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

Universität des Saarlandes

Status: Enrolling

Conditions: Cancer Related Fatigue; Fatigue Syndrome, Chronic

Treatments: Dietary Supplement: Probiotics; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03773003

IMPROFA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• chronic-inflammatory bowel disease
• pregnancy

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 4 patient groups, including a placebo group

Arm 1: Tumor disease w/o fatigue

Active Comparator group

Description:

Group receiving probiotics.

Treatment:

Dietary Supplement: Probiotics

Arm 2: Tumor disease w/o fatigue

Placebo Comparator group

Description:

Group receiving placebo (corn starch)

Treatment:

Dietary Supplement: Placebo

Arm 3: Healthy control group

Active Comparator group

Description:

Group receiving probiotics

Treatment:

Dietary Supplement: Probiotics

Arm 4: Healthy control group

Placebo Comparator group

Description:

Group receiving placebo (corn starch)

Treatment:

Dietary Supplement: Placebo