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
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.
Investigators
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.