Recruiting nowNot phased
What this trial is trying to do
The researchers think that taking oral histidine, an amino acid, may support immune activity against colorectal cancer during standard treatment. This small study is testing whether a daily 2-gram supplement can be taken safely and whether it raises histidine levels in the blood.
The idea is that supporting antitumour immune function could improve the body's response to standard treatment, but this study is only measuring blood histidine levels, safety, and treatment assessments—not whether people live longer or their cancer stays controlled for longer.
Worth knowing: This is a small, non-randomised study without a comparison group, and its main outcome is a blood measurement rather than evidence of improved cancer outcomes.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
| Registry number | NCT07577505 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Not phased |
| Design | open label |
| Taking part | 20 people (planned) |
| Who can join | aged 18 Years to 80 Years |
| Run by | Jing-yuan Fang, MD, Ph. D |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Supplement Histidine
What it is measuring
Serum histidine concentration
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
Not phased. Not a drug-phase trial. Often a device, a procedure, or a change in how care is delivered.
How the researchers describe it
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.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Locally advanced
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
Inclusion Criteria
1. Patients aged 18-80 years, regardless of sex.
2. Body mass index (BMI) ≥18.5.
3. NRS-2002 score <3.
4. Diagnosed with stage II or higher colorectal cancer who require pharmacological intervention.
5. Capable of oral intake of medication.
6. Willing to participate in the study and provide written informed consent.
Exclusion Criteria
1. Participation in other interventional clinical trials (including drugs, nutritional supplements, medical devices, etc.) within 4 weeks prior to enrollment.
2. Presence of ascites, severe diarrhea, intractable vomiting, severe malabsorption syndrome, paralysis, mechanical intestinal obstruction, or active gastrointestinal bleeding.
3. Allergy to sample components.
4. Current use of other nutritional supplements that may affect the validity and effectiveness of the study results.
5. Pregnant, lactating female patients or women with fertility who test positive in the baseline pregnancy test.
6. Presence of cognitive impairments or mental illnesses that prevent understanding of the study procedures.
7. Presence of any other conditions, judged by the researcher, make the participant unsuitable for participation in the study.
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 1 site. Listed in: China.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT07577505, registered by Jing-yuan Fang, MD, Ph. D on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.