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

May 22, 2025 updated by: Michael Jelden, Universität des Saarlandes

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

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.

Study Overview

Status

Recruiting

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

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
    • Saarland
      • Homburg, Saarland, Germany, 66424
        • Recruiting
        • Saarland University Medical Center
        • Contact:
        • Principal Investigator:
          • Michael Jelden, Dr.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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.

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

This is where you will find people and organizations involved with this study.

Sponsor

Universität des Saarlandes

Investigators

  • Principal Investigator: Michael Jelden, MD, University Hospital, Saarland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 20, 2021

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

December 10, 2018

First Submitted That Met QC Criteria

December 11, 2018

First Posted (Actual)

December 12, 2018

Study Record Updates

Last Update Posted (Actual)

May 29, 2025

Last Update Submitted That Met QC Criteria

May 22, 2025

Last Verified

May 1, 2025

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

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

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