Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03773003
Recruitment Status : Recruiting
First Posted : December 12, 2018
Last Update Posted : August 26, 2019
Sponsor:
Information provided by (Responsible Party):
Michael Jelden, MD, University Hospital, Saarland

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.

Condition or disease Intervention/treatment Phase
Cancer Related Fatigue Fatigue Syndrome, Chronic Dietary Supplement: Probiotics Dietary Supplement: Placebo Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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
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.
Primary Purpose: Basic Science
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
Actual Study Start Date : August 20, 2019
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Arm 1: Tumor disease w/o fatigue
Group receiving probiotics.
Dietary Supplement: Probiotics

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

Placebo Comparator: Arm 2: Tumor disease w/o fatigue
Group receiving placebo (corn starch)
Dietary Supplement: Placebo
Identically looking to verum, containing corn starch.

Active Comparator: Arm 3: Healthy control group
Group receiving probiotics
Dietary Supplement: Probiotics

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

Placebo Comparator: Arm 4: Healthy control group
Group receiving placebo (corn starch)
Dietary Supplement: Placebo
Identically looking to verum, containing corn starch.




Primary Outcome Measures :
  1. Improvement of fatigue symptoms [ Time Frame: 3 months after end of chemotherapy ]
    Improvement of fatigue as measured by validated psychometric questionnaires.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • histologically, cytologically or radiologically confirmed tumor disease
  • indication for chemotherapy
  • Written consent to participation

Exclusion Criteria:

  • chronic-inflammatory bowel disease
  • pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03773003


Contacts
Layout table for location contacts
Contact: Michael Jelden, MD +4968411630000 michael.jelden@uks.eu

Locations
Layout table for location information
Germany
Saarland University Medical Center Recruiting
Homburg, Saarland, Germany, 66424
Contact: Michael Jelden, Dr.    +49684116 ext 30000    michael.jelden@uks.eu   
Contact: Michael Jelden, Dr.    49684116 ext 15000    michael.jelden@uks.eu   
Principal Investigator: Michael Jelden, Dr.         
Sponsors and Collaborators
University Hospital, Saarland
Investigators
Layout table for investigator information
Principal Investigator: Michael Jelden, MD University Hospital, Saarland

Layout table for additonal information
Responsible Party: Michael Jelden, MD, Principal Investigator, University Hospital, Saarland
ClinicalTrials.gov Identifier: NCT03773003     History of Changes
Other Study ID Numbers: IMPROFA
First Posted: December 12, 2018    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: August 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michael Jelden, MD, University Hospital, Saarland:
Cancer Fatigue, Chronic Fatigue
Additional relevant MeSH terms:
Layout table for MeSH terms
Fatigue Syndrome, Chronic
Fatigue
Signs and Symptoms
Virus Diseases
Muscular Diseases
Musculoskeletal Diseases
Encephalomyelitis
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases