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

Sponsor

University Hospital, Saarland (Other)

Overall Status

Recruiting

CT.gov ID

NCT03773003

Collaborator

(none)

150

Enrollment

Location

Arms

16.4

Anticipated Duration (Months)

9.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer Related Fatigue Fatigue Syndrome, Chronic	Dietary Supplement: Probiotics Dietary Supplement: Placebo	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Double blinded, placebo controlled intervention with probiotics There are three groups in the study: Tumor disease with fatigue Tumor disease without fatigue Healthy control groupDouble blinded, placebo controlled intervention with probioticsThere are three groups in the study:Tumor disease with fatigue Tumor disease without fatigue Healthy control group

Masking:

Single (Investigator)

Masking Description:

Blinding will be made at the probiotics manufacturer's establishment. Neither investigators nor care providers nor patients know their status til the end of the study.

Primary Purpose:

Basic Science

Official 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

Actual Study Start Date :

Jul 20, 2021

Anticipated Primary Completion Date :

Nov 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

Improvement of fatigue symptoms [3 months after end of chemotherapy]
Improvement of fatigue as measured by validated psychometric questionnaires.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

chronic-inflammatory bowel disease
pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Saarland University Medical Center	Homburg	Saarland	Germany	66424

Sponsors and Collaborators

University Hospital, Saarland

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Michael Jelden, Principal Investigator, University Hospital, Saarland

ClinicalTrials.gov Identifier:

NCT03773003

Other Study ID Numbers:

IMPROFA

First Posted:

Dec 12, 2018

Last Update Posted:

Sep 29, 2021

Last Verified:

Sep 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Michael Jelden, Principal Investigator, University Hospital, Saarland

Cancer Fatigue, Chronic Fatigue

Additional relevant MeSH terms:

Fatigue Syndrome, Chronic

Fatigue

Study Results

No Results Posted as of Sep 29, 2021