Feasibility study of prophylactic nutritional support therapy versus conventional nutritional therapy in patients with head, neck and digestive tract malignant tumors treated with radiotherapy

Efficacy and safety of prophylactic nutritional support versus conventional nutritional therapy in patients with radiotherapy for head, neck and digestive tract malignancies: a prospective, multicenter, phase 3, parallel, randomized, controlled study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200055410

Enrollment

Unknown

Registered

2022-01-08

Start date

2022-01-10

Completion date

Unknown

Last updated

2023-01-30

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

Conditions

Malignant tumor

Interventions

Experimental group:preventive nutritional support

Control group:none

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. All patients were pathologically diagnosed with malignant tumors of the head and neck or digestive tract; 2. All patients with radiotherapy or concurrent radiotherapy and chemotherapy; 3. ECOG score 0-2 points; 4. Complete clinical data: age, gender, ECOG score, height, weight, CRP, biochemistry and blood routine, etc.; 5. During radiotherapy and chemotherapy, blood routine and biochemical test results every 2 weeks; 6. Complete tumor follow-up results every 3 months after the end of chemoradiotherapy or according to the patient's condition.

Exclusion criteria

Exclusion criteria: 1. Patients with mental disorders; 2. Patients with severe cardiopulmonary dysfunction; 3. Coexist with other malignant tumors.

Design outcomes

Primary

Measure	Time frame
ECOG score;Blood biochemistry;Body mass index;Blood routine;Inflammatory biomarkers;The quality of life;RTOG acute radiation injury classification;Whether radiotherapy is interrupted;Hospitalization days;Overall survival;	—

Countries

China

Contacts

Public ContactZhang Junli

Arlen998@126.com+86 13586260906

Outcome results

None listed

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