Parenteral Nutrition (No Primary Condition Studied)Phase 4NCT01923480
Dosing Study of Amino Acids in Seriously Ill Patients
A Phase 4 study testing 15% CLINISOL - Sulfite-free (Amino Acid) Injection in people with Parenteral Nutrition (No Primary Condition Studied), run by Baxter Healthcare Corporation at 2 sites in United States.
Trial summary
The purpose of this study is to determine the best rate of infusion of amino acids (15% CLINISOL - sulfite-free (Amino Acid) Injection) for nutrition in subjects with with stages II to IVB head and neck cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parenteral Nutrition (No Primary Condition Studied)
- What is being tested?
- 15% CLINISOL - Sulfite-free (Amino Acid) Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2013to Dec 2014
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have Stages II to IVB head and neck cancer receiving radiation and may also be receiving chemotherapy.
- Subjects are eligible for inclusion in the study regardless of primary Stages II to IVB head and neck cancer treatment modality (eg, surgery, chemotherapy).
- Have voluntarily signed and dated a written informed consent form (ICF) after the nature of the study was explained to them.
- Female subjects must be of non childbearing potential (defined as postmenopausal for at least 1 year or surgically sterile [bilateral tubal ligation, bilateral oophorectomy or hysterectomy]) or;
- Female subjects of childbearing potential must be using adequate contraception (practicing 1 of the following methods of birth control):
- total abstinence from sexual intercourse (minimum of 1 complete menstrual cycle before study entry),
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- a vasectomized partner,
- contraceptives (oral, parenteral, or transdermal) for 3 consecutive months prior to study drug administration,
- intrauterine device (IUD), or
- double barrier method (condoms, sponge, diaphragm, or vaginal ring with spermicidal jellies or cream).
- Female subjects must have a negative serum or urinary pregnancy test result at screening (serum specimen must be obtained within 14 days prior to baseline).
Who cannot join
- Had a loss of > 10% of body weight within the 3 month period prior to the study as noted in the subjects medical history chart.
- Have renal disease as determined by an estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m2.
- Have a hemoglobin level of < 9 g/dl.
- Have Stage 0, I, or IVC metastatic cancer.
- Have diabetes.
- Have any reason which, in the opinion of the Investigator, would prevent the subject from safely participating in the study.
- Have, in the opinion of the Investigator, a dependence on alcohol.
- Have, in the opinion of the Investigator, a dependence on illicit drugs.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Texas A&M University, Center for Translational Research in Aging & Longevity
College Station, Texas, 77843-4253
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
Official title: Determination of the Optimal Infusion Rate of Amino Acids in Seriously Ill Patients
The purpose of this study is to determine the best rate of infusion of amino acids (15% CLINISOL - sulfite-free (Amino Acid) Injection) for nutrition in subjects with with stages II to IVB head and neck cancer.
- Being tested
- 15% CLINISOL - Sulfite-free (Amino Acid) Injection
- Medical subject headings
- Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
15% CLINISOL - Sulfite-free (Amino Acid) InjectionDrug
15% CLINISOL - Sulfite-free (Amino Acid) InjectionDrug
15% CLINISOL - Sulfite-free (Amino Acid) InjectionDrug
| Study group | Role | What they receive |
|---|---|---|
| 15% CLINISOL 0.04 g/kg/hr | Experimental | 15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection. Receives: Drug: 15% CLINISOL - Sulfite-free (Amino Acid) Injection |
| 15% CLINISOL 0.08 g/kg/hr | Experimental | 15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection. Receives: Drug: 15% CLINISOL - Sulfite-free (Amino Acid) Injection |
| 15% CLINISOL 0.13 g/kg/hr | Experimental | 15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection. Receives: Drug: 15% CLINISOL - Sulfite-free (Amino Acid) Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Net Protein Synthesis
Measured: One time at pre-clinisol infusion and one time at post-clinisol infusion
Secondary outcomes (24)
Insulin Sensitivity
Measured: Five times during each 7 hour visit
Plasma Concentration of Glucose
Measured: Nine times during each 7 hour visit
Serum Concentration of Insulin
Measured: Five times during each 7 hour visit
Plasma Stable Isotope Enrichment of Phenylalanine
Measured: Twelve times during each 7 hour visit
Plasma Stable Isotope Enrichment of Tyrosine
Measured: Twelve times during each 7 hour visit
Plasma Concentration of Alanine
Measured: Three times during each 7 hour visit
Plasma Concentration of Arginine
Measured: Three times during each 7 hour visit
Plasma Concentration of Aspartic Acid
Measured: Three times during each 7 hour visit
Plasma Concentration of Glutamic Acid
Measured: Three times during each 7 hour visit
Plasma Concentration of Glutamine
Measured: Three times during each 7 hour visit
Plasma Concentration of Glycine
Measured: Three times during each 7 hour visit
Plasma Concentration of Histidine
Measured: Three times during each 7 hour visit
Plasma Concentration of Isoleucine
Measured: Three times during each 7 hour visit
Plasma Concentration of Leucine
Measured: Three times during each 7 hour visit
Plasma Concentration of Lysine
Measured: Three times during each 7 hour visit
Plasma Concentration of Methionine
Measured: Three times during each 7 hour visit
Plasma Concentration of Ornithine
Measured: Three times during each 7 hour visit
Plasma Concentration of Phenylalanine
Measured: Three times during each 7 hour visit
Plasma Concentration of Proline
Measured: Three times during each 7 hour visit
Plasma Concentration of Serine
Measured: Three times during each 7 hour visit
Plasma Concentration of Taurine
Measured: Three times during each 7 hour visit
Plasma Concentration of Threonine
Measured: Three times during each 7 hour visit
Plasma Concentration of Tyrosine
Measured: Three times during each 7 hour visit
Plasma Concentration of Valine
Measured: Three times during each 7 hour visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2013 (estimated)
- Study startJul 2013
- Primary completionDec 2014
- Study completionDec 2014
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.
- Other trials for Parenteral Nutrition (No Primary Condition Studied)Studies of the same condition, open and under way.
- 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baxter Healthcare Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01923480
- Sponsor's protocol ID
- CT-12-0012
- Status last verified
- Feb 2016
- First submitted
- 13 Aug 2013
- Last updated
- 27 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Optimal Infusion Rate of Amino Acids in Seriously Ill Patients
- ClinicalTrials.gov ID
- NCT01923480
- Acronym / sponsor ID
- CT-12-0012
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Baxter Healthcare CorporationIndustry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 15 Aug 2013 (estimated)
- Results
- Posted 27 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the best rate of infusion of amino acids (15% CLINISOL - sulfite-free (Amino Acid) Injection) for nutrition in subjects with with stages II to IVB head and neck cancer.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 15% CLINISOL 0.04 g/kg/hr | Experimental | Drug: 15% CLINISOL - Sulfite-free (Amino Acid) Injection15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection. |
| 15% CLINISOL 0.08 g/kg/hr | Experimental | Drug: 15% CLINISOL - Sulfite-free (Amino Acid) Injection15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection. |
| 15% CLINISOL 0.13 g/kg/hr | Experimental | Drug: 15% CLINISOL - Sulfite-free (Amino Acid) Injection15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Have Stages II to IVB head and neck cancer receiving radiation and may also be receiving chemotherapy.
- Have voluntarily signed and dated a written informed consent form (ICF) after the nature of the study was explained to them.
- Female subjects must be of non childbearing potential (defined as postmenopausal for at least 1 year or surgically sterile [bilateral tubal ligation, bilateral oophorectomy or hysterectomy]) or;
- Female subjects of childbearing potential must be using adequate contraception (practicing 1 of the following methods of birth control):
- Female subjects must have a negative serum or urinary pregnancy test result at screening (serum specimen must be obtained within 14 days prior to baseline).
Key exclusion criteria (8 listed)
- Had a loss of > 10% of body weight within the 3 month period prior to the study as noted in the subjects medical history chart.
- Have renal disease as determined by an estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m2.
- Have a hemoglobin level of < 9 g/dl.
- Have Stage 0, I, or IVC metastatic cancer.
- Have diabetes.
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 |
|---|---|---|
| 15% CLINISOL - Sulfite-free (Amino Acid) Injection | Drug | 15% CLINISOL 0.04 g/kg/hr |
| 15% CLINISOL - Sulfite-free (Amino Acid) Injection | Drug | 15% CLINISOL 0.08 g/kg/hr |
| 15% CLINISOL - Sulfite-free (Amino Acid) Injection | Drug | 15% CLINISOL 0.13 g/kg/hr |
Primary outcome
Change in Net Protein Synthesis
Time frame: One time at pre-clinisol infusion and one time at post-clinisol infusion
24 secondary outcomes
Insulin Sensitivity
Time frame: Five times during each 7 hour visit
Plasma Concentration of Glucose
Time frame: Nine times during each 7 hour visit
Serum Concentration of Insulin
Time frame: Five times during each 7 hour visit
Plasma Stable Isotope Enrichment of Phenylalanine
Time frame: Twelve times during each 7 hour visit
Plasma Stable Isotope Enrichment of Tyrosine
Time frame: Twelve times during each 7 hour visit
Plasma Concentration of Alanine
Time frame: Three times during each 7 hour visit
Plasma Concentration of Arginine
Time frame: Three times during each 7 hour visit
Plasma Concentration of Aspartic Acid
Time frame: Three times during each 7 hour visit
Plasma Concentration of Glutamic Acid
Time frame: Three times during each 7 hour visit
Plasma Concentration of Glutamine
Time frame: Three times during each 7 hour visit
Plasma Concentration of Glycine
Time frame: Three times during each 7 hour visit
Plasma Concentration of Histidine
Time frame: Three times during each 7 hour visit
Plasma Concentration of Isoleucine
Time frame: Three times during each 7 hour visit
Plasma Concentration of Leucine
Time frame: Three times during each 7 hour visit
Plasma Concentration of Lysine
Time frame: Three times during each 7 hour visit
Plasma Concentration of Methionine
Time frame: Three times during each 7 hour visit
Plasma Concentration of Ornithine
Time frame: Three times during each 7 hour visit
Plasma Concentration of Phenylalanine
Time frame: Three times during each 7 hour visit
Plasma Concentration of Proline
Time frame: Three times during each 7 hour visit
Plasma Concentration of Serine
Time frame: Three times during each 7 hour visit
Plasma Concentration of Taurine
Time frame: Three times during each 7 hour visit
Plasma Concentration of Threonine
Time frame: Three times during each 7 hour visit
Plasma Concentration of Tyrosine
Time frame: Three times during each 7 hour visit
Plasma Concentration of Valine
Time frame: Three times during each 7 hour visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 15% CLINISOL - Sulfite-free (Amino Acid) Injection in people with Parenteral Nutrition (No Primary Condition Studied), run by Baxter Healthcare Corporation at 2 sites 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 11 inclusion and 8 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 27 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 27 Mar 2017). 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 in Net Protein Synthesis (time frame: One time at pre-clinisol infusion and one time at post-clinisol infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Mar 2017.