Phase 3 Colorectal Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 18 to 65 years old who are willing to give their consent to take part in the study.
• People who have been diagnosed with colorectal cancer that has spread to other parts of the body (metastatic), and who are planned to receive standard chemotherapy for at least 6 cycles.
• People with a confirmed diagnosis of metastatic colorectal cancer, confirmed according to standard medical guidelines.
• People who have at least one tumour that is 1 centimetre or larger in size, visible on a CT scan or MRI.
• People whose overall physical functioning is rated at a level of 0, 1, or 2 on a standard medical scale used to measure how much cancer affects daily activity (confirm with trial site).
• People who, in the doctor's judgement, are expected to live for at least 6 months.
• People whose haemoglobin (a measure of red blood cells) is at least 9 g/dL throughout the screening period.
• People who have other stable health conditions such as type 2 diabetes or high blood pressure, provided the treating doctor considers these to be well managed.

Who may not be able to join:

• People who have an untreated medical condition (such as an infection, hormonal imbalance, or metabolic issue) that could cause tiredness, in the doctor's judgement.
• People who are not able to understand the local language used in the questionnaires and rating scales required by the study.
• People who have taken stimulant medications (such as dextroamphetamine or methylphenidate) during the screening period, or any medication that could interfere with the study drug.
• People whose chemotherapy start is delayed so much that the screening period goes beyond 21 days.
• People whose cancer has spread to the brain or central nervous system.
• People who have a serious or uncontrolled non-cancer illness, or a psychiatric condition, that the doctor believes could affect safety or participation in the study.
• People who are pregnant or breastfeeding.
• People who have a known hepatitis B, hepatitis C, or HIV infection.
• People who have nausea, vomiting, or a digestive condition severe enough to affect how the body absorbs the study drug, in the doctor's opinion.
• People whose pain is not well controlled, where the treating doctor does not consider them suitable for the study.
• People who have a known allergy or sensitivity to rosmarinic acid, caffeic acid, related compounds, or any ingredients in the study treatment (Nuvastatic® 300 mg) or its placebo.
• People who are planned to take part in another clinical trial during this study.
• People who have taken part in another clinical trial or received an experimental treatment within 4 weeks before screening, or who plan to do so during the study period.

Important: Always verify eligibility with the trial site directly before applying.