Histidine Supplementation for Antitumor Immunity in Colorectal Cancer

A Single-arm Clinical Study of Histidine Supplementation for Antitumor Immunity in Colorectal Cancer

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 Overview

• Status: Not yet recruiting
• Conditions: Colorectal Cancer
• Intervention / Treatment: Dietary supplement: Histidine

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wan Du, M.D.; Phone Number: (86)13788972966; Email: duwan2017@126.com
• Study Contact Backup: Name: Youli Chen; Phone Number: (86)13656503169; Email: chenylpetri@gmail.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China
      • Shanghai Punan Hospital of Pudong New District
      • Contact: Fengyuan Chen, M.D.; Phone Number: (86)18917107059; Email: cfengyuan0211@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Histidine supplement group; Patients with colorectal cancer will receive oral histidine supplementation in addition to standard anti-tumor treatment for 9 weeks.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum histidine concentration	Serum histidine concentration measured using liquid chromatography-mass spectrometry (LC-MS).	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.	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.	At the time of enrollment as baseline, and at the end of treatment at 9 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.

Collaborators and Investigators

• Sponsor: Jing-yuan Fang, MD, Ph. D
• Collaborators: Shanghai Punan Hospital of Pudong New District
• Investigators: Study Director: Jing-Yuan Fang, M.D., Division of Gastroenterology and Hepatology, NHC Key Laboratory of Digestive Diseases, Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: April 24, 2026
• First Submitted That Met QC Criteria: May 5, 2026
• First Posted (Actual): May 11, 2026

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Colorectal Cancer; Immune functions; Histidine
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms; Amino Acids, Peptides, and Proteins; Amino Acids; Amino Acids, Essential; Amino Acids, Cyclic; Histidine
• Other Study ID Numbers: (2025)YLD(024)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No