Non-Invasive Assessment of Skeletal Muscle Loss in Cancer Patients - Phase II

NCT01694602 | Completed

• 2 other identifiers: 12-0642R44AR054993-02
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cachexia

Keywords

Cachexia; Sarcopenia; De Novo; Deuterated

Outcome Measures

Primary Outcomes (1)

• Determination of myofibrillar protein degradation rate constant and slope of terminal decay curve.

  Spot urine (multiple) collections between 12 to 17 hours of D-3MH ingestion.

Study Arms (1)

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)

Interventions

(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.

Newly Diagnosed NSCLC patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• (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.

You may not qualify if:

• \) malabsorption, intractable vomiting or gastrointestinal obstruction
• \) congestive heart failure
• \) edema or ascites
• \) liver function test results that will preclude administration of prescribed therapy
• \) pregnant, nursing, or, if of child-bearing age, unwilling to use contraceptives

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

University of Texas Medical Branch

Galveston, Texas, 77555-0361, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Spot urine samples.

MeSH Terms

Conditions

Cachexia; Sarcopenia

Condition Hierarchy (Ancestors)

Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical

Study Officials

• William J Durham, PhD

  The University of Texas Medical Branch (UTMB Health), Galveston, Texas.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2012
• First Posted: September 27, 2012
• Study Start: November 1, 2012
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: July 2, 2015

Record last verified: 2015-07

Locations

US (1)