Cancer Cachexia: Organ-specific Protein Synthesis

Cancer Cachexia: Organ-specific Protein Synthesis - CCOPS

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON41334

Enrollment

Registered

2014-05-26

Start date

2014-09-29

Completion date

Unknown

Last updated

2024-04-29

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

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - 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% - Placement of epidural catheter before surgery

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 - Phenylketonuria (PKU) - Insulin dependent diabetes mellitus - Chronic obstructive pulmonary disease GOLD III and IV - Hearth failure - Total parenteral nutrition at day of surgery - Pregnancy - Neoadjuvant chemotherapy or radiotherapy

Design outcomes

Primary

Measure	Time frame
The primary outcome parameter in this study is tissue specific protein synthesis, expressed as fractional synthetic rate (FSR) [%/h] and the difference in FSR among different types of tissue. This parameter is calculated from: - Plasma and tissue free phenylalanine concentration - Plasma enrichment of L-[U-13C6]-phenylalanine - Tissue protein bound enrichment of L-[U-13C6]-phenylalanine - L-[U-13C6-phenylalanine enrichment of the tissue free amino acid pool De tissues for which the FSR will be calculated are: - Albumine - Leukocytes - Skeletal muscle - Liver - Small intestine - Gallbladder - Pancreas - Pancreatic tumour - Subcutaneous fat - Visceral fat	—

Measure

Time frame

The primary outcome parameter in this study is tissue specific protein synthesis, expressed as fractional synthetic rate (FSR) [%/h] and the difference in FSR among different types of tissue. This parameter is calculated from: - Plasma and tissue free phenylalanine concentration - Plasma enrichment of L-[U-13C6]-phenylalanine - Tissue protein bound enrichment of L-[U-13C6]-phenylalanine - L-[U-13C6-phenylalanine enrichment of the tissue free amino acid pool De tissues for which the FSR will be calculated are: - Albumine - Leukocytes - Skeletal muscle - Liver - Small intestine - Gallbladder - Pancreas - Pancreatic tumour - Subcutaneous fat - Visceral fat

—

Secondary

Measure	Time frame
- Exogenous phenylalanine rate of appearance and plasma availability of phenylalanine - Total phenylalanine rate of appearance and plasma availability of phenylalanine (= whole body protein turnover) - Endogenous tyrosine rate of appearance (= protein breakdown)	—

Countries

Netherlands

Outcome results