Prostate Cancer Clinical Trial
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
Verified date | September 2023 |
Source | Medical College of Wisconsin |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 48 |
Est. completion date | February 16, 2021 |
Est. primary completion date | July 2018 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 60 Years and older |
Eligibility | Inclusion Criteria: 1. Histologically confirmed adenocarcinoma of the prostate 2. Age 60 years or older 3. 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 4. Patient able to give informed consent. Exclusion Criteria: 1. Patient already on ADT 2. Patients who are visiting clinic for a second opinion only 3. Patients with a diagnosis of dementia 4. Patients with a diagnosis of a neuromuscular disorder (i.e. multiple sclerosis) |
Country | Name | City | State |
---|---|---|---|
United States | Froedtert Hospital and the Medical College of Wisconsin | Milwaukee | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
Medical College of Wisconsin |
United States,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change From Baseline in Body Composition (Lean Body Mass) | This measure will be the change of lean body mass from baseline reported in kilograms. | Baseline, 3 months | |
Secondary | 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. | Baseline and 3 months | |
Secondary | 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. | Baseline and 3 months | |
Secondary | 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. |
Baseline and 3 months | |
Secondary | 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. | Baseline, 3 months |
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