety and depression level
Time frame: At baseline and 20 weeks.
Change of quality of life assessment
Time frame: At baseline and 20 weeks.
Falls and fractures.
Time frame: Throughout the 20 week study period and at one year of follow-up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2022.
- Results publication: PubMed 28263373Winters-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.
- Results publication: PubMed 20559064Schmitz 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.
- Results publication: PubMed 29514170Feng 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.
- Results publication: PubMed 24344218Gardner 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.
- Results publication: PubMed 26632144Bourke 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.
- Derived from this study: PubMed 35292485Bressi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefania Costi, Ph.D. principal investigator
Azienda Unità Sanitaria Locale-IRCCS di Reggio Emilia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PE Intervention in people with Prostate Cancer and Androgen Deprivation Therapy, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility - Recruitment rate (time frame: At baseline (T0)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04500080, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2022.