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| Name | Class |
|---|---|
| Shanghai Punan Hospital of Pudong New District | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Histidine supplement group | Experimental | Patients with colorectal cancer will receive oral histidine supplementation in addition to standard anti-tumor treatment for 9 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wan Du, M.D. | Contact | (86)13788972966 | duwan2017@126.com | |
| Youli Chen | Contact | (86)13656503169 | chenylpetri@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Punan Hospital of Pudong New District | Shanghai | Shanghai Municipality | China |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D006639 | Histidine |
| ID | Term |
|---|---|
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |