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

Not Applicable

Recruiting

• Conditions: Fatigue Syndrome, Chronic; Cancer Related Fatigue
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Probiotics

• Registration Number: NCT03773003
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2018-12-10
• Study First Submitted QC: 2018-12-11
• Study First Posted: 2018-12-12
• Study Start: 2021-07-20
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-11
• Last Update Posted: 2023-04-12
• Primary Completion: 2024-11-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

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

Exclusion Criteria

• chronic-inflammatory bowel disease
• pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 4: Healthy control group	Placebo	Group receiving placebo (corn starch)
Arm 2: Tumor disease w/o fatigue	Placebo	Group receiving placebo (corn starch)
Arm 1: Tumor disease w/o fatigue	Probiotics	Group receiving probiotics.
Arm 3: Healthy control group	Probiotics	Group receiving probiotics

Primary Outcome Measures

Name	Time	Method
Improvement of fatigue symptoms	3 months after end of chemotherapy	Improvement of fatigue as measured by validated psychometric questionnaires.

Trial Locations

Locations (1)

Saarland University Medical Center; 🇩🇪 Homburg, Saarland, Germany