Shanghai Punan Hospital of Pudong New District
Shanghai, Shanghai Municipality, China
Not Yet Recruiting
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.
Not Yet Recruiting
Trial opening soon.
Get NotifiedKey information
Conditions
Age range
18 year–80 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
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 SupplementHistidine 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
-
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).
-
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.
-
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
-
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
Youli Chen
CONTACT
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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