Histidine supplementation to support immune function in colorectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study will give 2 g of oral histidine daily to adults with colorectal cancer during their usual treatment. Participants will provide blood samples before and after supplementation and will attend regular follow-up visits for safety checks and treatment evaluation. The goal is to see if histidine can safely support immune function against the tumor during standard therapy. The study will monitor for adverse effects and any changes in treatment outcomes. It is conducted at Shanghai Punan Hospital of Pudong New District in Shanghai.

Why it matters

Who can join: the full rules

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.

Where it's running

• Shanghai Punan Hospital of Pudong New District
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Wan Du, M.D.
• Email: duwan2017@126.com
• Phone: (86)13788972966

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.