The Chemo-Gut Probiotic Trial for Cancer Survivors

Launched by UNIVERSITY OF CALGARY · Oct 12, 2023

Keywords

ClinConnect Summary

The Chemo-Gut Probiotic Trial for Cancer Survivors is a study designed to see if taking probiotics—beneficial bacteria that can help with digestion—can improve gastrointestinal problems like belly pain and mental health issues such as fatigue and depression in people who have finished cancer treatment. The research will involve adult cancer survivors who are at least 18 years old and have completed their primary cancer treatments. Participants will either receive a probiotic capsule or a placebo (a capsule with no active ingredients) for 12 weeks, and researchers will analyze stool samples and conduct surveys to understand how these treatments affect their gut health and overall well-being.

To be eligible, participants should have been diagnosed with certain types of cancers, like breast cancer or leukemia, and must be within five years of completing their treatment, ideally in the first year after treatment. They should also be experiencing significant digestive and mental health symptoms. This trial aims to provide valuable insights that could help improve the quality of life for cancer survivors, making recovery a bit easier by addressing some of the long-term side effects of cancer treatment through a simple probiotic capsule.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male, female, and non-binary, any ethnicity
• • 2. Aged 18 years or older
• • 3. Diagnosed with hematological cancers (leukemia, Hodgkin's, and non-Hodgkin lymphoma), breast, osteosarcoma, Ewing's sarcoma, gynecological (cervical, endometrial), prostate, or testicular
• • 4. Stages I - IV, including metastatic if stable and off treatment
• • 5. Have received chemotherapy (with or without radiation, surgery, or hormone therapy)
• • 6. Have completed primary cancer treatments
• • 7. Within 5 years from their final cancer treatments, with emphasis placed on recruiting those within the first year post-treatment
• • 8. Not currently pregnant or planning to become pregnant during the 12-week study
• • 9. 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
• • 10. Able to provide stool samples
• • 11. Fluent in English, and have access to a computer, smartphone, or tablet with internet access to complete questionnaires
• • 12. Provide written informed consent
• Exclusion Criteria:
• • 1. Diagnosis of central nervous system tumor, or colorectal cancer
• • 2. Taken antibiotics and/or daily probiotic (including probiotic yogurt) within the 1 month prior to study participation
• • 3. Currently or previously receiving immunotherapy
• • 4. Diagnosed with irritable bowel syndrome or inflammatory bowel disease prior to being diagnosed with cancer
• • 5. Diagnosed with a developmental/cognitive delay prior to cancer (e.g. autism spectrum disorder, downs syndrome)
• • 6. Pregnancy