Actively Recruiting
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
Led by Universität des Saarlandes · Updated on 2025-05-29
150
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the underlying causes of Cancer Related Fatigue (CRF) and Chronic Fatigue Syndrome (CFS/ME) by analyzing blood lipids, metabolites, genetic information, and gut bacteria in patients with and without fatigue. They compare findings from patients with tumor disease both with fatigue and without fatigue, as well as healthy individuals matched by age and gender. The study also explores the possible benefits of probiotics in improving fatigue symptoms. Participants are randomly assigned to receive either probiotics containing various beneficial bacteria strains or a placebo made of corn starch. These probiotics include several types of Bifidobacterium, Lactobacillus, and Streptococcus species. The study groups include patients with tumor disease who have or do not have fatigue, and healthy control groups. The trial is single-blinded and involves administration of the probiotic or placebo. During the study, researchers collect and analyze samples for lipidomics, metabolomics, exome, and microbiome changes. Participants undergoing abdominal surgery may have samples taken from the peritoneal microbiome. Fatigue symptoms are assessed, with the main outcome measure being improvement in fatigue three months after chemotherapy ends. The study includes follow-up assessments to monitor changes and safety, with total participation lasting several months.
CONDITIONS
Brief Title
Research for Pathophysiology of Cancer Related Fatigue (CRF) and Chronic Fatigue (CFS/ME)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically, cytologically or radiologically confirmed tumor disease
- Indication for chemotherapy
- Written consent to participation
You will not qualify if you...
- Chronic-inflammatory bowel disease
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months
Participants receive either probiotics or placebo to investigate changes in fatigue and biological markers.
Regular visits during probiotic or placebo administration period
Duration - 3 months after end of chemotherapy
Participants are monitored for improvement of fatigue symptoms after the end of chemotherapy.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Saarland University Medical Center
Homburg, Saarland, Germany, 66424
Actively Recruiting
Research Team
M
Michael Jelden, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
4
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