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NCT03773003 Clinical Trial

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

Fatigue Syndrome, Chronic Clinical Trial

— IMPROFA  

Official title:
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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03773003
Other study ID # IMPROFA
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 20, 2021
Est. completion date December 1, 2024

Study information
Verified date April 2023
Source Universität des Saarlandes
Contact Michael Jelden, MD
Phone +4968411630000
Email michael.jelden@uks.eu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 150
Est. completion date December 1, 2024
Est. primary completion date November 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - histologically, cytologically or radiologically confirmed tumor disease - indication for chemotherapy - Written consent to participation Exclusion Criteria: - chronic-inflammatory bowel disease - pregnancy

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• 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.

Locations
Country Name City State
Germany Saarland University Medical Center Homburg Saarland

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Saarland

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Improvement of fatigue symptoms Improvement of fatigue as measured by validated psychometric questionnaires. 3 months after end of chemotherapy
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