Correlates of CRCI and Gut Microbiome Dysbiosis; a Pilot Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Characterization of fecal microbiome using molecular methods at baseline [Time frame: Baseline]
- Characterization of fecal microbiome using molecular methods at 6 months [Time frame: 6 months]
Secondary outcome measures (6)
- 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]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- Females who are pregnant or lactating.
- Other medical conditions or medications deemed exclusionary by the study investigators.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- The University of Texas Medical Branch — Galveston
Identifiers
NCT: NCT06098404 · 23-0289