Research for Pathophysiology of Cancer Related Fatigue (CRF) and Chronic Fatigue (CFS/ME) (IMPROFA)
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Michael Jelden, MD
- Phone Number: +4968411630000
- Email: michael.jelden@uks.eu
Study Locations
-
-
Saarland
-
Homburg, Saarland, Germany, 66424
- Recruiting
- Saarland University Medical Center
-
Contact:
- Michael Jelden, Dr.
- Phone Number: 15000 49684116
- Email: michael.jelden@uks.eu
-
Principal Investigator:
- Michael Jelden, Dr.
-
Contact:
- Michael Jelden, Dr.
- Phone Number: 30000 +49684116
- Email: michael.jelden@uks.eu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- histologically, cytologically or radiologically confirmed tumor disease
- indication for chemotherapy
- Written consent to participation
Exclusion Criteria:
- chronic-inflammatory bowel disease
- pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Arm 1: Tumor disease w/o fatigue
Group receiving probiotics.
|
The administered probiotics are readily available on the market and contain
|
|
Placebo Comparator: Arm 2: Tumor disease w/o fatigue
Group receiving placebo (corn starch)
|
Identically looking to verum, containing corn starch.
|
|
Active Comparator: Arm 3: Healthy control group
Group receiving probiotics
|
The administered probiotics are readily available on the market and contain
|
|
Placebo Comparator: Arm 4: Healthy control group
Group receiving placebo (corn starch)
|
Identically looking to verum, containing corn starch.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Improvement of fatigue symptoms
Time Frame: 3 months after end of chemotherapy
|
Improvement of fatigue as measured by validated psychometric questionnaires.
|
3 months after end of chemotherapy
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michael Jelden, MD, University Hospital, Saarland
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IMPROFA
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.