CancerNCT06098404
Correlates of CRCI and Gut Microbiome Dysbiosis; a Pilot Study
An observational study of Cancer, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
The aim of this study is to characterize the microbiome and assess fatigue and cognition of patients with cancer undergoing standard of care treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Mar 2024to Oct 2026
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects will be selected from community cancer clinics
Who may be able to join
- Current diagnosis of cancer.
- Ages 18 and over.
- Has access to a device (smart phone, computer, tablet) with internet access.
- Participant is willing and able to give informed consent for participation in the study.
Who cannot join
- Females who are pregnant or lactating.
- Other medical conditions or medications deemed exclusionary by the study investigators.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas Medical Branch
Galveston, Texas, 77555
Kate Randolph, BS, 409-223-7891, kmrandol@utmb.edu
Melinda Sheffield-Moore, PhD
About this study
The aim of this study is to characterize the microbiome and assess fatigue and cognition of patients with cancer undergoing standard of care treatment.
Read the detailed description
Cancer-related fatigue is experienced by nearly all patients during treatment, and cancer-related cognitive impairment (CRCI), which is a decrease in neurocognitive functioning that can be caused by cancer or its treatment, is present in up to ¾ of patients during treatment. Fatigue and CRCI have both been linked to the composition of the gut microbiome in cancer patients. CRCI is often reported as one of the most debilitating and life-altering aspects of cancer and treatment. Although CRCI is widely reported in patients with a variety of cancers and undergoing a variety of treatments, it is not clear if the mechanisms leading to symptoms are the same throughout. Using identical methods to monitor CRCI symptoms and microbial dysbiosis in a cross-section of various cancers, cancer stages, and treatments, can help to identify commonalities associated with symptoms.
Specific Aims
Specific Aim 1: Characterize the microbiome of cancer patients and compare to healthy control subjects from previous studies.
Specific Aim 2: Assess fatigue in cancer patients and determine associations with composition of the gut microbiome.
- Conditions
- Cancer
- Keywords
- Microbiome, Fatigue, Cognition
- Medical subject headings
- Neoplasms, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cancer Patients | Patients diagnosed with cancer undergoing standard of care treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterization of fecal microbiome using molecular methods at baseline
Characterization of the fecal microbiome using a commercially available sampling kit and our lab's patented array for PCR at baseline
Measured: Baseline
Characterization of fecal microbiome using molecular methods at 6 months
Characterization of the fecal microbiome using a commercially available sampling kit and our lab's patented array for PCR after 6 months of standard of care treatment.
Measured: 6 months
Secondary outcomes (6)
Cognitive Function as measured by Montreal Cognitive Assessment at baseline
The Montreal Cognitive Assessment (MoCA) is a rapid assessment of cognition. The MoCA-BLIND v8.1 will be used in this study as it can be administered in person as well as over the telephone. The MoCA-BLIND consists of 9 questions with the following subcategories: memory, attention, language, abstraction, delayed recall and orientation. The MoCA has been used extensively to detect cognitive impairment in many conditions, including head trauma. The MoCA will be administered by a certified tester at enrollment. Scores range from 0 to 22, higher score being a better outcome.
Measured: Baseline
Cognitive Function as measured by Montreal Cognitive Assessment at 6 months
The Montreal Cognitive Assessment (MoCA) is a rapid assessment of cognition. The MoCA-BLIND v8.2 will be used in this study as it can be administered in person as well as over the telephone. The MoCA-BLIND consists of 9 questions with the following subcategories: memory, attention, language, abstraction, delayed recall and orientation. The MoCA has been used extensively to detect cognitive impairment in many conditions, including head trauma. The MoCA will be administered by a certified tester at enrollment. Scores range from 0 to 22, higher score being a better outcome. The MoCA will be performed after 6 months of standard of care treatment.
Measured: 6 months
Fatigue and Cognition as measured by the Fatigue and Altered Cognition Scale at baseline
The Fatigue and Altered Cognition Scale (FACS) is a joint project from University of Texas Medical Branch and Texas A\&M University. The FACS is a 20 question assessment designed to access perceived fatigue and cognition.
There are 2 subscales used to calculate a total score. The subscales are: Fatigue and Altered Cognition. The total score is calculated by adding the subscales together. The range of the total score is 0-100, with a higher score indicating more fatigue and altered cognition.
Measured: Baseline
Fatigue and Cognition as measured by the Fatigue and Altered Cognition Scale at 6 months
The Fatigue and Altered Cognition Scale (FACS) is a joint project from University of Texas Medical Branch and Texas A\&M University. The FACS is a 20 question assessment designed to access perceived fatigue and cognition.
There are 2 subscales used to calculate a total score. The subscales are: Fatigue and Altered Cognition. The total score is calculated by adding the subscales together. The range of the total score is 0-100, with a higher score indicating more fatigue and altered cognition. The FACS will be performed after 6 months of standard of care treatment.
Measured: 6 months
Gastrointestinal Health measured by the Gastrointestinal Symptom Rating Scale at baseline
The Gastrointestinal Symptom Rating Scale (GSRS) is a specific 15-item questionnaire. Subjects are asked to numerically score their subjective symptoms on a scale of 1-7 (1 = no discomfort at all; 7 = very severe discomfort) . The sum of the scores for all 15 items is regarded as the GSRS total score. Total scores range from 15 (best outcome) to 105 (worst outcome).
Measured: Baseline
Gastrointestinal Health measured by the Gastrointestinal Symptom Rating Scale at 6 months.
The Gastrointestinal Symptom Rating Scale (GSRS) is a specific 15-item questionnaire. Subjects are asked to numerically score their subjective symptoms on a scale of 1-7 (1 = no discomfort at all; 7 = very severe discomfort) . The sum of the scores for all 15 items is regarded as the GSRS total score. Total scores range from 15 (best outcome) to 105 (worst outcome). The GSRS will be performed after 6 months of standard of care treatment.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start4 Mar 2024
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melinda Sheffield-Moore, PhD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06098404
- Sponsor's protocol ID
- 23-0289
- Status last verified
- Dec 2025
- First submitted
- 18 Oct 2023
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlates of CRCI and Gut Microbiome Dysbiosis; a Pilot Study
- ClinicalTrials.gov ID
- NCT06098404
- Acronym / sponsor ID
- 23-0289
- Conditions
- Cancer
- Keywords
- Microbiome, Fatigue, Cognition
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 24 Oct 2023 (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.
The aim of this study is to characterize the microbiome and assess fatigue and cognition of patients with cancer undergoing standard of care treatment.
Detailed description
Cancer-related fatigue is experienced by nearly all patients during treatment, and cancer-related cognitive impairment (CRCI), which is a decrease in neurocognitive functioning that can be caused by cancer or its treatment, is present in up to ¾ of patients during treatment. Fatigue and CRCI have both been linked to the composition of the gut microbiome in cancer patients. CRCI is often reported as one of the most debilitating and life-altering aspects of cancer and treatment. Although CRCI is widely reported in patients with a variety of cancers and undergoing a variety of treatments, it is not clear if the mechanisms leading to symptoms are the same throughout. Using identical methods to monitor CRCI symptoms and microbial dysbiosis in a cross-section of various cancers, cancer stages, and treatments, can help to identify commonalities associated with symptoms.
Specific Aims
Specific Aim 1: Characterize the microbiome of cancer patients and compare to healthy control subjects from previous studies.
Specific Aim 2: Assess fatigue in cancer patients and determine associations with composition of the gut microbiome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cancer Patients | – | –Patients diagnosed with cancer undergoing standard of care treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be selected from community cancer clinics
Key inclusion criteria (4 listed)
- Current diagnosis of cancer.
- Ages 18 and over.
- Has access to a device (smart phone, computer, tablet) with internet access.
- Participant is willing and able to give informed consent for participation in the study.
Key exclusion criteria (2 listed)
- Females who are pregnant or lactating.
- Other medical conditions or medications deemed exclusionary by the study investigators.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Characterization of fecal microbiome using molecular methods at baseline
Time frame: Baseline
Characterization of the fecal microbiome using a commercially available sampling kit and our lab's patented array for PCR at baseline
Characterization of fecal microbiome using molecular methods at 6 months
Time frame: 6 months
Characterization of the fecal microbiome using a commercially available sampling kit and our lab's patented array for PCR after 6 months of standard of care treatment.
6 secondary outcomes
Cognitive Function as measured by Montreal Cognitive Assessment at baseline
Time frame: Baseline
Cognitive Function as measured by Montreal Cognitive Assessment at 6 months
Time frame: 6 months
Fatigue and Cognition as measured by the Fatigue and Altered Cognition Scale at baseline
Time frame: Baseline
Fatigue and Cognition as measured by the Fatigue and Altered Cognition Scale at 6 months
Time frame: 6 months
Gastrointestinal Health measured by the Gastrointestinal Symptom Rating Scale at baseline
Time frame: Baseline
Gastrointestinal Health measured by the Gastrointestinal Symptom Rating Scale at 6 months.
Time frame: 6 months
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 16 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Melinda Sheffield-Moore, PhD principal investigator
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
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 4 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 16 Dec 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 United States. 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. 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 Kate Randolph, BS (409-223-7891, kmrandol@utmb.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterization of fecal microbiome using molecular methods at baseline (time frame: Baseline). The study lists 2 primary outcomes in all. 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 16 Dec 2025.