Cancer (Colon Cancer, Breast Cancer, Lymphoma, Chronic Lymphoma Leukemia, Multiple Myeloma)
Conditions
Keywords
Colorectal cancer surgery, Postbiotic, colorectal cancer, intestinal microbiota, nutritional intervention, inflammation
Brief summary
The treatment of colorectal cancer, in the absence of metastases, is primarily based on surgical removal. Colorectal surgery, which involves resecting part of the intestine and restoring intestinal continuity, carries a risk of complications. This study aims to evaluate whether oral supplementation with a postbiotic at a dose of 900 mg for 7 days prior to surgery reduces the rate of postoperative complications.
Detailed description
Recent studies have underscored the influence of gut microbiota composition on the incidence of postoperative complications following intestinal surgery. Microorganisms naturally present in the intestinal environment produce a variety of substances that may exert either beneficial or detrimental effects on human health. Emerging evidence indicates a protective role for metabolites derived from these microorganisms. Pharmacological modulation of these metabolites for human supplementation has led to the development of postbiotics. Recent research has demonstrated that certain postbiotics, particularly short-chain fatty acids such as butyrate, possess immunomodulatory properties and contribute to maintaining the integrity of the intestinal barrier in inflammatory bowel disease. This study will include two groups of participants: one group will receive a daily supplementation of 900 mg of butyrate, while the other will receive a placebo, for seven days prior to surgery. A total of 164 participants are expected to be enrolled, and the study will be conducted over a two-year period. The present proposal aims to assess the effectiveness of a postbiotic in reducing postoperative complications in colorectal cancer surgery, with an anticipated 50% reduction in the overall postoperative complication rate in the intervention arm. If confirmed, such a reduction would represent a substantial decrease in morbidity and healthcare costs throughout the treatment pathway for this specific population.
Interventions
DIETARY_SUPPLEMENTPostbiotic
Butyrate directly influences the gastrointestinal microbiota and exhibits potent anti-inflammatory effects by locally inhibiting inflammatory mediators in the intestinal epithelium, thereby enhancing mucosal barrier integrity. It also mitigates excessive inflammation through the modulation of immune cells, promoting the activity of M2 macrophages and regulatory T cells. Furthermore, butyrate is thought to modulate intestinal receptor hypersensitivity, leading to reduced intraluminal pressure and improved peristaltic function. This mechanism may underlie its therapeutic role in clinical conditions associated with diarrhea and in preventing the loss of water, sodium, chloride, and potassium.
OTHERPlacebo
Participants will receive three oral capsules per day, containing no active substance and identical in appearance to the study capsules, for seven consecutive days.
Sponsors
AC Camargo Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Individuals diagnosed with malignant neoplasm of the large intestine, specifically adenocarcinoma. * Patients over 18 years of age, of both sexes. * Patients who agree to participate in the study and sign the informed consent form.
Exclusion criteria
* Emergency or urgent surgeries. * Cytoreductive surgeries involving intraoperative intraperitoneal chemotherapy. * Extended surgeries for the treatment of recurrent tumors.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative complications within 30 days (Clavien-Dindo grade II or higher) | 30 days after colorectal cancer surgery | Clinical or surgical postoperative complication - Clavien-Dindo grade II or higher . |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| C-reactive protein (CRP) levels after surgery | Baseline (within 7 days before surgery) and postoperative day 3 | Serum C-reactive protein (CRP) concentration (mg/L) measured preoperatively (within 7 days before surgery) and on postoperative day 3. The primary comparison will be the CRP level on postoperative day 3 between the postbiotic and control groups, as well as the change in CRP from baseline to postoperative day 3. |
| Gastrointestinal postoperative complications (Clavien-Dindo grade II or higher) | 30 days after surgery | Gastrointestinal postoperative complication : Clavien-Dindo grade II or higher within 30 days after colorectal cancer surgery (including, for example, prolonged postoperative ileus, bowel subocclusion or obstruction, anastomotic leakage, enteric fistula, intra-abdominal abscess, or gastrointestinal bleeding requiring intervention). |
| Nutritional status and body composition assessed by preoperative computed tomography | Baseline (preoperative CT scan performed within 8 weeks before surgery); postoperative complications assessed within 30 days after surgery | Preoperative body composition assessment will be performed using abdominal computed tomography scans obtained for colorectal cancer staging. Skeletal muscle area at the level of L3, skeletal muscle index (SMI), and visceral adipose tissue area will be quantified. The prevalence of sarcopenia, visceral obesity, and sarcopenic obesity will be described, and the associations between these body composition phenotypes and postoperative complications within 30 days will be explored. |
| Dietary intake assessment using a Food Frequency Questionnaire (FFQ) | Baseline (preoperative assessment); postoperative complications assessed within 30 days. | Habitual dietary intake will be assessed preoperatively using a validated Food Frequency Questionnaire (FFQ). Associations between identified dietary intake patterns and postoperative complications within 30 days will be explored, as well as potential interactions between habitual diet and the response to preoperative postbiotic supplementation. |
Countries
Brazil
Contacts
Primary ContactSamuel A Junior, MD, PhD
Backup ContactBruna E Catin Kupper, PhD
Outcome results
None listed