Clinical trial · Interventional
Histidine Supplementation for Antitumor Immunity in Colorectal Cancer
A Single-arm Clinical Study of Histidine Supplementation for Antitumor Immunity in Colorectal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Histidine | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Histidine supplement group
- description
- Patients with colorectal cancer will receive oral histidine supplementation in addition to standard anti-tumor treatment for 9 weeks.
- interventionNames
- Dietary Supplement: Histidine
Primary outcomes (3)
- measure
- Serum histidine concentration
- timeFrame
- At the time of enrollment as baseline, and at the end of treatment at 9 weeks.
- description
- Serum histidine concentration measured using liquid chromatography-mass spectrometry (LC-MS).
- measure
- Percentage of IFN-gamma-positive T cells
- timeFrame
- At the time of enrollment as baseline, and at the end of treatment at 9 weeks.
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available