Histidine Supplementation for Antitumor Immunity in Colorectal Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Histidine.
- Who it may be relevant to
- Registry conditions: Colorectal Cancer. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Single-arm Clinical Study of Histidine Supplementation for Antitumor Immunity in Colorectal Cancer
Overview
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.
Interventions
- Dietary supplement Histidine
Histidine capsules, 1000 mg per capsule, taken orally as 2 capsules once daily for 9 weeks. Histidine supplementation will be administered in addition to standard anti-tumor treatment determined by the treating physician according to clinical guidelines.
Primary outcome measures
- Serum histidine concentration [Time frame: At the time of enrollment as baseline, and at the end of treatment at 9 weeks.]
- Percentage of IFN-gamma-positive T cells [Time frame: At the time of enrollment as baseline, and at the end of treatment at 9 weeks.]
- Percentage of granzyme B-positive T cells [Time frame: At the time of enrollment as baseline, and at the end of treatment at 9 weeks.]
Secondary outcome measures (1)
- Tumor volume [Time frame: At the time of enrollment as baseline, and at the end of treatment at 9 weeks, and during follow-up at 3 and 6 months.]
Eligibility criteria
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.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shanghai Punan Hospital of Pudong New District — Shanghai
Identifiers
NCT: NCT07577505 · (2025)YLD(024)