Histidine Supplementation for Antitumor Immunity in Colorectal Cancer (NCT07577505) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Histidine Supplementation for Antitumor Immunity in Colorectal Cancer
China20 participantsStarted 2026-05
Plain-language summary
The goal of this clinical study is to learn whether oral histidine supplementation may be safely used to support antitumor immune function during standard colorectal cancer treatment.
Participants with colorectal cancer in the supplementation group will:
Take 2g oral histidine once daily during standard colorectal cancer treatment; Provide blood samples before and after supplementation; Attend regular follow-up visits for laboratory tests, safety assessment, and treatment evaluation.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients aged 18-80 years, regardless of sex.
. Body mass index (BMI) ≥18.5.
. NRS-2002 score \<3.
. Diagnosed with stage II or higher colorectal cancer who require pharmacological intervention.
. Capable of oral intake of medication.
. Willing to participate in the study and provide written informed consent.
Exclusion criteria
. Participation in other interventional clinical trials (including drugs, nutritional supplements, medical devices, etc.) within 4 weeks prior to enrollment.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Serum histidine concentration
Timeframe: At the time of enrollment as baseline, and at the end of treatment at 9 weeks.
2
Percentage of IFN-gamma-positive T cells
Timeframe: At the time of enrollment as baseline, and at the end of treatment at 9 weeks.
3
Percentage of granzyme B-positive T cells
Timeframe: At the time of enrollment as baseline, and at the end of treatment at 9 weeks.
. Presence of ascites, severe diarrhea, intractable vomiting, severe malabsorption syndrome, paralysis, mechanical intestinal obstruction, or active gastrointestinal bleeding.
. Allergy to sample components.
. Current use of other nutritional supplements that may affect the validity and effectiveness of the study results.
. Pregnant, lactating female patients or women with fertility who test positive in the baseline pregnancy test.
. Presence of cognitive impairments or mental illnesses that prevent understanding of the study procedures.
. Presence of any other conditions, judged by the researcher, make the participant unsuitable for participation in the study.