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NCT Number: NCT03773003

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saarland University Medical Center

Homburg, Saarland, 66424, Germany

Location status: Recruiting

Location contact

Michael Jelden, Dr.

CONTACT

[email protected]

+49684116 ext. 30000

Michael Jelden, Dr.

CONTACT

[email protected]

49684116 ext. 15000

Michael Jelden, Dr.

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • chronic-inflammatory bowel disease
  • pregnancy

Treatment and study plan

Probiotics

Dietary Supplement

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

Dietary Supplement

Identically looking to verum, containing corn starch.

Primary outcomes

  1. Improvement of fatigue symptoms

    Time frame: 3 months after end of chemotherapy

    Improvement of fatigue as measured by validated psychometric questionnaires.

Study contacts

Contact information is provided by the study sponsor or research team.

Michael Jelden, MD

CONTACT

[email protected]

+4968411630000

Sponsors and collaborators

Lead sponsor

Universität des Saarlandes

Other

Registry information

Official study 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

Acronym: IMPROFA

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Dec 12, 2018
Registry last updated
May 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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