Cancer Related Fatigue, Fatigue Syndrome, Chronic
Conditions
Keywords
Cancer Fatigue, Chronic Fatigue
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.
Interventions
DIETARY_SUPPLEMENTProbiotics
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
DIETARY_SUPPLEMENTPlacebo
Identically looking to verum, containing corn starch.
Sponsors
Universität des Saarlandes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Investigator)
Masking description
Blinding will be made at the probiotics manufacturer's establishment. Neither investigators nor care providers nor patients know their status til the end of the study.
Intervention model description
Double blinded, placebo controlled intervention with probiotics There are three groups in the study: 1. Tumor disease with fatigue 2. Tumor disease without fatigue 3. Healthy control group
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* histologically, cytologically or radiologically confirmed tumor disease * indication for chemotherapy * Written consent to participation
Exclusion criteria
* chronic-inflammatory bowel disease * pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of fatigue symptoms | 3 months after end of chemotherapy | Improvement of fatigue as measured by validated psychometric questionnaires. |
Countries
Germany
Contacts
Primary ContactMichael Jelden, MD
Outcome results
None listed