Status:
UNKNOWN
The Chemo-Gut Probiotic Trial for Cancer Survivors
Lead Sponsor:
University of Calgary
Conditions:
Cancer
Psychosocial Problem
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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. O...
Detailed Description
Background: Survivors of cancer experience chronic gastrointestinal (GI) and psychosocial health symptoms, and reduced gut microbial diversity. This may compromise survivors' long-term health and over...
Eligibility Criteria
Inclusion
- 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
- Evidence of clinically elevated levels (i.e. a score of 56 or higher) of GI and/or comorbid psychosocial symptoms as determined using PROMIS short forms for abdominal pain, gas/bloating, and general mental and physical health
- Able to provide stool samples
- Fluent in English, and have access to a computer, smartphone, or tablet with internet access to complete questionnaires
- Provide written informed consent
Exclusion
- Diagnosis of central nervous system tumor, or colorectal cancer
- Taken antibiotics and/or daily probiotic (including probiotic yogurt) within the 1 month prior to study participation
- Currently or previously receiving immunotherapy
- Diagnosed with irritable bowel syndrome or inflammatory bowel disease prior to being diagnosed with cancer
- Diagnosed with a developmental/cognitive delay prior to cancer (e.g. autism spectrum disorder, downs syndrome)
- Pregnancy
Key Trial Info
Start Date :
November 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2025
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT06088940
Start Date
November 10 2023
End Date
September 30 2025
Last Update
October 18 2023
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