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A Randomized Controlled Clinical Study of the Clinical Effect of Tumor Complete Nutritional Formula for Special Medical Purposes in Postoperative Chemotherapy Patients With Stage II/III Colorectal Cancer

A Randomized Controlled Clinical Study of the Clinical Effect of Tumor Complete Nutritional Formula for Special Medical Purposes in Postoperative Chemotherapy Patients With Stage II/III Colorectal Cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500097323
Enrollment
Unknown
Registered
2025-02-17
Start date
2025-02-18
Completion date
Unknown
Last updated
2025-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stage II/III colorectal cancer

Interventions

Experimental group:During the period from 5 days postoperatively to 42 days before the second chemotherapy, the subjects followed a goal-directed nutritional support strategy for nutritional managemen
Control group:During the period of 5 days after surgery to 42 days before the second chemotherapy, participants followed a goal-directed nutritional support strategy for nutritional management, but th

Sponsors

Qilu Hospital of Shandong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Patients with stage II/III CRC diagnosed by histology or cytology 5-7 days after colorectal cancer; (2) Age 18-80 years old (including boundary value), male or female and ethnic group; (3) Patients who need chemotherapy after surgery, and are currently in stable disease status and in good general physical condition; (4) Subjects who need nutritional therapy according to the judgment of the investigator; (5) Those who can tolerate enteral nutrition; (6) Expected survival >=3 months; (7) Those who voluntarily participate in clinical trials and sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Patients who have undergone chemoradiotherapy in the past; (2) subjects who do not require artificial nutrition support; (3) There are diseases that seriously affect the digestion and absorption of the test products; (4) Subjects who are expected to not be able to take the trial product according to the regulations, and subjects who are not expected to reach the prescribed dosage as required, such as subjects who cannot be controlled after surgery and chemotherapy with severe nausea and vomiting; (5) Those who cannot tolerate enteral nutrition; (6) Known allergy to the ingredients contained in the products of the experimental group; (7) Participated in other interventional clinical trials (including drugs, nutritional preparations, medical devices, etc.) within 4 weeks before screening; (8) Other circumstances (such as pregnant or lactating women) that are considered by the investigator to be unsuitable for participating in this study.

Design outcomes

Primary

MeasureTime frame
Serum albumin;

Secondary

MeasureTime frame
Body mass index;Prealbumin;Grip strength;C-reactive protein;Total lymphocyte count;

Countries

China

Contacts

Public ContactLiyong Chen

Qilu Hospital of Shandong University

chenle73@sina.com+86 185 6008 6487

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026