Trial Outcomes & Findings for Use of β-hydroxy-β-methylbutyrate to Counteract Muscle Loss in Men With Prostate Cancer on Androgen Ablation (NCT NCT01607879)

NCT ID: NCT01607879

Last Updated: 2023-09-22

Results Overview

This measure will be the change of lean body mass from baseline reported in kilograms.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 48 participants
• Primary outcome timeframe: Baseline, 3 months
• Results posted on: 2023-09-22

Participant Flow

Participant milestones

Measure	Standard of Care ADT + (HMB + AG) Standard of care androgen deprivation therapy plus the nutritional supplement HMB + arginine + glutamine (AG) Standard of care ADT + (HMB + arginine + glutamine): 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 ADT Standard of care androgen deprivation therapy Standard of care ADT: Patient will receive standard of care androgen deprivation therapy (ADT) alone
Overall Study STARTED	24	24
Overall Study COMPLETED	23	24
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Standard of Care ADT + (HMB + AG) Standard of care androgen deprivation therapy plus the nutritional supplement HMB + arginine + glutamine (AG) Standard of care ADT + (HMB + arginine + glutamine): 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 ADT Standard of care androgen deprivation therapy Standard of care ADT: Patient will receive standard of care androgen deprivation therapy (ADT) alone
Overall Study Death	1	0

Baseline Characteristics

Use of β-hydroxy-β-methylbutyrate to Counteract Muscle Loss in Men With Prostate Cancer on Androgen Ablation

Baseline characteristics by cohort

Measure	Standard of Care ADT + (HMB + AG) n=24 Participants Standard of care androgen deprivation therapy plus the nutritional supplement HMB + arginine + glutamine (AG) Standard of care ADT + (HMB + arginine + glutamine): 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 ADT n=24 Participants Standard of care androgen deprivation therapy Standard of care ADT: Patient will receive standard of care androgen deprivation therapy (ADT) alone	Total n=48 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	10 Participants n=7 Participants	13 Participants n=5 Participants
Age, Categorical >=65 years	21 Participants n=5 Participants	14 Participants n=7 Participants	35 Participants n=5 Participants
Age, Continuous	70.6 years STANDARD_DEVIATION 5.6 • n=5 Participants	67.4 years STANDARD_DEVIATION 5.1 • n=7 Participants	69.0 years STANDARD_DEVIATION 5.6 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	24 Participants n=7 Participants	48 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	23 Participants n=5 Participants	24 Participants n=7 Participants	47 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	24 Participants n=5 Participants	22 Participants n=7 Participants	46 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	24 participants n=5 Participants	24 participants n=7 Participants	48 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 3 months

This measure will be the change of lean body mass from baseline reported in kilograms.

Outcome measures

Measure	Standard of Care ADT + (HMB + AG) n=24 Participants Standard of care androgen deprivation therapy plus the nutritional supplement HMB + arginine + glutamine (AG) Standard of care ADT + (HMB + arginine + glutamine): 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 ADT n=24 Participants Standard of care androgen deprivation therapy Standard of care ADT: Patient will receive standard of care androgen deprivation therapy (ADT) alone
Change From Baseline in Body Composition (Lean Body Mass) Baseline	54.93 Kilogram Standard Deviation 8.66	57.58 Kilogram Standard Deviation 7.39
Change From Baseline in Body Composition (Lean Body Mass) Change from Baseline	-1.27 Kilogram Standard Deviation 1.42	-0.60 Kilogram Standard Deviation 2.22

SECONDARY outcome

Timeframe: Baseline and 3 months

Population: Due to unavailability of equipment, only 5 subjects in the HMB+AG group and 8 subjects in the standard ADT therapy group completed both baseline and 3 months follow-up measurements.

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.

Outcome measures

Measure	Standard of Care ADT + (HMB + AG) n=5 Participants Standard of care androgen deprivation therapy plus the nutritional supplement HMB + arginine + glutamine (AG) Standard of care ADT + (HMB + arginine + glutamine): 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 ADT n=8 Participants Standard of care androgen deprivation therapy Standard of care ADT: Patient will receive standard of care androgen deprivation therapy (ADT) alone
Change From Baseline of Dorsiflexor Muscle Size in mm^2. Baseline	1378 mm^2 Standard Deviation 322	1348 mm^2 Standard Deviation 177
Change From Baseline of Dorsiflexor Muscle Size in mm^2. Change at 3 months	-36 mm^2 Standard Deviation 37	30 mm^2 Standard Deviation 164

SECONDARY outcome

Timeframe: Baseline and 3 months

Population: Due to unavailability of equipment, only 5 subjects in the HMB+AG group and 10 subjects in the standard ADT group completed both baseline and 3 month follo-up visits.

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.

Outcome measures

Measure	Standard of Care ADT + (HMB + AG) n=5 Participants Standard of care androgen deprivation therapy plus the nutritional supplement HMB + arginine + glutamine (AG) Standard of care ADT + (HMB + arginine + glutamine): 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 ADT n=10 Participants Standard of care androgen deprivation therapy Standard of care ADT: Patient will receive standard of care androgen deprivation therapy (ADT) alone
Change From Baseline in Strength of the Dorsiflexor Muscle in Kilograms. Baseline	17.2 kilogram Standard Deviation 3.1	18.0 kilogram Standard Deviation 3.0
Change From Baseline in Strength of the Dorsiflexor Muscle in Kilograms. Change at 3 months	-1.0 kilogram Standard Deviation 5.3	1.0 kilogram Standard Deviation 2.0

SECONDARY outcome

Timeframe: Baseline and 3 months

Population: Four subjects in the HMB+AG group and one subject in the standard ADT group did not complete the SPPB test at the 3-month follow-up.

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.

Outcome measures

Measure	Standard of Care ADT + (HMB + AG) n=24 Participants Standard of care androgen deprivation therapy plus the nutritional supplement HMB + arginine + glutamine (AG) Standard of care ADT + (HMB + arginine + glutamine): 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 ADT n=24 Participants Standard of care androgen deprivation therapy Standard of care ADT: Patient will receive standard of care androgen deprivation therapy (ADT) alone
Physical Performance Measured Using the Short Physical Performance Battery (SPPB) Baseline	10.6 score on a scale Standard Deviation 1.6	10.7 score on a scale Standard Deviation 1.7
Physical Performance Measured Using the Short Physical Performance Battery (SPPB) 3 months	11.1 score on a scale Standard Deviation 1.1	11.0 score on a scale Standard Deviation 1.2

SECONDARY outcome

Timeframe: Baseline, 3 months

Population: Three subjects in the HMB+AG group did not report the number of falls at the 3-month follow-up.

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.

Outcome measures

Measure	Standard of Care ADT + (HMB + AG) n=24 Participants Standard of care androgen deprivation therapy plus the nutritional supplement HMB + arginine + glutamine (AG) Standard of care ADT + (HMB + arginine + glutamine): 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 ADT n=24 Participants Standard of care androgen deprivation therapy Standard of care ADT: Patient will receive standard of care androgen deprivation therapy (ADT) alone
Change From Baseline in the Number of Fall Events Baseline	1 Falls	0 Falls
Change From Baseline in the Number of Fall Events Change at 3 months	-1 Falls	0 Falls

Adverse Events

Standard of Care ADT + (HMB + AG)

Serious events: 1 serious events

Other events: 8 other events

Deaths: 1 deaths

Standard of Care ADT

Serious events: 2 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	Standard of Care ADT + (HMB + AG) n=24 participants at risk Standard of care androgen deprivation therapy plus the nutritional supplement HMB + arginine + glutamine (AG) Standard of care ADT + (HMB + arginine + glutamine): 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 ADT n=24 participants at risk Standard of care androgen deprivation therapy Standard of care ADT: Patient will receive standard of care androgen deprivation therapy (ADT) alone
Investigations Leukocytes decreased	0.00% 0/24 • 8 months	4.2% 1/24 • Number of events 1 • 8 months
General disorders Multi-organ failure	4.2% 1/24 • Number of events 1 • 8 months	0.00% 0/24 • 8 months
General disorders Transient ischemic attack	0.00% 0/24 • 8 months	4.2% 1/24 • Number of events 1 • 8 months

Other adverse events

Measure	Standard of Care ADT + (HMB + AG) n=24 participants at risk Standard of care androgen deprivation therapy plus the nutritional supplement HMB + arginine + glutamine (AG) Standard of care ADT + (HMB + arginine + glutamine): 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 ADT n=24 participants at risk Standard of care androgen deprivation therapy Standard of care ADT: Patient will receive standard of care androgen deprivation therapy (ADT) alone
Gastrointestinal disorders Anorexia	4.2% 1/24 • Number of events 1 • 8 months	0.00% 0/24 • 8 months
Musculoskeletal and connective tissue disorders Face pain	0.00% 0/24 • 8 months	4.2% 1/24 • Number of events 1 • 8 months
Musculoskeletal and connective tissue disorders Hand pain	4.2% 1/24 • Number of events 1 • 8 months	0.00% 0/24 • 8 months
Musculoskeletal and connective tissue disorders Joint pain	4.2% 1/24 • Number of events 1 • 8 months	8.3% 2/24 • Number of events 2 • 8 months
Musculoskeletal and connective tissue disorders Neck pain	4.2% 1/24 • Number of events 1 • 8 months	0.00% 0/24 • 8 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm - other	0.00% 0/24 • 8 months	4.2% 1/24 • Number of events 1 • 8 months
Nervous system disorders Dizziness	0.00% 0/24 • 8 months	4.2% 1/24 • Number of events 1 • 8 months
Nervous system disorders Headache	0.00% 0/24 • 8 months	4.2% 1/24 • Number of events 1 • 8 months
Nervous system disorders Transient ischemic event	4.2% 1/24 • Number of events 1 • 8 months	0.00% 0/24 • 8 months
Renal and urinary disorders Incontinence, Urinary	4.2% 1/24 • Number of events 1 • 8 months	0.00% 0/24 • 8 months
Renal and urinary disorders Urinary frequency/urgency	4.2% 1/24 • Number of events 1 • 8 months	4.2% 1/24 • Number of events 1 • 8 months
Renal and urinary disorders Urinary retention	4.2% 1/24 • Number of events 1 • 8 months	0.00% 0/24 • 8 months

Additional Information

Kathryn Bylow, MD

Froedtert and the Medical college of Wisconsin

Phone: 414-805-4600

Email: kbylow@mcw.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place