Trial · NCT01607879
Use of β-hydroxy-β-methylbutyrate to Counteract Muscle Loss in Men With Prostate Cancer on Androgen Ablation
NCT01607879, Phase 2, Completed, Medical College of Wisconsin; results first posted 2023-09-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Use of β-hydroxy-β-methylbutyrate to Counteract Muscle Loss in Men With Prostate Cancer on Androgen Ablation. Trials, record NCT01607879. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01607879
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Use of β-hydroxy-β-methylbutyrate to Counteract Muscle Loss in Men With Prostate Cancer on Androgen Ablation
- NCT number
- NCT01607879
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 48 participants, actual
- Lead sponsor
- Medical College of Wisconsin
- Conditions
- Prostate Cancer
- Interventions
- Standard of care ADT + (HMB + arginine + glutamine), Standard of care ADT
- First posted
- 2012-05-30
- Last updated
- 2023-09-22
- Results first posted
- 2023-09-22
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Body Composition (Lean Body Mass) | Baseline, 3 months | This measure will be the change of lean body mass from baseline reported in kilograms. |
| Secondary | Change From Baseline of Dorsiflexor Muscle Size in mm^2. | Baseline and 3 months | 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. |
| Secondary | Change From Baseline in Strength of the Dorsiflexor Muscle in Kilograms. | Baseline and 3 months | 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. |
| Secondary | Physical Performance Measured Using the Short Physical Performance Battery (SPPB) | Baseline and 3 months | 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. |
| Secondary | Change From Baseline in the Number of Fall Events | Baseline, 3 months | 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. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Body Composition (Lean Body Mass) | Baseline, 3 months | Kilogram | MEAN | |
| SECONDARY | Change From Baseline of Dorsiflexor Muscle Size in mm^2. | Baseline and 3 months | 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. | mm^2 | MEAN |
| SECONDARY | Change From Baseline in Strength of the Dorsiflexor Muscle in Kilograms. | Baseline and 3 months | 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. | kilogram | MEAN |
| SECONDARY | Physical Performance Measured Using the Short Physical Performance Battery (SPPB) | Baseline and 3 months | 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. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in the Number of Fall Events | Baseline, 3 months | Three subjects in the HMB+AG group did not report the number of falls at the 3-month follow-up. | Falls | NUMBER |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Body Composition (Lean Body Mass) | Standard of Care ADT + (HMB + AG) | Baseline | 54.93 | Standard Deviation 8.66 | Kilogram |
| Change From Baseline in Body Composition (Lean Body Mass) | Standard of Care ADT | Baseline | 57.58 | Standard Deviation 7.39 | Kilogram |
| Change From Baseline in Body Composition (Lean Body Mass) | Standard of Care ADT + (HMB + AG) | Change from Baseline | -1.27 | Standard Deviation 1.42 | Kilogram |
| Change From Baseline in Body Composition (Lean Body Mass) | Standard of Care ADT | Change from Baseline | -0.60 | Standard Deviation 2.22 | Kilogram |
| Change From Baseline of Dorsiflexor Muscle Size in mm^2. | Standard of Care ADT + (HMB + AG) | Baseline | 1378 | Standard Deviation 322 | mm^2 |
| Change From Baseline of Dorsiflexor Muscle Size in mm^2. | Standard of Care ADT | Baseline | 1348 | Standard Deviation 177 | mm^2 |
| Change From Baseline of Dorsiflexor Muscle Size in mm^2. | Standard of Care ADT + (HMB + AG) | Change at 3 months | -36 | Standard Deviation 37 | mm^2 |
| Change From Baseline of Dorsiflexor Muscle Size in mm^2. | Standard of Care ADT | Change at 3 months | 30 | Standard Deviation 164 | mm^2 |
| Change From Baseline in Strength of the Dorsiflexor Muscle in Kilograms. | Standard of Care ADT + (HMB + AG) | Baseline | 17.2 | Standard Deviation 3.1 | kilogram |
| Change From Baseline in Strength of the Dorsiflexor Muscle in Kilograms. | Standard of Care ADT | Baseline | 18.0 | Standard Deviation 3.0 | kilogram |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Standard of Care ADT + (HMB + AG) | 24 | |
| Overall Study | STARTED | Standard of Care ADT | 24 | |
| Overall Study | COMPLETED | Standard of Care ADT + (HMB + AG) | 23 | |
| Overall Study | COMPLETED | Standard of Care ADT | 24 | |
| Overall Study | NOT COMPLETED | Standard of Care ADT + (HMB + AG) | 1 | |
| Overall Study | NOT COMPLETED | Standard of Care ADT | 0 |
Source ClinicalTrials.gov
Adverse events30
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anorexia | Gastrointestinal disorders | Standard of Care ADT + (HMB + AG) | 1 | 24 | 1 |
| other | Anorexia | Gastrointestinal disorders | Standard of Care ADT | 0 | 24 | 0 |
| other | Face pain | Musculoskeletal and connective tissue disorders | Standard of Care ADT + (HMB + AG) | 0 | 24 | 0 |
| other | Face pain | Musculoskeletal and connective tissue disorders | Standard of Care ADT | 1 | 24 | 1 |
| other | Hand pain | Musculoskeletal and connective tissue disorders | Standard of Care ADT + (HMB + AG) | 1 | 24 | 1 |
| other | Hand pain | Musculoskeletal and connective tissue disorders | Standard of Care ADT | 0 | 24 | 0 |
| other | Joint pain | Musculoskeletal and connective tissue disorders | Standard of Care ADT + (HMB + AG) | 1 | 24 | 1 |
| other | Joint pain | Musculoskeletal and connective tissue disorders | Standard of Care ADT | 2 | 24 | 2 |
| other | Neck pain | Musculoskeletal and connective tissue disorders | Standard of Care ADT + (HMB + AG) | 1 | 24 | 1 |
| other | Neck pain | Musculoskeletal and connective tissue disorders | Standard of Care ADT | 0 | 24 | 0 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Standard of Care ADT + (HMB + AG) | 1 | 24 |
| Total, all-cause mortality | Standard of Care ADT | 0 | 24 |
| Total, other adverse events | Standard of Care ADT + (HMB + AG) | 8 | 24 |
| Total, other adverse events | Standard of Care ADT | 7 | 24 |
| Total, serious adverse events | Standard of Care ADT + (HMB + AG) | 1 | 24 |
| Total, serious adverse events | Standard of Care ADT | 2 | 24 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 10811152 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Standard of Care ADT + (HMB + AG) vs Standard of Care ADT: deaths from any cause | Trial comparisons |
| Standard of Care ADT + (HMB + AG) vs Standard of Care ADT: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01607879
GET https://conductscience.org/api/trials/v1/NCT01607879/events?page=2