Trial record 20 of 252 for:    Open Studies | "Body Weight Changes"

Non-Invasive Assessment of Skeletal Muscle Loss in Cancer Patients - Phase II (3MH-2)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by The University of Texas, Galveston
Sponsor:
Information provided by (Responsible Party):
The University of Texas, Galveston
ClinicalTrials.gov Identifier:
NCT01694602
First received: September 24, 2012
Last updated: January 31, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Cachexia
Biological: (non-radioactive) Oral deuterated 3-methylhistidine (D-3MH)
Phase 2

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Non-Invasive Assessment of Skeletal Muscle Loss in Cancer Patients - Phase 2

Resource links provided by NLM:


Further study details as provided by The University of Texas, Galveston:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Spot urine samples.


Estimated Enrollment: 30
Study Start Date: November 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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).
Biological: (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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.

Criteria

Inclusion Criteria:

  • (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.

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01694602

Contacts
Contact: Kathleen M. Randolph, B.S. 409 772 8126 kmrandol@utmb.edu
Contact: William J. Durham, PhD 409 772 8702 wjdurham@utmb.edu

Locations
United States, Texas
University of Texas Medical Branch Recruiting
Galveston, Texas, United States, 77555-0361
Sponsors and Collaborators
The University of Texas, Galveston
Investigators
Principal Investigator: William J Durham, PhD The University of Texas Medical Branch (UTMB Health), Galveston, Texas.
  More Information

No publications provided

Responsible Party: The University of Texas, Galveston
ClinicalTrials.gov Identifier: NCT01694602     History of Changes
Other Study ID Numbers: 12-064, 2R44AR054993-02
Study First Received: September 24, 2012
Last Updated: January 31, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by The University of Texas, Galveston:
Cachexia
Sarcopenia
De Novo
Deuterated

Additional relevant MeSH terms:
Cachexia
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 20, 2014