Probiotic Supplementation During Cytotoxic Chemotherapy for Solid Tumor Malignancies
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lactobacillus and Bifidobacterium, Placebo.
- Who it may be relevant to
- Registry conditions: Solid Tumor, Adult, Cytotoxicity. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized Placebo-controlled Feasibility Trial of Probiotic Supplementation During Adjuvant or Neoadjuvant Cytotoxic Chemotherapy for Solid Tumor Malignancies
Overview
This is a pilot single-blind placebo-controlled randomized trial to establish experimental feasibility. We plan on enrolling a pilot cohort of 40 patients, with up to 5 patients in treatment phase 0 and the remaining in treatment phase I. During Phase I, the remaining participants will be assigned to either treatment or control group using dynamic block randomization balancing on sex, age group, and disease histology.
Interventions
- Biological Lactobacillus and Bifidobacterium
Each lot of Lactobacillus and Bifidobacterium and placebo capsules to be used in this study will undergo bioburden testing (tested as per USP \<61\>) to ensure that each lot has: * Not more than 2000 colony forming unit (CFU) of contaminating (other than the seven strains of bacteria used in the Lactobacillus and Bifidobacterium capsules) aerobic bacteria per gram or dose (whichever is greater); * Not more than 200 CFU of yeasts and molds per gram or dose (whichever is greater); and * No bile-t - Other Placebo
Placebo capsule manufactured in same facility as experimental capsule.
Primary outcome measures
- Number of Participants at end of study [Time frame: Week 12]
Secondary outcome measures (1)
- Number of Adverse Events related to Cytotoxic Chemotherapy [Time frame: Week 12]
Eligibility criteria
Inclusion criteria
- Adults ≥18 years old
- Diagnosis of stage III colon cancer
- Undergoing chemotherapeutic treatment within the MHFV or MVAHC medical systems.
Exclusion criteria
- Allergy or sensitivity to probiotic supplementation
- Diagnosis/history of:
Non-colon GI cancer or chronic GI-related disease or disorders such as gastric ulcer, irritable bowel syndrome, inflammatory bowel disease, or intestinal malabsorption syndrome Cognitive impairment, such as dementia, or developmental disorder that would affect ability to give consent or comply with study procedures
- Current treatment of cancer other than non-melanoma skin cancer, including metastases and recurrences
- Current participation in another interventional study of medication(s)
- Major changes in eating habits within the past 3 months, such as stopping or starting a restricted diet
- BMI ≥40 kg/m2 or ≤17 kg/m2
- Unexpected change in weight of ˃4.5 kg within the past 6 months
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06772090 · 2023LS220