Clinical trial • Phase IV • Oncology

VALINE, ALANINE, ARGININE, HISTIDINE, ISOLEUCINE, LEUCINE, METHIONINE, PHENYLALANINE, PROLINE, SERINE, TAURINE, THREONINE, TYROSINE, GLYCINE, OLIVE OIL, REFINED, SOYA-BEAN OIL REFINED, TRIGLYCERIDES, MEDIUM CHAIN, TRYPTOPHAN, POTASSIUM CHLORIDE, CALCIUM CHLORIDE DIHYDRATE, GLUCOSE MONOHYDRATE, MAGNESIUM SULFATE HEPTAHYDRATE, SODIUM ACETATE TRIHYDRATE, SODIUM GLYCEROPHOSPHATE, LYSINE ACETATE, ZINC SULPHATE HEPTAHYDRATE, FISH OIL, RICH IN OMEGA-3-ACIDS for Oesophagectomy

Phase IV trial of VALINE, ALANINE, ARGININE, HISTIDINE, ISOLEUCINE, LEUCINE, METHIONINE, PHENYLALANINE, PROLINE, SERINE, TAURINE, THREONINE, TYROSINE, GLY…

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Oesophagectomy
Trial Stage
Phase IV
Drug Modality
Other

Key dates

Initial CTIS Submission Date
02-10-2023
First CTIS Authorization Date
16-01-2024

Trial design

Randomised, enteral nutrition (enteral feeding) versus parenteral nutrition with smofkabiven emulsion for infusion (max treatment period 10 days; max daily dose amount reported as 9, units not specified).-controlled Phase IV trial across 1 site in Denmark.

Randomised
Yes
Comparator
Enteral nutrition (enteral feeding) versus parenteral nutrition with SmofKabiven emulsion for infusion (max treatment period 10 days; max daily dose amount reported as 9, units not specified).
Target Sample Size
38
Trial Duration For Participant
10

Eligibility

Recruits 38 No vulnerable populations selected; participants are adults (Age ≥ 18 years). Informed consent is required (Lack of consent is an exclusion). No assent procedures or specific vulnerable-population consent arrangements described..

Pregnancy Exclusion
Women of childbearing age without negative pregnancy test
Vulnerable Population
No vulnerable populations selected; participants are adults (Age ≥ 18 years). Informed consent is required (Lack of consent is an exclusion). No assent procedures or specific vulnerable-population consent arrangements described.

Inclusion criteria

  • {"criterion_text":"- Scheduled for elective oesophagectomy at the Department of Thoracic Surgery, Aarhus University Hospital."}
  • {"criterion_text":"- Included procedures: Oesophagectomy (scopic procedure) with gastric pull-up."}
  • {"criterion_text":"- Distal oesophagectomy with total gastrectomy and other reconstructive procedures (duodenum or colon)"}
  • {"criterion_text":"- Total oesophagectomy with colon anastomosis in the neck area."}
  • {"criterion_text":"- Eligible for both enteral and TPN."}
  • {"criterion_text":"- Age ≥ 18 years"}

Exclusion criteria

  • {"criterion_text":"- Lack of consent"}
  • {"criterion_text":"- Women of childbearing age without negative pregnancy test"}
  • {"criterion_text":"- Known allergy or intolerance to any of the included drugs"}
  • {"criterion_text":"- Diagnosed with primary skeletal muscle disease that could influence muscle wasting according to the investigator"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Mean difference in muscle size assessed by CT-scan from before to 10 days after oesophagostomy","definition_or_measurement_approach":"Muscle size assessed by CT-scan comparing preoperative baseline to 10 days post-oesophagostomy"}

Recruitment

Planned Sample Size
38
Recruitment Window Months
24
Consent Approach
Informed consent is required; lack of consent is listed as an exclusion. Participants are adults (≥18 years). No further details on assent, age-specific consent documents, or languages provided.

Geography

Total Number Of Sites
1
Total Number Of Participants
38

Denmark

Earliest CTIS Part Ii Submission Date
11-12-2023
Latest Decision Or Authorization Date
29-02-2024
Processing Time Days
80
Number Of Sites
1
Number Of Participants
38

Sites

Site Name
Aarhus Universitet
Department Name
Cardio thoracic surgery
Contact Person Name
Frank de Paoli
Contact Person Email
fdp@biomed.au.dk
Number Of Participants
38

Sponsor

Primary sponsor

Full Name
Aarhus Universitet
Organisation Type
Educational Institution
Country Of Registered Address
Denmark

Third parties

  • {"country":"Denmark","full_name":"Aarhus Universitet","duties_or_roles":"sponsorDuties codes 1 and 8","organisation_type":"Educational Institution"}

Investigational products

Investigational Product Name
SmofKabiven emulsion for infusion
Active Substance
VALINE, ALANINE, ARGININE, HISTIDINE, ISOLEUCINE, LEUCINE, METHIONINE, PHENYLALANINE, PROLINE, SERINE, TAURINE, THREONINE, TYROSINE, GLYCINE, OLIVE OIL, REFINED, SOYA-BEAN OIL REFINED, TRIGLYCERIDES, MEDIUM CHAIN, TRYPTOPHAN, POTASSIUM CHLORIDE, CALCIUM CHLORIDE DIHYDRATE, GLUCOSE MONOHYDRATE, MAGNESIUM SULFATE HEPTAHYDRATE, SODIUM ACETATE TRIHYDRATE, SODIUM GLYCEROPHOSPHATE, LYSINE ACETATE, ZINC SULPHATE HEPTAHYDRATE, FISH OIL, RICH IN OMEGA-3-ACIDS
Modality
Other
Routes Of Administration
Parenteral use
Route
Parenteral
Authorisation Status
Authorised (marketingAuthNumber: PL 08828/0187)
Maximum Dose
9 (units not specified)

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