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JOURNAL ONKOLOGIE – STUDIE
IMPROFA

Research for Pathophysiology of Cancer Related Fatigue (CRF) and Chronic Fatigue (CFS/ME)

Rekrutierend

NCT-Nummer:
NCT03773003

Studienbeginn:
Juli 2021

Letztes Update:
12.04.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Fatigue Syndrome, Chronic, Fatigue

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
University Hospital, Saarland

Collaborator:
-

Studienleiter

Michael Jelden, MD
Principal Investigator
University Hospital, Saarland

Kontakt

Studienlocations
(1 von 1)

Saarland University Medical Center
66424 Homburg
(Saarland)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Michael Jelden, Dr.
Phone: +49684116
Phone (ext.): 30000
E-Mail: michael.jelden@uks.eu

Michael Jelden, Dr.
Phone: 49684116
Phone (ext.): 15000
E-Mail: michael.jelden@uks.eu» Ansprechpartner anzeigen

Studien-Informationen

Detailed Description:

This study aims to identify the underlying pathophysiology of Cancer Related Fatigue (CRF) by

screening lipidome, metabolome, exome and microbiome of affected patients with tumor disease

with and without fatigue. These results will be compared to an age- and gender matched

control group with a comparable tumor disease and to another age- and gender matched control

group without tumor disease.

The investigators are following the same strategy for investigating an underlying

pathophysiology of Chronic Fatigue Syndrome (CFS/ME) in another group of patients. The age-

and gender matched control group will be established from the beforementioned control group.

The investigators will also be screening for a peritoneal microbiome (possible correlate for

leaky gut) in study patients undergoing abdominal surgery.

We will also investigate changes in fatigue and in lipidome, metabolome, exome and microbiome

by double-blinded, placebo-controlled administration of probiotics to the study population.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- histologically, cytologically or radiologically confirmed tumor disease

- indication for chemotherapy

- Written consent to participation

Exclusion Criteria:

- chronic-inflammatory bowel disease

- pregnancy

Studien-Rationale

Primary outcome:

1. Improvement of fatigue symptoms (Time Frame - 3 months after end of chemotherapy):
Improvement of fatigue as measured by validated psychometric questionnaires.

Studien-Arme

  • Active Comparator: Arm 1: Tumor disease w/o fatigue
    Group receiving probiotics.
  • Placebo Comparator: Arm 2: Tumor disease w/o fatigue
    Group receiving placebo (corn starch)
  • Active Comparator: Arm 3: Healthy control group
    Group receiving probiotics
  • Placebo Comparator: Arm 4: Healthy control group
    Group receiving placebo (corn starch)

Geprüfte Regime

  • Probiotics:
    The administered probiotics are readily available on the market and contain Bifidobacterium breve, B. infantis, B. lactis, B. longum Lactobacillus acidophilus, L. bulgaricus, L. casei, L. crispatus, L. fermentum, L. paracasei, L. plantarum, L. reuteri, L. rhamnosus, L. salivarius Streptococcus thermophilus
  • Placebo:
    Identically looking to verum, containing corn starch.

Quelle: ClinicalTrials.gov


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