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Cancer Cachexia: Organ-specific Protein Synthesis 2

Cancer Cachexia: Organ-specific Protein Synthesis 2 - CCOPS2

Status
Unknown
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON43238
Enrollment
33
Registered
2016-08-10
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer cachexia pancreatic cancer

Interventions

None listed

Sponsors

Universiteit Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Cachectic patients with pancreatic cancer (n=11) - Age >= 18 - Planned pancreaticoduodenectomy for suspected adenocarcinoma of the pancreas head (histological evidence not necessary) - Weight loss > 5% in the last six months or BMI 2% or sarcopenia (L3-skeletal muscle index of 2% - Treated with pancreatic enzyme replacement therapy;Non-cachectic patients with pancreatic cancer (n=11) - Age >= 18 - Planned pancreaticoduodenectomy for suspected adenocarcinoma of the pancreas head (histological evidence not necessary) - Weight loss = 20 and weight loss =55 cm2/m2 for men or >=39 cm2/m2 for women) and weight loss = 18 -No history of cancer -Weight loss

Exclusion criteria

Exclusion criteria: -Active acute pancreatitis -Chronic pancreatitis -Previous pancreatic surgery -Inflammatory bowel disease (e.g. Crohn*s disease) -Use of systemic steroids in the past four weeks -Use of anti-inflammatory biological (e.g. TNF-a blockers) in the past four weeks -Abdominal surgery in the past four weeks -Insulin dependent diabetes mellitus -Chronic obstructive pulmonary disease GOLD III and IV -Hearth failure -Total parenteral nutrition at day of surgery -Wheelchair bound -Pregnancy -Neoadjuvant chemotherapy or radiotherapy

Design outcomes

Primary

MeasureTime frame
The primary outcome parameter in this study is tumour and pancreas specific protein synthesis, expressed as fractional synthetic rate (FSR) [%/day]. This parameter is calculated from: • Plasma and tissue free alanine concentration • Plasma enrichment of alanine • Tissue protein bound enrichment of alanine • Alanine enrichment of the tissue free amino acid pool The FSR can be calculated using the following formula: FSR = ((tissue enrichment biopsy - calculated baseline tissue enrichment)/(saliva enrichment*time of study))*100%. Baseline plasma albumin enrichment will be used to calculate baseline tissue enrichment

Secondary

MeasureTime frame
Tissues/protein-specific FSR will be calculated from: o Albumin o Leukocytes o Vastus lateralis muscle o Rectus abdominis muscle o Liver o Gallbladder o Small intestine o Subcutaneous fat o Visceral fat Plasma protein FSR using an unbiased quadrupole time-of-flight mass spectrometry approach. Regional tumour protein incorporation will be assessed using matrix assisted laser desorption/ionisation mass spectrometry imaging.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)