Research on the causes of fatigue in cancer and chronic fatigue syndrome
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
This study is testing the causes of fatigue in cancer patients and those with chronic fatigue syndrome, while also seeing if probiotics can help reduce their tiredness.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Universität des Saarlandes Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Homburg, Saarland) |
| Trial ID | NCT03773003 on ClinicalTrials.gov |
What this trial studies
This study investigates the underlying causes of Cancer Related Fatigue (CRF) and Chronic Fatigue Syndrome (CFS/ME) by analyzing lipidomics, metabolomics, microbiomes, and exomes in patients with tumor diseases. Participants will be compared to age- and gender-matched control groups to identify differences in these biological markers. Additionally, the study will explore the potential benefits of probiotics in alleviating fatigue symptoms through a double-blinded, placebo-controlled approach. The research aims to provide insights into the pathophysiology of these conditions and evaluate the effectiveness of probiotics.
Who should consider this trial
Good fit: Ideal candidates include patients with confirmed tumor diseases who are indicated for chemotherapy and willing to provide written consent.
Not a fit: Patients with chronic-inflammatory bowel disease or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and treatment options for patients suffering from cancer-related fatigue and chronic fatigue syndrome.
How similar studies have performed: Other studies have explored similar approaches to understanding fatigue syndromes, but this specific combination of methodologies is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * histologically, cytologically or radiologically confirmed tumor disease * indication for chemotherapy * Written consent to participation Exclusion Criteria: * chronic-inflammatory bowel disease * pregnancy
Where this trial is running
Homburg, Saarland
- Saarland University Medical Center — Homburg, Saarland, Germany (Recruiting)
Study contacts
- Principal investigator: Michael Jelden, MD — University Hospital, Saarland
- Study coordinator: Michael Jelden, MD
- Email: michael.jelden@uks.eu
- Phone: +4968411630000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.