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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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.
Shanghai Punan Hospital of Pudong New District
Shanghai, Shanghai Municipality, China
RECRUITINGSerum histidine concentration
Serum histidine concentration measured using liquid chromatography-mass spectrometry (LC-MS).
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
Peripheral blood mononuclear cells (PBMCs) collected from patients with colorectal cancer will be assessed by flow cytometry to evaluate the percentage of IFN-gamma-positive T cells as a T cell effector function marker.
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
Peripheral blood mononuclear cells (PBMCs) collected from patients with colorectal cancer will be assessed by flow cytometry to evaluate the percentage of granzyme B-positive T cells as a T cell effector function marker.
Time frame: At the time of enrollment as baseline, and at the end of treatment at 9 weeks.
Tumor volume
Tumor volume will be assessed using available imaging examinations and/or colonoscopy findings, according to routine clinical evaluation in patients with colorectal cancer.
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.
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