Research for Pathophysiology of Cancer Related Fatigue (CRF) and Chronic Fatigue (CFS/ME)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversität des Saarlandes
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
histologically, cytologically or radiologically confirmed tumor disease
indication for chemotherapy
Written consent to participation
Disqualifiers
chronic-inflammatory bowel disease
pregnancy
Trial design
Design model
Parallel
Treatments tested in this trial
Probiotics
Dietary supplementThe 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
Dietary supplementIdentically looking to verum, containing corn starch.
Treatment groups
150 Participants
are divided into 4 treatment groupsGroup A: Arm 1: Tumor disease w/o fatigueActive comparator 1 intervention
Group B: Arm 2: Tumor disease w/o fatiguePlacebo comparator 1 intervention
Group C: Arm 3: Healthy control groupActive comparator 1 intervention
Group D: Arm 4: Healthy control groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Improvement of fatigue symptoms
Improvement of fatigue as measured by validated psychometric questionnaires.
Time frame
3 months after end of chemotherapySponsors and contacts
Click on the lead sponsor to view all of their trials.
Universität des Saarlandes
Lead sponsor
University Hospital, Saarland
Sponsor institution
Source ClinicalTrials.gov