Cancer Clinical Trial
Official title:
The Chemo-Gut Trial: A Double-blind Randomized Controlled Trial Investigating the Effects of a Multi-strain Probiotic on Gut Microbiota, Gastrointestinal Symptoms, and Psychosocial Health in Cancer Survivors
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.
Status | Not yet recruiting |
Enrollment | 66 |
Est. completion date | September 30, 2025 |
Est. primary completion date | November 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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University of Calgary |
Deleemans JM, Chleilat F, Reimer RA, Henning JW, Baydoun M, Piedalue KA, McLennan A, Carlson LE. The chemo-gut study: investigating the long-term effects of chemotherapy on gut microbiota, metabolic, immune, psychological and cognitive parameters in young adult Cancer survivors; study protocol. BMC Cancer. 2019 Dec 23;19(1):1243. doi: 10.1186/s12885-019-6473-8. — View Citation
Deleemans JM, Gajtani Z, Baydoun M, Reimer RA, Piedalue KA, Carlson LE. The Use of Prebiotic and Probiotic Interventions for Treating Gastrointestinal and Psychosocial Health Symptoms in Cancer Patients and Survivors: A Systematic Review. Integr Cancer Ther. 2021 Jan-Dec;20:15347354211061733. doi: 10.1177/15347354211061733. — View Citation
Deleemans JM, Toivonen K, Reimer RA, Carlson LE. The Chemo-Gut Study: A Cross-Sectional Survey Exploring Physical, Mental, and Gastrointestinal Health Outcomes in Cancer Survivors. Glob Adv Health Med. 2022 Dec 21;11:2164957X221145940. doi: 10.1177/2164957X221145940. eCollection 2022. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Relationships between bacterial taxa and symptoms | Measure: Scores for symptom outcomes will be correlated with bacterial operational taxonomic units (ASVs) using Spearman's rho for non-parametric data | 12 weeks | |
Primary | Effects of probiotic on abdominal pain | Endpoint: Clinically meaningful effects will be defined as reductions of 3 points or more from baseline scores of abdominal pain symptoms on PROMIS measures.
Measure: PROMIS Belly Pain - Scale v1.0, 5a; Scores range from 20 to 80. Higher scores >60 indicate more symptoms. |
12 weeks | |
Primary | Effects of probiotic on depression symptoms | Endpoint: Clinically meaningful effects will be defined as reductions of 3 points or more from baseline scores of depression on PROMIS measures.
Measure: PROMIS Ca Item Bank v1.0 - Emotional Distress - Depression questionnaire; Scores range from 20 to 80. Higher scores >60 indicate more symptoms. |
12 weeks | |
Secondary | Effects of probiotic on Gas/Bloating symptoms | Endpoint: Effects of probiotics on: Gas/bloating Measure: PROMIS Gas and Bloating - Scale v1.1 13a | 12 weeks | |
Secondary | Effects of probiotic on Diarrhea symptoms | Endpoint: Effects of probiotics on: Diarrhea Measure: PROMIS Diarrhea - Scale v1.0, 6a | 12 weeks | |
Secondary | Effects of probiotic on Constipation symptoms | Endpoint: Effects of probiotics on: Constipation Measure: PROMIS constipation - Scale v1.0, 9a | 12 weeks | |
Secondary | Effects of probiotic on anxiety symptoms | PROMIS Anxiety: v1.0 - Anxiety - Short Form 8a; Scores range from 20 to 80. Higher scores >60 indicate more symptoms. | 12 weeks | |
Secondary | Effects of probiotic on Fatigue symptoms | PROMIS v1.0 - Fatigue - Short Form 8a. Scores range from 20 to 80. Higher scores >60 indicate more symptoms. | 12 weeks | |
Secondary | Effects of probiotic on cognitive function | Measure: PROMIS v2.0 - Cognitive Function; Scores range from 80 (high function) to 20 (severe dysfunction). | 12 weeks | |
Secondary | Effects of probiotic on global health symptoms | Measure: PROMIS Global Health - Scale v1.2; Scores range from 80 (Excellent health) to 20 (Poor health). | 12 weeks | |
Secondary | Probiotic effects on gut microbiota alpha diversity composition | Measure: Chao1, Shannon, and Simpson index for statistically significant differences in alpha diversity between groups | 12 weeks | |
Secondary | Probiotic effects on gut microbiota beta diversity composition | Measure: Bray-Curtis index for statistically significant differences in beta diversity between groups | 12 weeks | |
Secondary | Probiotic effects on gut microbiota differential taxonomic abundance | Measure: statistically significant differences in differential taxonomic abundance (ASV's) between groups | 12 weeks |
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