Analysis of cachexia-associated parameters in patients with metastatic disease pancreatobiliary carcinomas with and without exercise therapy

Analysis of cachexia-associated parameters in patients with metastatic disease pancreatobiliary carcinomas with and without exercise therapy - P-Move

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00021179

Enrollment

Registered

2020-05-15

Start date

2020-06-24

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

C22 C24 C25 C23

Interventions

Group 1: The intervention group completes: 3 training units per week over 8 weeks 1x supervised strength training (50-70% of the 1-RM) 2x independently according to an individualized home-based traini

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Histologically proven ductal adenocarcinoma of the pancreas (PDAC) or Biliary System (CCC) Metastatic Disease (Stage IV) ECOG = 2, Starting a new chemotherapy line (= 1st line), Age = 18 years, Fearon Cachexia (20), Written consent, Fluent German

Exclusion criteria

Exclusion criteria: Serious cardiopulmonary disease (EF <45%, NYHA III-IV heart failure, respiratory partial or global insufficiency, uncontrolled hypertension) CNS metastases, Life expectancy <3 months

Design outcomes

Primary

Measure	Time frame
Feasibility analysis: Recruitment rate Number and cause of dropouts (drop-out) Adverse events Compliance of the movement units (min. 75%)	—

Secondary

Measure	Time frame
- Body composition via BIA Body cell mass, lean body mass, fat mass. Phase angle, body weigh, BMI Baseline measurment after enrollment, post-measurement after 8 weeks - Muscle strength HandGrip dynamometer (JAMAR) Timed Up and Go Test (TUG) 1RM test of large muscle groups Sit-to-Stand test, 1min Baseline measurment after enrollment, measurement after 4 weeks, post-measurement after 8 weeks - Karnovsky index / ECOG Weekly measurement after enrollment - Blood panel: Diff. Blood count / neutrophil-lymphocyte ratio (NLR), electrolytes, kidney values, liver values, LDH, CK, CK-MB, CRP, HbA1c, cholesterol, HDL, LDL, triglycerides, IL6, glucose, lactate, BNP, albumin, CA19-9 , Testosterone (men only), TSH, fT3, fT4 Baseline measurment after enrollment, every two weeks measurement until end of studies - Tumor tissue diagnosis: Grading WTZ NGS cancer gene panel "MAPK1" Transcriptome analysis (Illumina HT12 microarray-based) MCT1, MCT4, LC3, beclin-1 (immunohistochemistry) Baseline measurment after enrollment, post-measurement after 8 weeks - Questionnaires Quality of life (EORTC QLQ-C30) Fatigue (MFI 20) Physical Activity (BSA) Depression & Anxiety (HADS) Cachexia (FAACT) Baseline measurment after enrollment, post-measurement after 8 weeks	—

Measure

Time frame

- Body composition via BIA Body cell mass, lean body mass, fat mass. Phase angle, body weigh, BMI Baseline measurment after enrollment, post-measurement after 8 weeks - Muscle strength HandGrip dynamometer (JAMAR) Timed Up and Go Test (TUG) 1RM test of large muscle groups Sit-to-Stand test, 1min Baseline measurment after enrollment, measurement after 4 weeks, post-measurement after 8 weeks - Karnovsky index / ECOG Weekly measurement after enrollment - Blood panel: Diff. Blood count / neutrophil-lymphocyte ratio (NLR), electrolytes, kidney values, liver values, LDH, CK, CK-MB, CRP, HbA1c, cholesterol, HDL, LDL, triglycerides, IL6, glucose, lactate, BNP, albumin, CA19-9 , Testosterone (men only), TSH, fT3, fT4 Baseline measurment after enrollment, every two weeks measurement until end of studies - Tumor tissue diagnosis: Grading WTZ NGS cancer gene panel "MAPK1" Transcriptome analysis (Illumina HT12 microarray-based) MCT1, MCT4, LC3, beclin-1 (immunohistochemistry) Baseline measurment after enrollment, post-measurement after 8 weeks - Questionnaires Quality of life (EORTC QLQ-C30) Fatigue (MFI 20) Physical Activity (BSA) Depression & Anxiety (HADS) Cachexia (FAACT) Baseline measurment after enrollment, post-measurement after 8 weeks

—

Countries

Germany

Contacts

Public ContactJens Siveke

Universitätsklinikum Essen, Westdeutsches Tumorzentrum, Innere Klinik (Tumorforschung)

Jens.Siveke@uk-essen.de0201-723-3312

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 6, 2026