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NCT06098404 | RECRUITING | Cancer


Correlates of CRCI and Gut Microbiome Dysbiosis; a Pilot Study
Sponsor:

The University of Texas Medical Branch, Galveston

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.

Condition or disease

Cancer

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 Type : OBSERVATIONAL
Estimated Enrollment : 250 participants
Official Title : Correlates of CRCI and Gut Microbiome Dysbiosis; a Pilot Study
Actual Study Start Date : 2024-03-04
Estimated Primary Completion Date : 2025-10
Estimated Study Completion Date : 2025-10

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.

Correlates of CRCI and Gut Microbiome Dysbiosis; a Pilot Study

Location Details

NCT06098404


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Locations


RECRUITING

United States, Texas

The University of Texas Medical Branch

Galveston, Texas, United States, 77555

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