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

NCT03773003 | Recruiting

• 1 other identifier: IMPROFA
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer Related Fatigue; Fatigue Syndrome, Chronic

Keywords

Cancer Fatigue, Chronic Fatigue

Outcome Measures

Primary Outcomes (1)

• Improvement of fatigue symptoms

  Improvement of fatigue as measured by validated psychometric questionnaires.

  3 months after end of chemotherapy

Study Arms (4)

Arm 1: Tumor disease w/o fatigue

ACTIVE COMPARATOR

Group receiving probiotics.

Dietary Supplement: Probiotics

Arm 2: Tumor disease w/o fatigue

PLACEBO COMPARATOR

Group receiving placebo (corn starch)

Dietary Supplement: Placebo

Arm 3: Healthy control group

ACTIVE COMPARATOR

Group receiving probiotics

Dietary Supplement: Probiotics

Arm 4: Healthy control group

PLACEBO COMPARATOR

Group receiving placebo (corn starch)

Dietary Supplement: Placebo

Interventions

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

Arm 1: Tumor disease w/o fatigue; Arm 3: Healthy control group

Placebo DIETARY_SUPPLEMENT

Identically looking to verum, containing corn starch.

Arm 2: Tumor disease w/o fatigue; Arm 4: Healthy control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• chronic-inflammatory bowel disease
• pregnancy

Sponsors & Collaborators

• Universität des Saarlandes: lead

Study Sites (1)

Saarland University Medical Center

Homburg, Saarland, 66424, Germany

RECRUITING

MeSH Terms

Conditions

Fatigue Syndrome, Chronic

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Michael Jelden, MD

  University Hospital, Saarland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Jelden, MD

CONTACT

+4968411630000; michael.jelden@uks.eu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Double blinded, placebo controlled intervention with probiotics There are three groups in the study: 1. Tumor disease with fatigue 2. Tumor disease without fatigue 3. Healthy control group

Study Record Dates

• First Submitted: December 10, 2018
• First Posted: December 12, 2018
• Study Start: July 20, 2021
• Primary Completion: July 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 29, 2025

Record last verified: 2025-05

Locations

DE (1)