Can oral protein intake of 1.5g/kg bw/day improve nutritional status, serum albumin levels, lean muscle mass and quality of life in patients under adjuvant chemotherapy after Kausch-Whipple surgery for pancreatic head cancer?

Can oral protein intake of 1.5g/kg bw/day improve nutritional status, serum albumin levels, lean muscle mass and quality of life in patients under adjuvant chemotherapy after Kausch-Whipple surgery for pancreatic head cancer? - EWA - nutrition therapy after Whipple surgery followed by adjuvant chemotherapy.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00015744

Enrollment

Registered

2018-10-30

Start date

2016-04-04

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

C25

Interventions

Group 1: At the beginning of the 13-week study, the nutritional status of all participating patients will be determined using the Nutritional Risk Score (NRS 2002), Bioelectrical Impedance Analysis (B

or (b) 1,5g/kg bw/d protein powder (Resource complete HP) - verum group. In addition to the primary endpoint of improving serum albumin levels through the intervention, the secondary endpoint is the

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Inclusion criteria

Inclusion criteria: Consecutive participation in the study is offered to patients of all ages and sex after Kausch-Whipple surgery (pylorus-preserving or with partial gastric resection) for pancreatic head carcinomas. Prerequisites are the patient's ability to consent and a physical condition that permits chemotherapy and the intake of a 200ml protein-rich standard drink.

Exclusion criteria

Exclusion criteria: Exclusion criteria: Patients with metastatic or inoperable pancreatic head tumors.

Design outcomes

Primary

Measure	Time frame
Serum albumin levels, fat-free body mass and quality of life are recorded four times over a period of 13 weeks. The serum albumin level as the primary endpoint is measured by blood collection and laboratory determination. Fat-free muscle mass is determined by Bioelectric Impedance Analysis (BIA) and quality of life is measured using QLQ C30.	—

Countries

Germany

Contacts

Public ContactCordula Seiß

GHD GesundHeitsGmbh Deutschland

c.seiss@gesundheitsgmbh.de+49-(0)1728597432

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026