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

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ClinicalTrials.gov Identifier: NCT03773003
Recruitment Status : Recruiting
First Posted : December 12, 2018
Last Update Posted : August 26, 2019
Sponsor:
Information provided by (Responsible Party):
Michael Jelden, MD, University Hospital, Saarland

Tracking Information
First Submitted Date  ICMJE December 10, 2018
First Posted Date  ICMJE December 12, 2018
Last Update Posted Date August 26, 2019
Actual Study Start Date  ICMJE August 20, 2019
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 28, 2018)
Improvement of fatigue symptoms [ Time Frame: 3 months after end of chemotherapy ]
Improvement of fatigue as measured by validated psychometric questionnaires.
Original Primary Outcome Measures  ICMJE
 (submitted: December 11, 2018)
Improvement of fatigue symptoms [ Time Frame: 3 months after end of chemotherapy ]
Improvement of fatigue as measured by the EORTC QLQ-FA12 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Fatigue) questionnaire, i.e. fewer points on numeric scale.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Research for Pathophysiology of Cancer Related Fatigue (CRF) and Chronic Fatigue (CFS/ME)
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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
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
Condition  ICMJE
  • Cancer Related Fatigue
  • Fatigue Syndrome, Chronic
Intervention  ICMJE
  • 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
  • Dietary Supplement: Placebo
    Identically looking to verum, containing corn starch.
Study Arms  ICMJE
  • Active Comparator: Arm 1: Tumor disease w/o fatigue
    Group receiving probiotics.
    Intervention: Dietary Supplement: Probiotics
  • Placebo Comparator: Arm 2: Tumor disease w/o fatigue
    Group receiving placebo (corn starch)
    Intervention: Dietary Supplement: Placebo
  • Active Comparator: Arm 3: Healthy control group
    Group receiving probiotics
    Intervention: Dietary Supplement: Probiotics
  • Placebo Comparator: Arm 4: Healthy control group
    Group receiving placebo (corn starch)
    Intervention: Dietary Supplement: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 11, 2018)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2021
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • chronic-inflammatory bowel disease
  • pregnancy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Michael Jelden, MD +4968411630000 michael.jelden@uks.eu
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03773003
Other Study ID Numbers  ICMJE IMPROFA
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michael Jelden, MD, University Hospital, Saarland
Study Sponsor  ICMJE University Hospital, Saarland
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael Jelden, MD University Hospital, Saarland
PRS Account University Hospital, Saarland
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP