Cachexia3MH-2NCT01694602
Non-Invasive Assessment of Skeletal Muscle Loss in Cancer Patients - Phase II
An observational study of Cachexia, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
The overall aim of this research is to develop a non-invasive approach to evaluate the production of 3-methylhistidine (3MH)in cancer patients, as a potential means of determining which patients are at high risk for future development of cancer induced skeletal muscle atrophy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cachexia
- What is being tested?
- (non-radioactive) Oral deuterated 3-methylhistidine (D-3MH)
- Type of treatment
- Pill or oral medicine
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Jun 2015
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We will conduct a longitudinal study (repeated measures design) in 30 newly diagnosed nonsmall cell lung cancer (NSCLC) patients who are not candidates for curative resection.
Who may be able to join
- (1) histological or cytological evidence of NSCLC without curative options;
- (2) over 18 years of age;
- (3) patient reported weight loss of ≤5% of usual body weight in the last 6 months;
- (4) life expectancy of greater than 6 months based on the judgement of treating physician;
- (5) serum creatinine ≤1.5 times the upper limit of normal; and
- (6) willing and able to give informed consent.
Who cannot join
- 1) malabsorption, intractable vomiting or gastrointestinal obstruction
- 2) congestive heart failure
- 3) edema or ascites
- 4) liver function test results that will preclude administration of prescribed therapy
- 5) pregnant, nursing, or, if of child-bearing age, unwilling to use contraceptives
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Medical Branch
Galveston, Texas, 77555-0361
About this study
Official title: Non-Invasive Assessment of Skeletal Muscle Loss in Cancer Patients - Phase 2
The overall aim of this research is to develop a non-invasive approach to evaluate the production of 3-methylhistidine (3MH)in cancer patients, as a potential means of determining which patients are at high risk for future development of cancer induced skeletal muscle atrophy.
Rationale: The approach is based on the hypothesis that after an oral dose of deuterated 3-methylhistidine (D-3MH), the slope of the terminal portion of the decay curve (> 12 hours post-dosing) for the tracer/tracee (D-3MH/3MH) in the free 3MH pool is proportional to the rate constant for myofibrillar protein degradation and can be determined from spot urine samples.
Read the detailed description
The long-term objective of this research is to develop a non-invasive approach for assessment of de novo 3MH production in cancer patients early in the course of the disease as a way of assessing which patients are at high risk for future development of skeletal muscle atrophy. The approach is based on: 1) the known increase in de novo production of 3-methylhistidine (3MH) from muscle protein breakdown in said patients as a consequence of their unique disease-host interactions, and 2) earlier demonstration that de novo 3MH production can be measured in vivo using isotope dilution.
During this Phase-II project, we propose to conduct a statistically powerful prospective investigation to demonstrate that measurement of the slope of the terminal decay curve (rate constant) with our approach in newly diagnosed cancer patients predicts future development of muscle wasting. We expect the outcome of the combined Phase-I and Phase-II research to lead to the early identification of elevated muscle catabolism in at-risk patients so that medical intervention can prevent future muscle atrophy.
- Conditions
- Cachexia
- Being tested
- (non-radioactive) Oral deuterated 3-methylhistidine (D-3MH)
- Keywords
- Cachexia, Sarcopenia, De Novo, Deuterated
- Medical subject headings
- Cachexia, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(non-radioactive) Oral deuterated 3-methylhistidine (D-3MH)Biological
Oral dose of 9.0 mg (50 μmol) TAU-METHYL-L-HISTIDINE (METHYL-D3), Cambridge Isotope Laboratory, Cambridge, Massachusetts.
| Study group | Role | What they receive |
|---|---|---|
| Newly Diagnosed NSCLC patients | In this study, newly diagnosed NSCLC patients who are not candidates for curative resection, will receive a (non-radioactive) oral dose of deuterated 3-methylhistidine (D-3MH). Receives: Biological: (non-radioactive) Oral deuterated 3-methylhistidine (D-3MH) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of myofibrillar protein degradation rate constant and slope of terminal decay curve.
Measured: Spot urine (multiple) collections between 12 to 17 hours of D-3MH ingestion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2012 (estimated)
- Study startNov 2012
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CachexiaStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William J Durham, PhD, Principal investigator, The University of Texas Medical Branch (UTMB Health), Galveston, Texas.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01694602
- Sponsor's protocol ID
- 12-064
- Other IDs
- 2R44AR054993-02
- Acronym
- 3MH-2
- Status last verified
- Jul 2015
- First submitted
- 24 Sep 2012
- Last updated
- 2 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Assessment of Skeletal Muscle Loss in Cancer Patients - Phase 2
- ClinicalTrials.gov ID
- NCT01694602
- Acronym / sponsor ID
- 3MH-2 / 12-064
- Conditions
- Cachexia
- Keywords
- Cachexia, Sarcopenia, De Novo, Deuterated
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 27 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall aim of this research is to develop a non-invasive approach to evaluate the production of 3-methylhistidine (3MH)in cancer patients, as a potential means of determining which patients are at high risk for future development of cancer induced skeletal muscle atrophy.
Rationale: The approach is based on the hypothesis that after an oral dose of deuterated 3-methylhistidine (D-3MH), the slope of the terminal portion of the decay curve (> 12 hours post-dosing) for the tracer/tracee (D-3MH/3MH) in the free 3MH pool is proportional to the rate constant for myofibrillar protein degradation and can be determined from spot urine samples.
Detailed description
The long-term objective of this research is to develop a non-invasive approach for assessment of de novo 3MH production in cancer patients early in the course of the disease as a way of assessing which patients are at high risk for future development of skeletal muscle atrophy. The approach is based on: 1) the known increase in de novo production of 3-methylhistidine (3MH) from muscle protein breakdown in said patients as a consequence of their unique disease-host interactions, and 2) earlier demonstration that de novo 3MH production can be measured in vivo using isotope dilution.
During this Phase-II project, we propose to conduct a statistically powerful prospective investigation to demonstrate that measurement of the slope of the terminal decay curve (rate constant) with our approach in newly diagnosed cancer patients predicts future development of muscle wasting. We expect the outcome of the combined Phase-I and Phase-II research to lead to the early identification of elevated muscle catabolism in at-risk patients so that medical intervention can prevent future muscle atrophy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Newly Diagnosed NSCLC patients | – | Biological: (non-radioactive) Oral deuterated 3-methylhistidine (D-3MH)In this study, newly diagnosed NSCLC patients who are not candidates for curative resection, will receive a (non-radioactive) oral dose of deuterated 3-methylhistidine (D-3MH). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We will conduct a longitudinal study (repeated measures design) in 30 newly diagnosed nonsmall cell lung cancer (NSCLC) patients who are not candidates for curative resection.
Key inclusion criteria (6 listed)
- (1) histological or cytological evidence of NSCLC without curative options;
- (2) over 18 years of age;
- (3) patient reported weight loss of ≤5% of usual body weight in the last 6 months;
- (4) life expectancy of greater than 6 months based on the judgement of treating physician;
- (5) serum creatinine ≤1.5 times the upper limit of normal; and
Key exclusion criteria (5 listed)
- 1) malabsorption, intractable vomiting or gastrointestinal obstruction
- 2) congestive heart failure
- 3) edema or ascites
- 4) liver function test results that will preclude administration of prescribed therapy
- 5) pregnant, nursing, or, if of child-bearing age, unwilling to use contraceptives
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 |
|---|---|---|
| (non-radioactive) Oral deuterated 3-methylhistidine (D-3MH)Oral dose of 9.0 mg (50 μmol) TAU-METHYL-L-HISTIDINE (METHYL-D3), Cambridge Isotope Laboratory, Cambridge, Massachusetts. | Biological | Newly Diagnosed NSCLC patients |
Primary outcome
Determination of myofibrillar protein degradation rate constant and slope of terminal decay curve.
Time frame: Spot urine (multiple) collections between 12 to 17 hours of D-3MH ingestion.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2015.
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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.
William J Durham, PhD principal investigator
The University of Texas Medical Branch (UTMB Health), Galveston, Texas.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cachexia, 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 6 inclusion and 5 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: finished, as of the sponsor's last update on 2 Jul 2015. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Determination of myofibrillar protein degradation rate constant and slope of terminal decay curve. (time frame: Spot urine (multiple) collections between 12 to 17 hours of D-3MH ingestion.). 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 2 Jul 2015.