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

Study 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.

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

Conditions
-----------------
Cancer Related Fatigue, Fatigue Syndrome, Chronic

Intervention / Treatment
-----------------
* Dietary Supplement: Probiotics
* Dietary Supplement: Placebo


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double blinded, placebo controlled intervention with probiotics There are three groups in the study: Tumor disease with fatigue Tumor disease without fatigue Healthy control group
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1: Tumor disease w/o fatigue<br>Group receiving probiotics. | Dietary Supplement: Probiotics<br>* 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<br>|
| Placebo Comparator: Arm 2: Tumor disease w/o fatigue<br>Group receiving placebo (corn starch) | Dietary Supplement: Placebo<br>* Identically looking to verum, containing corn starch.<br>|
| Active Comparator: Arm 3: Healthy control group<br>Group receiving probiotics | Dietary Supplement: Probiotics<br>* 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<br>|
| Placebo Comparator: Arm 4: Healthy control group<br>Group receiving placebo (corn starch) | Dietary Supplement: Placebo<br>* Identically looking to verum, containing corn starch.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of fatigue symptoms | Improvement of fatigue as measured by validated psychometric questionnaires. | 3 months after end of chemotherapy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cancer Fatigue, Chronic Fatigue