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Clinical Trials/NCT03773003
NCT03773003
Recruiting
Not Applicable

Pathophysiology of Cancer Related Fatigue (CRF) and Chronic Fatigue (CFS/ME) by Lipidomics, Metabolomics, Microbiome and Exome Analysis and Investigation of Clinical Improvement Under Administration of Probiotics

Universität des Saarlandes1 site in 1 country150 target enrollmentJuly 20, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cancer Related Fatigue
Sponsor
Universität des Saarlandes
Enrollment
150
Locations
1
Primary Endpoint
Improvement of fatigue symptoms
Status
Recruiting
Last Updated
11 months ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
July 20, 2021
End Date
December 1, 2025
Last Updated
11 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Michael Jelden

Principal Investigator

University Hospital, Saarland

Eligibility Criteria

Inclusion Criteria

  • histologically, cytologically or radiologically confirmed tumor disease
  • indication for chemotherapy
  • Written consent to participation

Exclusion Criteria

  • chronic-inflammatory bowel disease
  • pregnancy

Outcomes

Primary Outcomes

Improvement of fatigue symptoms

Time Frame: 3 months after end of chemotherapy

Improvement of fatigue as measured by validated psychometric questionnaires.

Study Sites (1)

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