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

Last updated: May 22, 2025
Sponsor: Universität des Saarlandes
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pain (Pediatric)

Treatment

Placebo

Probiotics

Clinical Study ID

NCT03773003
IMPROFA
  • Ages 18-80
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

Research for Pathophysiology of Cancer Related Fatigue (CRF) and Chronic Fatigue Syndrome (CFS/ME) by Lipidomics, Metabolomics, Intestinal and Peritoneal Microbiome Analysis and Exome Analysis and Investigation of a Possible Benefit of Probiotics.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • histologically, cytologically or radiologically confirmed tumor disease

  • indication for chemotherapy

  • Written consent to participation

Exclusion

Exclusion Criteria:

  • chronic-inflammatory bowel disease

  • pregnancy

Study Design

Total Participants: 150
Treatment Group(s): 2
Primary Treatment: Placebo
Phase:
Study Start date:
July 20, 2021
Estimated Completion Date:
December 01, 2025

Study 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.

Connect with a study center

  • Saarland University Medical Center

    Homburg, Saarland 66424
    Germany

    Active - Recruiting

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