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BurnsPhase 2/3NCT00675714

Assessment of the Treatment of Severely Burned With Anabolic Agents on Clinical Outcomes, Recovery and Rehabilitation

A Phase 2/3 study testing Stable Isotope Infusion Study, Collection of blood and tissues and Radiology testing: Dual-energy X-ray absorptiometry (DEXA), ultrasound, MRI in people with Burns, run by The University of Texas Medical Branch, Galveston at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of the program is to study and characterize the outcome of burn injury with particular attention to improving the rehabilitation of burn survivors, including children. Read more about this study

Who is it for?
Ages Up to 80 years
Conditions the study is for
Burns
What is being tested?
Stable Isotope Infusion Study, Collection of blood and tissues and Radiology testing: Dual-energy X-ray absorptiometry (DEXA), ultrasound, MRI
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,126 participants
Where
1 siteUnited States
Study dates
Jan 2004to 15 Jul 2019
Phase
Phase 2/3
Are there results?
None posted in the registry

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 Up to 80 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Burn 30% Total Body Surface Area (TBSA) or greater
  • Ages 0-80 yrs
  • Negative pregnancy test
  • Informed consent

Who cannot join

  • Untreated malignancy, known history of AIDS, Aids Related Complex, HIV
  • Recent history of myocardial infarction (6 wks)
  • Tuberculosis, arthritis, cirrhosis, hyperlipidemia, bone or endocrine diseases, autoimmune diseases
  • Chronic glucocorticoid or non steroidal anti inflammatory drug therapy
  • Diabetes mellitus prior to burn injury
  • Renal insufficiency (defined by creatinine >3.0 mg/dl)
  • Hepatic disease (bilirubin > 3.0 mg/dl)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Texas Medical Branch

    Galveston, Texas, 77551

Other trials in United States

About this study

Official title: Assessment of the Treatment of the Severely Burned With Anabolic Agents on Clinical Outcomes, Recovery and Rehabilitation

The purpose of the program is to study and characterize the outcome of burn injury with particular attention to improving the rehabilitation of burn survivors, including children. Various agents are assessed for effectiveness on long term burn outcome, such as growth hormone, oxandrolone, propranolol,ketoconazole, inhospital exercise and home exercise.

Read the detailed description

The University of Texas Medical Branch(UTMB) project improves outcomes for severely burned children by instituting and evaluating two modifications to traditional rehabilitation: (1) an intensive rehabilitation program including active resistance exercise; (2) long term administration of anabolic agents.

Effectiveness is assessed by comparison with functional outcomes achieved in traditional outpatient rehabilitation programs. Results indicate improvement in strength, endurance and bone density with these modifications. The project also maintains a longitudinal database that includes measures of cardiopulmonary function, growth and maturation, bone density, range of motion, and psychosocial adjustment.

Conditions
Burns
Being tested
Stable Isotope Infusion Study, Collection of blood and tissues, Radiology testing: Dual-energy X-ray absorptiometry (DEXA), ultrasound, MRI, Humatrope, Ketoconazole
Keywords
anabolic agents, exercise
Medical subject headings
Burns, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stable Isotope Infusion StudyProcedure or surgery

    1-8 hour stable isotope infusion study to be done following each surgery. Tagged isotopes to assess uptake into blood and tissues.

  • Collection of blood and tissuesProcedure or surgery

    Blood draw with each stable isotope infusion study and weekly Tissue biopsy: skin, fat, muscle at stable isotope infusion study

  • Radiology testing: Dual-energy X-ray absorptiometry (DEXA), ultrasound, MRIProcedure or surgery

    Testing to be done following every stable isotope infusion study to measure muscle, fat and bone tissues.

  • HumatropeDrug

    Also called recombinant human growth hormone, Growth Hormone

    Humatrope (Growth Hormone) dose:0.05mg - 0.2mg/kg/day SQ daily for up to 2 years post burn injury.

  • KetoconazoleDrug

    Also called itraconazole, fluconazole

    Ketoconazole administration (or other glucocorticoid blocker--itraconazole or fluconazole) PO daily for up to 2 years post burn injury

  • OxandroloneDrug

    Also called testosterone, nandrolone

    oxandrolone (or other anabolic steroid-testosterone or nandrolone) daily for up to 2 years post burn injury

  • PropranololDrug

    Also called metoprolol, inderol

    Propranolol (or other beta adrenergic blocker--metoprolol, inderol), PO administration daily for up to 2 years post burn injury.

  • Oxandrolone and propranolol combinedDrug

    Also called testosterone, nandrolone, inderol, metoprolol

    Daily administration of oxandrolone and propranolol to be given for up to 2 years post burn injury.

  • Humatrope and propranolol combinedDrug

    Also called recombinant human growth hormone, Growth Hormone, inderol, metoprolol

    Humatrope (growth hormone) and propranolol administration daily for up to 2 years post burn injury.

  • PlaceboDrug

    Also called control

    placebo to be given once a day for up to two years post burn injury.

  • Exercise--Hospital supervised intensive exercise programBehavioural

    Also called exercise, intensive exercise, aerobic exercise, exercise rehabilitation program

    intensive exercise program supervised by trained personnel in the hospital environment for six up to twelve week program.

  • Home exercise programBehavioural

    Also called Home exercise, intensive exercise, exercise rehabilitation

    Home intensive exercise program: training occurs in hospital then patient sent home to continue exercise program for six weeks and up to 12 weeks at home.

Study groups in NCT00675714
Study groupRoleWhat they receive
1ExperimentalHumatrope subcutaneous(SQ) 0.05-0.2 mg/kg/day for up to 2 years post burn
Receives: Procedure: Stable Isotope Infusion Study; Procedure: Collection of blood and tissues; Procedure: Radiology testing: Dual-energy X-ray absorptiometry (DEXA), ultrasound, MRI; Drug: Humatrope
2ExperimentalKetoconazole by mouth (PO) given twice a day throughout hospitalization for up to 2 years post burn
Receives: Procedure: Stable Isotope Infusion Study; Procedure: Collection of blood and tissues; Procedure: Radiology testing: Dual-energy X-ray absorptiometry (DEXA), ultrasound, MRI; Drug: Ketoconazole
3ExperimentalOxandrolone PO given daily throughout hospitalization for up to 2 years post burn
Receives: Procedure: Stable Isotope Infusion Study; Procedure: Collection of blood and tissues; Procedure: Radiology testing: Dual-energy X-ray absorptiometry (DEXA), ultrasound, MRI; Drug: Oxandrolone
4ExperimentalPropranolol PO given daily throughout hospitalization for up to 2 years post burn
Receives: Procedure: Stable Isotope Infusion Study; Procedure: Collection of blood and tissues; Procedure: Radiology testing: Dual-energy X-ray absorptiometry (DEXA), ultrasound, MRI; Drug: Propranolol
5ExperimentalOxandrolone and propranolol PO to be given daily for up to 2 years post burn
Receives: Procedure: Stable Isotope Infusion Study; Procedure: Collection of blood and tissues; Procedure: Radiology testing: Dual-energy X-ray absorptiometry (DEXA), ultrasound, MRI; Drug: Oxandrolone and propranolol combined
6ExperimentalHumatrope SQ and Propranolol PO to be given daily for up to 2 years post burn
Receives: Procedure: Stable Isotope Infusion Study; Procedure: Collection of blood and tissues; Procedure: Radiology testing: Dual-energy X-ray absorptiometry (DEXA), ultrasound, MRI; Drug: Humatrope and propranolol combined
7Placebo comparatorPlacebo PO to be given for up to 2 years post burn
Receives: Procedure: Stable Isotope Infusion Study; Procedure: Collection of blood and tissues; Procedure: Radiology testing: Dual-energy X-ray absorptiometry (DEXA), ultrasound, MRI; Drug: Placebo
8ExperimentalExercise--hospital supervised intensive exercise program
Receives: Procedure: Stable Isotope Infusion Study; Procedure: Collection of blood and tissues; Procedure: Radiology testing: Dual-energy X-ray absorptiometry (DEXA), ultrasound, MRI; Behavioral: Exercise--Hospital supervised intensive exercise program
9ExperimentalExercise--home or community based exercise program
Receives: Procedure: Stable Isotope Infusion Study; Procedure: Collection of blood and tissues; Procedure: Radiology testing: Dual-energy X-ray absorptiometry (DEXA), ultrasound, MRI; Behavioral: Home exercise program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Measures of muscle wasting, weakness, immunosuppression chronic bone loss and decreased growth with increases in metabolic, hemodynamic, inflammatory and scarring responses.

    Dual Energy X-Ray Absorptiometry measurements will be utilized to measure muscle wasting

    Measured: Admission to burn unit and up to 2 years post burn and yearly after that

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2008 (estimated)
  2. Study startJan 2004
  3. Primary completionSep 2018
  4. Study completion15 Jul 2019

Why it stopped: At the request of the study site, this study has been closed and access to study-related data is unavailable. We are unable to submit the results-data.

Resources

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,126 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00675714
Sponsor's protocol ID
04-157
Other IDs
NIDILRR 90DP0043-03-00, P50GM060338
Status last verified
Aug 2018
First submitted
26 Dec 2007
Last updated
29 Nov 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Alloju SM, Herndon DN, McEntire SJ, Suman OE. Assessment of muscle function in severely burned children. Burns. 2008 Jun;34(4):452-9. doi: 10.1016/j.burns.2007.10.006. Epub 2008 Feb 20.

    PubMed 18243565

  • Guillory AN, Herndon DN, Silva MB 3rd, Andersen CR, Suman OE, Finnerty CC. Oxandrolone Coadministration Does Not Alter Plasma Propranolol Concentrations in Severely Burned Pediatric Patients. J Burn Care Res. 2017 Jul/Aug;38(4):243-250. doi: 10.1097/BCR.0000000000000494.

    PubMed 28240622

  • Herndon DN, Voigt CD, Capek KD, Wurzer P, Guillory A, Kline A, Andersen CR, Klein GL, Tompkins RG, Suman OE, Finnerty CC, Meyer WJ, Sousse LE. Reversal of Growth Arrest With the Combined Administration of Oxandrolone and Propranolol in Severely Burned Children. Ann Surg. 2016 Sep;264(3):421-8. doi: 10.1097/SLA.0000000000001844.

    PubMed 27433905

  • Sousse LE, Herndon DN, Mlcak RP, Lee JO, Andersen CR, Zovath AJ, Finnerty CC, Suman OE. Long-Term Administration of Oxandrolone Improves Lung Function in Pediatric Burned Patients. J Burn Care Res. 2016 Sep-Oct;37(5):273-7. doi: 10.1097/BCR.0000000000000356.

    PubMed 27171844

  • Diaz EC, Herndon DN, Lee J, Porter C, Cotter M, Suman OE, Sidossis LS, Borsheim E. Predictors of muscle protein synthesis after severe pediatric burns. J Trauma Acute Care Surg. 2015 Apr;78(4):816-22. doi: 10.1097/TA.0000000000000594.

    PubMed 25807408

  • Kraft R, Herndon DN, Finnerty CC, Cox RA, Song J, Jeschke MG. Predictive Value of IL-8 for Sepsis and Severe Infections After Burn Injury: A Clinical Study. Shock. 2015 Mar;43(3):222-7. doi: 10.1097/SHK.0000000000000294.

    PubMed 25514427

  • Patel P, Sallam HS, Ali A, Chandalia M, Suman O, Finnerty CC, Herndon DN, Abate N. Changes in fat distribution in children following severe burn injury. Metab Syndr Relat Disord. 2014 Dec;12(10):523-6. doi: 10.1089/met.2014.0098. Epub 2014 Sep 11.

    PubMed 25211297

  • Chondronikola M, Meyer WJ, Sidossis LS, Ojeda S, Huddleston J, Stevens P, Borsheim E, Suman OE, Finnerty CC, Herndon DN. Predictors of insulin resistance in pediatric burn injury survivors 24 to 36 months postburn. J Burn Care Res. 2014 Sep-Oct;35(5):409-15. doi: 10.1097/BCR.0000000000000017.

    PubMed 24918945

  • Hardee JP, Porter C, Sidossis LS, Borsheim E, Carson JA, Herndon DN, Suman OE. Early rehabilitative exercise training in the recovery from pediatric burn. Med Sci Sports Exerc. 2014 Sep;46(9):1710-6. doi: 10.1249/MSS.0000000000000296.

    PubMed 24824900

  • Finnerty CC, Ali A, McLean J, Benjamin N, Clayton RP, Andersen CR, Mlcak RP, Suman OE, Meyer W, Herndon DN. Impact of stress-induced diabetes on outcomes in severely burned children. J Am Coll Surg. 2014 Apr;218(4):783-95. doi: 10.1016/j.jamcollsurg.2014.01.038. Epub 2014 Jan 24.

    PubMed 24655871

  • Finnerty CC, Herndon DN. Is propranolol of benefit in pediatric burn patients? Adv Surg. 2013;47:177-97. doi: 10.1016/j.yasu.2013.02.001. No abstract available.

    PubMed 24298851

  • Finnerty CC, Mabvuure NT, Ali A, Kozar RA, Herndon DN. The surgically induced stress response. JPEN J Parenter Enteral Nutr. 2013 Sep;37(5 Suppl):21S-9S. doi: 10.1177/0148607113496117.

    PubMed 24009246

  • Ray S, Ju X, Sun H, Finnerty CC, Herndon DN, Brasier AR. The IL-6 trans-signaling-STAT3 pathway mediates ECM and cellular proliferation in fibroblasts from hypertrophic scar. J Invest Dermatol. 2013 May;133(5):1212-20. doi: 10.1038/jid.2012.499. Epub 2013 Jan 10.

    PubMed 23303450

  • Kraft R, Herndon DN, Finnerty CC, Hiyama Y, Jeschke MG. Association of postburn fatty acids and triglycerides with clinical outcome in severely burned children. J Clin Endocrinol Metab. 2013 Jan;98(1):314-21. doi: 10.1210/jc.2012-2599. Epub 2012 Nov 12.

    PubMed 23150682

  • Herndon DN, Rodriguez NA, Diaz EC, Hegde S, Jennings K, Mlcak RP, Suri JS, Lee JO, Williams FN, Meyer W, Suman OE, Barrow RE, Jeschke MG, Finnerty CC. Long-term propranolol use in severely burned pediatric patients: a randomized controlled study. Ann Surg. 2012 Sep;256(3):402-11. doi: 10.1097/SLA.0b013e318265427e.

    PubMed 22895351

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Stable Isotope Infusion Study, Collection of blood and tissues and Radiology testing: Dual-energy X-ray absorptiometry (DEXA), ultrasound, MRI in people with Burns, run by The University of Texas Medical Branch, Galveston 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 4 inclusion and 7 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: stopped early, as of the sponsor's last update on 29 Nov 2019. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: At the request of the study site, this study has been closed and access to study-related data is unavailable. We are unable to submit the results-data.). Results are not available in the source record.

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?

Measures of muscle wasting, weakness, immunosuppression chronic bone loss and decreased growth with increases in metabolic, hemodynamic, inflammatory and scarring responses. (time frame: Admission to burn unit and up to 2 years post burn and yearly after that). 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 NCT00675714, which also lists 19 linked publications.

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 29 Nov 2019.

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