Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-25 @ 2:10 AM
NCT ID:
NCT05039060
Eligibility Criteria:
Inclusion Criteria:
1. Histologically or cytologically confirmed colorectal adenocarcinoma patients after curative surgery without post-operative chemotherapy (stage I and low-risk stage II)
2. Male of female participants over the age of 19
3. Eastern Cooperative Oncology Group (ECOG) performance score 0-2
4. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol
5. Adequate hematologic and end-organ function
Exclusion Criteria:
1. Patients with temporary/permanent stoma after surgery
2. Diagnosed with locally advanced stage (more than high-risk stage II) colorectal cancer which require postoperative chemotherapy after surgery
3. Diagnosed with metastatic stage IV colorectal cancer after surgery
4. Uncontrolled diabetes (glycated hemoglobin A1c (HbA1c) \> 8.0 g/dl)
5. Active infection requiring antibiotics, antifungal or antiviral agents or received a course of antibiotics within 4 weeks prior to study treatments
6. Known history of food allergy
7. Known history of uncontrolled intercurrent illness including but not limited to: Infection/inflammation; severe liver dysfunction; bilateral interstitial lung disease; uncontrolled kidney disease; clinically significant (active) cardiovascular and pulmonary disease; hemorrhagic disease; inflammatory bowel disease, intestinal obstruction; Inability to swallow food; social and psychological problems etc.)
8. Other medical and psychiatric conditions that would prohibit the understanding or rendering of informed consent which affect study compliance
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT05039060
Study Brief:
Protocol Section:
NCT05039060