Cancer Related FatigueIMPROFANCT03773003
Research for Pathophysiology of Cancer Related Fatigue (CRF) and Chronic Fatigue (CFS/ME)
A study testing Probiotics in people with Cancer Related Fatigue and Fatigue Syndrome, Chronic, run by Universität des Saarlandes at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer Related Fatigue, Fatigue Syndrome, Chronic
- What is being tested?
- Probiotics
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- 20 Jul 2021to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- histologically, cytologically or radiologically confirmed tumor disease
- indication for chemotherapy
- Written consent to participation
Who cannot join
- chronic-inflammatory bowel disease
- pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Saarland University Medical Center
Homburg, Saarland, 66424
Michael Jelden, Dr., +49684116 ext. 30000, michael.jelden@uks.eu
Michael Jelden, Dr., 49684116 ext. 15000, michael.jelden@uks.eu
About this study
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
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.
Read the 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.
- Conditions
- Cancer Related Fatigue, Fatigue Syndrome, Chronic
- Being tested
- Probiotics, Placebo
- Keywords
- Cancer Fatigue, Chronic Fatigue
- Medical subject headings
- Fatigue Syndrome, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticsDietary 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
PlaceboDietary supplement
Identically looking to verum, containing corn starch.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Tumor disease w/o fatigue | Active comparator | Group receiving probiotics. Receives: Dietary Supplement: Probiotics |
| Arm 2: Tumor disease w/o fatigue | Placebo comparator | Group receiving placebo (corn starch) Receives: Dietary Supplement: Placebo |
| Arm 3: Healthy control group | Active comparator | Group receiving probiotics Receives: Dietary Supplement: Probiotics |
| Arm 4: Healthy control group | Placebo comparator | Group receiving placebo (corn starch) Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of fatigue symptoms
Improvement of fatigue as measured by validated psychometric questionnaires.
Measured: 3 months after end of chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2018
- Study start20 Jul 2021
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer Related FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universität des Saarlandes
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Jelden, University Hospital, Saarland
- Investigators
- Michael Jelden, MD, Principal investigator, University Hospital, Saarland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03773003
- Sponsor's protocol ID
- IMPROFA
- Acronym
- IMPROFA
- Status last verified
- May 2025
- First submitted
- 10 Dec 2018
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03773003
- Acronym / sponsor ID
- IMPROFA / IMPROFA
- Conditions
- Cancer Related Fatigue, Fatigue Syndrome, Chronic
- Keywords
- Cancer Fatigue, Chronic Fatigue
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Universität des SaarlandesUniversity, hospital or other
- Study start
- 20 Jul 2021 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 12 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
- 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
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Tumor disease w/o fatigue | Active comparator | Dietary Supplement: ProbioticsGroup receiving probiotics. |
| Arm 2: Tumor disease w/o fatigue | Placebo comparator | Dietary Supplement: PlaceboGroup receiving placebo (corn starch) |
| Arm 3: Healthy control group | Active comparator | Dietary Supplement: ProbioticsGroup receiving probiotics |
| Arm 4: Healthy control group | Placebo comparator | Dietary Supplement: PlaceboGroup receiving placebo (corn starch) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- histologically, cytologically or radiologically confirmed tumor disease
- indication for chemotherapy
- Written consent to participation
Key exclusion criteria (2 listed)
- chronic-inflammatory bowel disease
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbioticsThe 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 | Arm 1: Tumor disease w/o fatigue, Arm 3: Healthy control group |
| PlaceboIdentically looking to verum, containing corn starch. | Dietary supplement | Arm 2: Tumor disease w/o fatigue, Arm 4: Healthy control group |
Primary outcome
Improvement of fatigue symptoms
Time frame: 3 months after end of chemotherapy
Improvement of fatigue as measured by validated psychometric questionnaires.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
Related trials for Cancer Related Fatigue
Enrolling by invitation
Dance-Based Exercise for Cancer-Related Fatigue in Breast Cancer Patients
Breast Neoplasms
Not yet recruiting
Evaluation of Massage Therapy for Cancer Related Fatigue in Breast Cancer Survivors
Breast Cancer, Fatigue in Cancer Survivors
Recruiting
STEpwise Research Program to Promote INGeniouS ONline Supportive Solutions in the Relief of Cancer-related Fatigue
Cancer Diagnosis, Moderate or Severe Score of Cancer-related Fatigue (CRF)
Active, not recruitingPhase 2/3
Methylphenidate and Exercise in Reducing Cancer-Related Fatigue in Patients With Prostate Cancer
Prostate Carcinoma
RecruitingPhase 3
Methylphenidate in Pediatric Brain Tumor Survivors With Cancer-related Fatigue
Brain Tumor, Pediatric, Cancer-related Fatigue
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Jelden, MD principal investigator
University Hospital, Saarland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotics in people with Cancer Related Fatigue and Fatigue Syndrome, Chronic, run by Universität des Saarlandes at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Jelden, MD (+4968411630000, michael.jelden@uks.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of fatigue symptoms (time frame: 3 months after end of chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2025.