Castration-resistant Prostate CancerNCT03672396
Home-based Exercise Intervention for Patients With Metastatic Prostate Cancer
A study testing Home-based exercise in people with Castration-resistant Prostate Cancer and Androgen Deprivation Therapy, run by UNC Lineberger Comprehensive Cancer Center at 2 sites in United States.
Trial summary
This single arm, multi-site pilot study aims to evaluate the feasibility of recruiting and adherence to a 12 week home-based exercise intervention to be conducted in men with metastatic castration resistant prostate cancer (mCRPC) receiving androgen deprivation therapy (ADT). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Castration-resistant Prostate Cancer, Androgen Deprivation Therapy
- What is being tested?
- Home-based exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Apr 2017to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Metastatic disease that has progressed despite castrate levels of testosterone (surgically or medically castrated, with testosterone levels of < 50 ng/dL) receiving ADT. This will be verified by assessing total testosterone levels within 4 weeks prior to enrollment.
- No current chemotherapy.
- Patients may be receiving additional hormonal therapy agents including but not limited to antiandrogens (e.g. bicalutamide, enzalutamide) and CYP17 inhibitors (e.g. abiraterone).
- Ability to engage safely in moderate exercise as determined by their treating physician.
- Not previously engaged in regular exercise training (<3 or more d/wk for > 30 min/d or <90 mins per week total including strength training, aerobic training, or walking) in the past 6 months.
- Access to a computer or a smart phone for syncing and uploading wearable activity data.
- Be able to speak and read English.
Who cannot join
- Any condition that causes severe pain with exertion.
- History of bone fractures.
- Active cardiovascular disease including any of the following:
- New York Heart Association (NYHA) Grade II or greater congestive heart failure .
- History of myocardial infarction or unstable angina within 6 months prior to Day 1.
- History of stroke or transient ischemic attack within 6 months prior to Day 1.
Show all 10Show fewer
- Acute or chronic respiratory disease that is severe enough to compromise the ability of the participant to safely engage in exercise training protocol.
- Acute or chronic bone/joint/muscular abnormalities compromising their ability to exercise.
- Neurological conditions that affect balance and, or muscle strength.
- Dementia, altered mental status or any psychiatric condition prohibiting the understanding or rendering of informed consent.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, 27599
Comprehensive Cancer Center, Wake Forest Baptist Health
Winston-Salem, North Carolina, 27103
About this study
Official title: Feasibility Study of a Home-Based Exercise Intervention Program for Patients With Metastatic Castration-Resistant Prostate Cancer Receiving Androgen Deprivation Therapy (ADT)
This single arm, multi-site pilot study aims to evaluate the feasibility of recruiting and adherence to a 12 week home-based exercise intervention to be conducted in men with metastatic castration resistant prostate cancer (mCRPC) receiving androgen deprivation therapy (ADT). Thirty patients will be enrolled, with the expectation that 20-25 will complete all follow-up measures.
Read the detailed description
The purpose of this trial is to evaluate the feasibility and adherence to a home-based 12 week exercise intervention in mCRPC patients receiving ADT. It will also examine if a home-based exercise intervention can improve muscle strength, body composition, physical function, cardiopulmonary function fatigue, and patient reported outcomes (fatigue, depression, quality of life (QoL)).
- Being tested
- Home-based exercise
- Keywords
- exercise, hormone therapy
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based exerciseBehavioural
The intervention consists of aerobic and strength training ~3 times per week for 12 weeks with each session lasting 1 hour. The progressive aerobic exercise will involve walking that varies from from 15 to 30 minutes done 2-4 times per week at an intensity from 40% to 65% of heart rate reserve. Therabands elastic bands will be used to perform 12 to 15 repetitions per exercise. Once a participant can comfortably complete 15 repetitions for all prescribed sets, they will increase resistance by moving up to the next band. The training volume increased from 1 set per exercise on week 1 to 3 sets by week 12.
| Study group | Role | What they receive |
|---|---|---|
| Home-based Exercise | Experimental | The sole intervention group will complete a combination of aerobic and strength training ~3 times per week for 12 weeks with each session lasting 1 hour. Receives: Behavioral: Home-based exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients Who Complete the Pre/Post Exercise Intervention Testing.
To estimate the feasibility of a 12 week, home-based exercise intervention in metastatic castrate resistant prostate cancer (mCPRC) patients undergoing androgen deprivation therapy by reporting the percentage of patients who complete the pre/post testing following the intervention.
This was calculated as the number of subjects who completed the trial compared to the total number who completed baseline testing.
Measured: 12 weeks after baseline testing
Secondary outcomes (19)
Adherence to the Intervention
To report the level of adherence to the exercise intervention in patients completing pre/post testing. Successful adherence to the program is completion of 75% of all prescribed exercise and will be assessed using wearable technology to track walking and exercise logs to track resistance training adherence.
Adherence was determined as the number of exercise sessions attempted/completed over the total number of session prescribed.
Measured: 12 weeks after baseline testing
Physical Function: 6m Walk
The time to complete (in sec) the 6m rapid walk test will be performed.
Measured: 12 weeks after baseline testing
Physical Function: Timed Up and Go
The time to complete (in sec) the 2.44m (8 ft) timed up and go test will be performed as an indicator of agility, balance, and physical function. A lower total time is indicative of greater performance.
Measured: 12 weeks after baseline testing
Physical Function: Stair Climb
The time to climb a flight of stairs (in sec) will be performed as an indicator of functional strength, muscle power, and balance. A lower total time (and higher calculated power output) is indicative of greater performance.
Measured: 12 weeks after baseline testing
Physical Function: 400m Walk
The time to walk 400m (in sec) will be performed as an indicator of walking endurance and gait speed will be determined. A lower total time and higher gait speed indicates greater cardiorespiratory capacity and will be correlated with cardiopulmonary function scores (outcome 14).
Measured: 12 weeks after baseline testing
Patient Reported Outcomes: Fatigue
Fatigue will be measure using the Functional Assessment of Chronic Illness Therapy Fatigue, a 1 page form that uses a rating scale that goes from 0 to 52. It assesses the patient's fatigue levels in the last 7 days. It also measures how usual activities, performing work, walking, relationship, and enjoyment of life are affected by fatigue. A higher score indicates higher quality of life (and lower fatigue).
Measured: 12 weeks after baseline testing
Patient Reported Outcomes: Quality of Life
Quality of life will be measured using the Functional Assessment of Cancer Therapy-Prostate (FACT-P). The FACT-P is composed of both multi-item scales and single-item measures. These include physical, social, emotional, and functional well-being, along with an assessment of prostate-specific health status. five functional scales, three symptom scales, a global health status / QoL scale, and six single items. All of the individual questions are scored from 0-4 with total scores ranging between 0 and 156 where a higher number represents higher QoL.
Measured: 12 weeks after baseline testing
Patient Reported Outcomes: Depression
Depression will be measured using the Hospital Anxiety and Depression Scale, a concise, self-administered 1 page form that categorizes anxiety and depression. The total score goes from 0-21, and scores are categorized from minimal to severe depression/anxiety. Higher total scores indicate greater levels of depression.
Measured: 12 weeks after baseline testing
Patient Reported Outcomes: Anxiety
Depression will be measured using the Hospital Anxiety and Depression Scale, a concise, self-administered 1 page form that categorizes anxiety and depression. The total score goes from 0-21, and scores are categorized from minimal to severe depression/anxiety. Higher total scores indicate greater levels of depression.
Measured: 12 weeks after baseline testing
Muscle Size (Cross-sectional Area)
Muscle size will be analyzed using ultrasound of the vastus lateralis of the dominant leg. All assessments will be completed before and after the intervention to determine the muscle size. Higher muscle mass and quality are associated with greater muscle strength, physical function, QoL, and mortality.
Measured: 12 weeks after baseline testing
Muscle Quality
Muscle architecture will be analyzed using ultrasound of the vastus lateralis of the dominant leg. All assessments will be completed before and after the intervention to determine the muscle quality. Higher muscle mass and quality are associated with greater muscle strength, physical function, QoL, and mortality. Muscle quality is reported in arbitrary units, where a lower value indicates a higher/better muscle quality.
Measured: 12 weeks after baseline testing
Chest Press Maximal Strength
Upper and lower body muscle strength will be assessed using the chest and leg presses. Maximal strength is defined as the highest load (kilograms) that the participant can successfully lift one time. Greater maximal strength is associated with greater physical function and QoL.
Measured: 12 weeks after baseline testing
Chest Press Muscle Endurance
Upper and lower body muscle endurance will be assessed using the chest and leg presses. Muscle endurance is the total number of repetitions completed using 70% of maximal load determined during muscle strength testing (outcome 12). Greater muscle endurance are associated with greater physical function and QoL.
Measured: 12 weeks after baseline testing
Leg Press Maximal Strength
Upper and lower body muscle strength will be assessed using the chest and leg presses. Maximal strength is defined as the highest load (kilograms) that the participant can successfully lift one time. Greater maximal strength is associated with greater physical function and QoL.
Measured: 12 weeks after baseline testing
Leg Press Muscle Endurance
Upper and lower body muscle endurance will be assessed using the chest and leg presses. Muscle endurance is the total number of repetitions completed using 70% of maximal load determined during muscle strength testing (outcome 12). Greater muscle endurance are associated with greater physical function and QoL.
Measured: 12 weeks after baseline testing
Cardiopulmonary Function
To report changes in cardiopulmonary function following the intervention. Cardiopulmonary function (VO2 peak) will be assessed using a graded exercise test on a treadmill. Patients will begin the test walking slowly on the treadmill and every two minutes, the grade and speed of the treadmill will be increased in a progressive manner until fatigue occurs. Respiratory gases will be collected throughout the test and analyzed using a metabolic cart to determine oxygen utilization and carbon dioxide production. The maximal oxygen uptake that is recorded will be used as a marker of aerobic fitness.
Measured: 12 weeks after baseline testing
Lean Mass
To report changes in total lean mass following the intervention. Total body lean mass will be measured using dual-energy x-ray absorptiometry (DXA) before and after the intervention.
Measured: 12 weeks after baseline testing
Fat Mass
To report changes in total fat mass following the intervention. Total fat mass will be measured using dual-energy x-ray absorptiometry (DXA) before and after the intervention.
Measured: 12 weeks after baseline testing
Percent Body Fat
To report changes in relative fat mass following the intervention. Total body percent fat (percentage of fat mass relative to total mass) will be measured using dual-energy x-ray absorptiometry (DXA) before and after the intervention.
Measured: 12 weeks after baseline testing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2018
- Study start1 Apr 2017
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Castration-resistant Prostate CancerStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm study with \~30 men being recruited and 20-25 who complete all aspects of the study.
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Wake Forest University Health Sciences
- Responsible party
- Sponsor
- Investigators
- Erik D Hanson, PhD, Principal investigator, UNC-Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03672396
- Sponsor's protocol ID
- LCCC1613
- Status last verified
- Dec 2020
- First submitted
- 31 Aug 2018
- Last updated
- 20 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Both sites (UNC and WF) are adding and storing data on a secure, centralized server. No individual data will be made available to protect the identity of the patients in the trial.
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of a Home-Based Exercise Intervention Program for Patients With Metastatic Castration-Resistant Prostate Cancer Receiving Androgen Deprivation Therapy (ADT)
- ClinicalTrials.gov ID
- NCT03672396
- Acronym / sponsor ID
- LCCC1613
- Keywords
- exercise, hormone therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Wake Forest University Health Sciences
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 14 Sep 2018 (actual)
- Results
- Posted 12 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This single arm, multi-site pilot study aims to evaluate the feasibility of recruiting and adherence to a 12 week home-based exercise intervention to be conducted in men with metastatic castration resistant prostate cancer (mCRPC) receiving androgen deprivation therapy (ADT). Thirty patients will be enrolled, with the expectation that 20-25 will complete all follow-up measures.
Detailed description
The purpose of this trial is to evaluate the feasibility and adherence to a home-based 12 week exercise intervention in mCRPC patients receiving ADT. It will also examine if a home-based exercise intervention can improve muscle strength, body composition, physical function, cardiopulmonary function fatigue, and patient reported outcomes (fatigue, depression, quality of life (QoL)).
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm study with ~30 men being recruited and 20-25 who complete all aspects of the study.
| Arm | Type | Receives |
|---|---|---|
| Home-based Exercise | Experimental | Behavioral: Home-based exerciseThe sole intervention group will complete a combination of aerobic and strength training ~3 times per week for 12 weeks with each session lasting 1 hour. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Metastatic disease that has progressed despite castrate levels of testosterone (surgically or medically castrated, with testosterone levels of < 50 ng/dL) receiving ADT. This will be verified by assessing total testosterone levels within 4 weeks prior to enrollment.
- No current chemotherapy.
- Patients may be receiving additional hormonal therapy agents including but not limited to antiandrogens (e.g. bicalutamide, enzalutamide) and CYP17 inhibitors (e.g. abiraterone).
- Ability to engage safely in moderate exercise as determined by their treating physician.
- Not previously engaged in regular exercise training (<3 or more d/wk for > 30 min/d or <90 mins per week total including strength training, aerobic training, or walking) in the past 6 months.
Key exclusion criteria (10 listed)
- Any condition that causes severe pain with exertion.
- History of bone fractures.
- Active cardiovascular disease including any of the following:
- Acute or chronic respiratory disease that is severe enough to compromise the ability of the participant to safely engage in exercise training protocol.
- Acute or chronic bone/joint/muscular abnormalities compromising their ability to exercise.
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 |
|---|---|---|
| Home-based exerciseThe intervention consists of aerobic and strength training ~3 times per week for 12 weeks with each session lasting 1 hour. The progressive aerobic exercise will involve walking that varies from from 15 to 30 minutes done 2-4 times per week at an intensity from 40% to 65% of heart rate reserve. Therabands elastic bands will be used to perform 12 to 15 repetitions per exercise. Once a participant can comfortably complete 15 repetitions for all prescribed sets, they will increase resistance by moving up to the next band. The training volume increased from 1 set per exercise on week 1 to 3 sets by week 12. | Behavioural | Home-based Exercise |
Primary outcome
Percentage of Patients Who Complete the Pre/Post Exercise Intervention Testing.
Time frame: 12 weeks after baseline testing
To estimate the feasibility of a 12 week, home-based exercise intervention in metastatic castrate resistant prostate cancer (mCPRC) patients undergoing androgen deprivation therapy by reporting the percentage of patients who complete the pre/post testing following the intervention. This was calculated as the number of subjects who completed the trial compared to the total number who completed baseline testing.
19 secondary outcomes
Adherence to the Intervention
Time frame: 12 weeks after baseline testing
Physical Function: 6m Walk
Time frame: 12 weeks after baseline testing
Physical Function: Timed Up and Go
Time frame: 12 weeks after baseline testing
Physical Function: Stair Climb
Time frame: 12 weeks after baseline testing
Physical Function: 400m Walk
Time frame: 12 weeks after baseline testing
Patient Reported Outcomes: Fatigue
Time frame: 12 weeks after baseline testing
Patient Reported Outcomes: Quality of Life
Time frame: 12 weeks after baseline testing
Patient Reported Outcomes: Depression
Time frame: 12 weeks after baseline testing
Patient Reported Outcomes: Anxiety
Time frame: 12 weeks after baseline testing
Muscle Size (Cross-sectional Area)
Time frame: 12 weeks after baseline testing
Muscle Quality
Time frame: 12 weeks after baseline testing
Chest Press Maximal Strength
Time frame: 12 weeks after baseline testing
Chest Press Muscle Endurance
Time frame: 12 weeks after baseline testing
Leg Press Maximal Strength
Time frame: 12 weeks after baseline testing
Leg Press Muscle Endurance
Time frame: 12 weeks after baseline testing
Cardiopulmonary Function
Time frame: 12 weeks after baseline testing
Lean Mass
Time frame: 12 weeks after baseline testing
Fat Mass
Time frame: 12 weeks after baseline testing
Percent Body Fat
Time frame: 12 weeks after baseline testing
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Both sites (UNC and WF) are adding and storing data on a secure, centralized server. No individual data will be made available to protect the identity of the patients in the trial.
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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.
Erik D Hanson, PhD principal investigator
UNC-Chapel Hill
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based exercise in people with Castration-resistant Prostate Cancer and Androgen Deprivation Therapy, run by UNC Lineberger Comprehensive Cancer Center at 2 sites in United States.
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 7 inclusion and 10 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 20 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Yes. Results are posted in the registry (first posted 12 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Patients Who Complete the Pre/Post Exercise Intervention Testing. (time frame: 12 weeks after baseline testing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Apr 2021.