The Chemo-Gut Probiotic Trial for Cancer Survivors (NCT06088940) | Clinical Trial Compass
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The Chemo-Gut Probiotic Trial for Cancer Survivors
66 participantsStarted 2023-11-10
Plain-language summary
Purpose: The goal of this clinical trial is to determine whether probiotics can reduce gastrointestinal and psychosocial symptoms in post-treatment cancer survivors by impacting the gut microbiome.
Objectives: The main questions the investigators aim to answer are:
* Does taking the probiotic reduce gastrointestinal (e.g. belly pain) and psychosocial (e.g. depressive symptoms, fatigue) symptoms, and impact the gut microbiome?
* What relationships exist between gut bacteria, gastrointestinal, and psychosocial symptoms?
Methods: The study team will investigate this by giving a group of adult post-treatment cancer survivors either a probiotic capsule (intervention) or placebo capsule (control) over 12 weeks. Investigators will then analyze the bacterial diversity in participants' stool samples before and after these 12 weeks to see how the bacterial composition changed due to the treatment. Surveys will be used to ask participants questions about their physical and mental health, including specific gastrointestinal and psychosocial symptoms.
Implications: Cancer recovery is tough enough, and to minimize treatment-related long-term effects through a simple probiotic capsule would immensely improve the well-being and health of survivors.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male, female, and non-binary, any ethnicity
✓. Aged 18 years or older
✓. Diagnosed with hematological cancers (leukemia, Hodgkin's, and non-Hodgkin lymphoma), breast, osteosarcoma, Ewing's sarcoma, gynecological (cervical, endometrial), prostate, or testicular
✓. Stages I - IV, including metastatic if stable and off treatment
✓. Have received chemotherapy (with or without radiation, surgery, or hormone therapy)
✓. Have completed primary cancer treatments
✓. Within 5 years from their final cancer treatments, with emphasis placed on recruiting those within the first year post-treatment
✓. Not currently pregnant or planning to become pregnant during the 12-week study
Exclusion criteria
✕. Diagnosis of central nervous system tumor, or colorectal cancer