Histidine Supplementation for Antitumor Immunity in Colorectal Cancer

NCT07577505 | Not Yet Recruiting

• 1 other identifier: (2025)YLD(024)
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colorectal Cancer

Keywords

Colorectal Cancer; Histidine; Immune functions

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Tumor volume

  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.

Study Arms (1)

Histidine supplement group

EXPERIMENTAL

Patients with colorectal cancer will receive oral histidine supplementation in addition to standard anti-tumor treatment for 9 weeks.

Dietary Supplement: Histidine

Interventions

Histidine DIETARY_SUPPLEMENT

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.

Histidine supplement group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jing-yuan Fang, MD, Ph. D: lead
• Shanghai Punan Hospital of Pudong New District: collaborator

Study Sites (1)

Shanghai Punan Hospital of Pudong New District

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Histidine

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential

Study Officials

• 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 DIRECTOR

Central Study Contacts

Wan Du, M.D.

CONTACT

(86)13788972966; duwan2017@126.com

Youli Chen

CONTACT

(86)13656503169; chenylpetri@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor Dr. Jing-yuan Fang

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: May 11, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 11, 2026

Record last verified: 2026-05

Locations

CN (1)