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NCT Number: NCT07577505

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Punan Hospital of Pudong New District

Shanghai, Shanghai Municipality, China

Location contact

Fengyuan Chen, M.D.

CONTACT

[email protected]

(86)18917107059

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Serum histidine concentration

    Time frame: At the time of enrollment as baseline, and at the end of treatment at 9 weeks.

    Serum histidine concentration measured using liquid chromatography-mass spectrometry (LC-MS).

  2. 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.

    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.

  3. 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.

    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.

Secondary outcomes

  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.

    Tumor volume will be assessed using available imaging examinations and/or colonoscopy findings, according to routine clinical evaluation in patients with colorectal cancer.

Study contacts

Contact information is provided by the study sponsor or research team.

Wan Du, M.D.

CONTACT

[email protected]

(86)13788972966

Youli Chen

CONTACT

[email protected]

(86)13656503169

Sponsors and collaborators

Lead sponsor

Jing-yuan Fang, MD, Ph. D

Other

Collaborators

  • Shanghai Punan Hospital of Pudong New District

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
May 11, 2026
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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