Clinical trial NCT06098404: Correlates of CRCI and Gut Microbiome Dysbiosis; a Pilot Study
Official title: Correlates of CRCI and Gut Microbiome Dysbiosis; a Pilot Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Keywords: Microbiome
Fatigue
Cognition
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
First posted: 2023-10-24
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be selected from community cancer clinics

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Current diagnosis of cancer.
2. Ages 18 and over.
3. Has access to a device (smart phone, computer, tablet) with internet access.
4. Participant is willing and able to give informed consent for participation in the study.

Exclusion Criteria:

1. Females who are pregnant or lactating.
2. Other medical conditions or medications deemed exclusionary by the study investigators.

Primary outcomes:
measure: Characterization of fecal microbiome using molecular methods at baseline
timeFrame: Baseline
measure: Characterization of fecal microbiome using molecular methods at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Cognitive Function as measured by Montreal Cognitive Assessment at baseline
timeFrame: Baseline
measure: Cognitive Function as measured by Montreal Cognitive Assessment at 6 months
timeFrame: 6 months
measure: Fatigue and Cognition as measured by the Fatigue and Altered Cognition Scale at baseline
timeFrame: Baseline
measure: Fatigue and Cognition as measured by the Fatigue and Altered Cognition Scale at 6 months
timeFrame: 6 months
measure: Gastrointestinal Health measured by the Gastrointestinal Symptom Rating Scale at baseline
timeFrame: Baseline
measure: Gastrointestinal Health measured by the Gastrointestinal Symptom Rating Scale at 6 months.
timeFrame: 6 months
Other outcomes:
Locations:
city: Galveston
country: United States
facility: The University of Texas Medical Branch
state: Texas
Study officials:
affiliation: University of Texas
name: Melinda Sheffield-Moore, PhD
role: PRINCIPAL_INVESTIGATOR
References: