The Chemo-Gut Probiotic Trial for Cancer Survivors

NCT06088940 | Unknown

• 1 other identifier: HREBA.CC-22-0289
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

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. 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.

Conditions

Cancer; Psychosocial Problem; Gastrointestinal Dysfunction

Keywords

Gut microbiome; Patient Reported Outcomes; Probiotics; Cancer survivor

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (10)

• Effects of probiotic on Gas/Bloating symptoms

  12 weeks

• Effects of probiotic on Diarrhea symptoms

  12 weeks

• Effects of probiotic on Constipation symptoms

  12 weeks

• Effects of probiotic on anxiety symptoms

  12 weeks

• Effects of probiotic on Fatigue symptoms

  12 weeks

Other Outcomes (1)

• Relationships between bacterial taxa and symptoms

  12 weeks

Study Arms (2)

Probiotic Group (Group 1: Experimental intervention)

EXPERIMENTAL

Participants will be given a 12-week supply of the probiotic supplement and asked to take 1 capsule daily by mouth at the same time as their first meal of the day.

Dietary Supplement: Multistrain Probiotic

Placebo Group (Group 2: Control condition)

PLACEBO COMPARATOR

Participants will be given a 12-week supply of the placebo capsules and asked to take 1 capsule daily by mouth at the same time as their first meal of the day.

Other: Placebo

Interventions

Multistrain Probiotic DIETARY_SUPPLEMENT

The probiotic capsule contains Lactobacillus and Bifidobacterium strains, ingested orally once daily.

Probiotic Group (Group 1: Experimental intervention)

Placebo OTHER

Placebo is composed of maltodextrin, that is an identically formulated and packaged inactive substance

Placebo Group (Group 2: Control condition)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Calgary: lead

Related Publications (3)

• 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.

  PMID: 31870331 BACKGROUND

• 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.

  PMID: 36583068 BACKGROUND

• 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.

  PMID: 34844479 BACKGROUND

MeSH Terms

Conditions

Neoplasms

Study Officials

• Julie M Deleemans, PhD

  University of Calgary Cumming School of Medicine

  STUDY DIRECTOR

Central Study Contacts

Linda E Carlson, PhD

CONTACT

403-355-3207; l.carlson@ucalgary.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants will be randomized individually upon enrollment after completing baseline assessments into the probiotic or placebo condition in a 1:1 allocation ratio using a computer-generated stratified randomization strategy (to balance age and sex). Randomization sequence will be pre-determined by randomization software and sequential allocations prepared in sealed envelopes, only to be revealed to a research assistant after consent and baseline questionnaires are completed. Once randomized, a research assistant will be responsible for assigning the probiotic or placebo for each participant to their study package so that the study coordinator, who will have direct contact with patients, will remain blinded to participants' condition. A member of the study team who does not have contact with participants will also be provided a copy of the treatment allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Theoretical Framework: This line of research follows the NIH ORBIT model for intervention development. Briefly, the ORBIT model provides a generic, systematic framework that emphasizes using a set of studies to form a chain of evidence that ultimately indicates readiness for an efficacy trial. Study Design. Consistent with the National Institutes for Health (NIH) clinical trial phases for drug development, this study will fit into phase II, where investigators are focused on examining treatment effectiveness. A placebo-controlled randomized double-blinded study design is the gold standard for intervention research involving medications or natural health products, such as probiotics.

Study Record Dates

• First Submitted: May 18, 2023
• First Posted: October 18, 2023
• Study Start: November 10, 2023
• Primary Completion: November 30, 2024
• Study Completion: September 30, 2025
• Last Updated: October 18, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 1. The study protocol is anticipated to be published by/before winter 2023 2. Deidentified data will be made available to other researchers after primary data has been published (anticipated 2026)
• Access Criteria: Reasonable request to the PI