Prostate CancerPhase 2NCT01607879
Use of β-hydroxy-β-methylbutyrate to Counteract Muscle Loss in Men With Prostate Cancer on Androgen Ablation
A Phase 2 study of Prostate Cancer, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
This is a study of HMB plus amino acids in older men with prostate cancer starting androgen deprivation therapy (ADT). The investigators hypothesize that the use of this nutritional supplementation will decrease the loss of muscle mass and strength that occurs when men start ADT. Read more about this study
- Who is it for?
- Ages 60 years and older, men only
- Conditions the study is for
- Prostate Cancer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to 16 Feb 2021
- Phase
- Phase 2
- 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 60 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed adenocarcinoma of the prostate
- Age 60 years or older
- Patients with asymptomatic or minimally symptomatic prostate cancer for which they are about to start androgen deprivation therapy (ADT) per provider recommendation
- Asymptomatic or minimally symptomatic (as judged by treating physician) metastases allowed
- Men receiving ADT for localized prostate cancer are allowed
- Patient able to give informed consent.
Who cannot join
- Patient already on ADT
- Patients who are visiting clinic for a second opinion only
- Patients with a diagnosis of dementia
- Patients with a diagnosis of a neuromuscular disorder (i.e. multiple sclerosis)
Trial locations and contacts
1 site in 1 country.
United States1 site
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: Use of β-hydroxy-β-methylbutyrate to Counteract Loss of Muscle Mass and Strength in Older Men With Prostate Cancer Started on Androgen Deprivation Therapy
This is a study of HMB plus amino acids in older men with prostate cancer starting androgen deprivation therapy (ADT). The investigators hypothesize that the use of this nutritional supplementation will decrease the loss of muscle mass and strength that occurs when men start ADT.
Read the detailed description
It is well established that older patients experience age-related loss of muscle mass and function (sarcopenia), presumably due to an imbalance of protein synthesis versus protein breakdown. In addition, studies have shown that men who start on ADT experience increased muscle protein breakdown and decreased synthesis. β-hydroxy-β-methylbutyrate (HMB), a leucine metabolite, has been shown to slow protein breakdown. When HMB is given with arginine and lysine (which support protein synthesis) in randomized trials, researchers have shown that elderly men and women who receive this nutritional supplementation experience improvement in fat-free mass, strength, functionality and protein synthesis when compared with controls. In addition, patients with advanced cancer who experienced weight loss of at least 5% have also been shown to benefit from HMB, with supplementation resulting in a significant increase of fat-free mass when compared to controls. Thus, it seems reasonable that older men with prostate cancer starting on ADT who experience lean muscle loss as a result of aging and ADT, may achieve some benefit from supplementation with HMB as well. Use of HMB in men with prostate cancer has not been reported.
- Conditions
- Prostate Cancer
- Being tested
- Standard of care ADT + (HMB + arginine + glutamine), Standard of care ADT
- Keywords
- Prostate Cancer, Men, Androgen Deprivation Therapy, Elderly, Geriatric, Nutritional supplementation
- Medical subject headings
- Prostatic Neoplasms, Multiple Endocrine Neoplasia Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of care ADT + (HMB + arginine + glutamine)Drug
Also called Juven
1 packet of HMB+arginine+glutamine contains 1.5 g of the amino acid metabolite HMB + 7 g arginine and 7 g glutamine.
Take one packet twice daily for 3 months
Standard of care ADTOther
Also called Standard of care androgen deprivation therapy (ADT)
Patient will receive standard of care androgen deprivation therapy (ADT) alone
| Study group | Role | What they receive |
|---|---|---|
| Standard of care ADT + (HMB + AG) | Experimental | Standard of care androgen deprivation therapy plus the nutritional supplement HMB + arginine + glutamine (AG) Receives: Drug: Standard of care ADT + (HMB + arginine + glutamine) |
| Standard of care ADT | Active comparator | Standard of care androgen deprivation therapy Receives: Other: Standard of care ADT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Body Composition (Lean Body Mass)
This measure will be the change of lean body mass from baseline reported in kilograms.
Measured: Baseline, 3 months
Secondary outcomes (4)
Change From Baseline of Dorsiflexor Muscle Size in mm^2.
Cross-sectional area of the dorsiflexor muscle will be measured in mm^2 using magnetic resonance imaging. The dorsiflexor muscles at the front of the leg are responsible for lifting the ball of the foot with the heel in contact with the ground. One dorsiflexor muscle in one leg was analyzed per participant.
Measured: Baseline and 3 months
Change From Baseline in Strength of the Dorsiflexor Muscle in Kilograms.
Dorsiflexor muscle strength in kilograms will be measured with a custom lower leg ergometer. The dorsiflexor muscles at the front of the leg are responsible for lifting the ball of the foot with the heel in contact with the ground.
Measured: Baseline and 3 months
Physical Performance Measured Using the Short Physical Performance Battery (SPPB)
The SPPB uses Likert-style ratings for balance, walking speed, and standing test (Guralnik, 2000).
Balance metric is the ability to hold three standing positions (feet side-by-side; side of the heel of one foot touching the big toe of the other foot; heel of one foot in front of and touching the toes of the other) up to 10 seconds. Inability to hold a position scores '0'. The sum of scores is the Balance Score. Scoring range is 0-4. Higher scores indicate better balance.
Walking metric is time to walk 8 feet. Faster times score more points. Inability to complete the walk scores '0'. The score range is 0-4. Higher scores indicate better mobility.
The Standing Test. The subject is asked to stand and sit five times as quickly as possible. Inability to complete five repetitions scores '0'. Shorter times score more points. Scoring range is 0-4. Higher scores indicate better mobility.
Overall score is the sum of the scores ranging 0 to 12. Higher scores indicate better performance.
Measured: Baseline and 3 months
Change From Baseline in the Number of Fall Events
This measure will be the change in the number of reported falls from baseline (defined as the 3 months preceding the baseline visit), and the 3 month period beginning after the baseline visit and continuing through 3 months of therapy.
Measured: Baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2012 (estimated)
- Study startMar 2014
- Primary completionJul 2018
- Study completion16 Feb 2021
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kathryn A Bylow, MD, Medical College of Wisconsin
- Investigators
- Kathryn Bylow, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01607879
- Sponsor's protocol ID
- 00016781
- Status last verified
- Sep 2023
- First submitted
- 20 Apr 2012
- Last updated
- 22 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Guralnik JM, Ferrucci L, Pieper CF, Leveille SG, Markides KS, Ostir GV, Studenski S, Berkman LF, Wallace RB. Lower extremity function and subsequent disability: consistency across studies, predictive models, and value of gait speed alone compared with the short physical performance battery. J Gerontol A Biol Sci Med Sci. 2000 Apr;55(4):M221-31. doi: 10.1093/gerona/55.4.m221.
PubMed 10811152
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of β-hydroxy-β-methylbutyrate to Counteract Loss of Muscle Mass and Strength in Older Men With Prostate Cancer Started on Androgen Deprivation Therapy
- ClinicalTrials.gov ID
- NCT01607879
- Acronym / sponsor ID
- 00016781
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Men, Androgen Deprivation Therapy, Elderly, Geriatric, Nutritional supplementation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Jul 2018 (actual)
- Study completion
- 16 Feb 2021 (actual)
- First posted
- 30 May 2012 (estimated)
- Results
- Posted 22 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study of HMB plus amino acids in older men with prostate cancer starting androgen deprivation therapy (ADT). The investigators hypothesize that the use of this nutritional supplementation will decrease the loss of muscle mass and strength that occurs when men start ADT.
Detailed description
It is well established that older patients experience age-related loss of muscle mass and function (sarcopenia), presumably due to an imbalance of protein synthesis versus protein breakdown. In addition, studies have shown that men who start on ADT experience increased muscle protein breakdown and decreased synthesis. β-hydroxy-β-methylbutyrate (HMB), a leucine metabolite, has been shown to slow protein breakdown. When HMB is given with arginine and lysine (which support protein synthesis) in randomized trials, researchers have shown that elderly men and women who receive this nutritional supplementation experience improvement in fat-free mass, strength, functionality and protein synthesis when compared with controls. In addition, patients with advanced cancer who experienced weight loss of at least 5% have also been shown to benefit from HMB, with supplementation resulting in a significant increase of fat-free mass when compared to controls. Thus, it seems reasonable that older men with prostate cancer starting on ADT who experience lean muscle loss as a result of aging and ADT, may achieve some benefit from supplementation with HMB as well. Use of HMB in men with prostate cancer has not been reported.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care ADT + (HMB + AG) | Experimental | Drug: Standard of care ADT + (HMB + arginine + glutamine)Standard of care androgen deprivation therapy plus the nutritional supplement HMB + arginine + glutamine (AG) |
| Standard of care ADT | Active comparator | Other: Standard of care ADTStandard of care androgen deprivation therapy |
Who may qualify
- Ages
- 60 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically confirmed adenocarcinoma of the prostate
- Age 60 years or older
- Patients with asymptomatic or minimally symptomatic prostate cancer for which they are about to start androgen deprivation therapy (ADT) per provider recommendation
- Patient able to give informed consent.
Key exclusion criteria (4 listed)
- Patient already on ADT
- Patients who are visiting clinic for a second opinion only
- Patients with a diagnosis of dementia
- Patients with a diagnosis of a neuromuscular disorder (i.e. multiple sclerosis)
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 |
|---|---|---|
| Standard of care ADT + (HMB + arginine + glutamine)Also: Juven1 packet of HMB+arginine+glutamine contains 1.5 g of the amino acid metabolite HMB + 7 g arginine and 7 g glutamine. Take one packet twice daily for 3 months | Drug | Standard of care ADT + (HMB + AG) |
| Standard of care ADTAlso: Standard of care androgen deprivation therapy (ADT)Patient will receive standard of care androgen deprivation therapy (ADT) alone | Other | Standard of care ADT |
Primary outcome
Change From Baseline in Body Composition (Lean Body Mass)
Time frame: Baseline, 3 months
This measure will be the change of lean body mass from baseline reported in kilograms.
4 secondary outcomes
Change From Baseline of Dorsiflexor Muscle Size in mm^2.
Time frame: Baseline and 3 months
Change From Baseline in Strength of the Dorsiflexor Muscle in Kilograms.
Time frame: Baseline and 3 months
Physical Performance Measured Using the Short Physical Performance Battery (SPPB)
Time frame: Baseline and 3 months
Change From Baseline in the Number of Fall Events
Time frame: Baseline, 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 10811152Guralnik JM, Ferrucci L, Pieper CF, Leveille SG, Markides KS, Ostir GV, Studenski S, Berkman LF, Wallace RB. Lower extremity function and subsequent disability: consistency across studies, predictive models, and value of gait speed alone compared with the short physical performance battery. J Gerontol A Biol Sci Med Sci. 2000 Apr;55(4):M221-31. doi: 10.1093/gerona/55.4.m221.
- 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.
Kathryn Bylow, MD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Prostate Cancer, run by Medical College of Wisconsin at 1 site 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 6 inclusion and 4 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 22 Sep 2023. 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 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Sep 2023). 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?
Change From Baseline in Body Composition (Lean Body Mass) (time frame: Baseline, 3 months). 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 NCT01607879, which also lists 1 linked publication.
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 22 Sep 2023.