Colorectal Cancer
Conditions
Keywords
Colorectal Cancer, Histidine, Immune functions
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.
Interventions
DIETARY_SUPPLEMENTHistidine
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.
Sponsors
Jing-yuan Fang, MD, Ph. D
Shanghai Punan Hospital of Pudong New District
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum histidine concentration | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| 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. | Tumor volume will be assessed using available imaging examinations and/or colonoscopy findings, according to routine clinical evaluation in patients with colorectal cancer. |
Countries
China
Contacts
CONTACTWan Du, M.D.
CONTACTYouli Chen
STUDY_DIRECTORJing-Yuan Fang, M.D.
Division of Gastroenterology and Hepatology, NHC Key Laboratory of Digestive Diseases, Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Outcome results
None listed