A prospective, randomized controlled, single-center Phase II clinical study comparing the effect and safety of intensive nutritional support during periradiotherapy with five-step nutritional support in patients with concurrent chemoradiotherapy for esophageal squamous cell carcinoma

A prospective, randomized controlled, single-center Phase II clinical study comparing the effect and safety of intensive nutritional support during periradiotherapy with five-step nutritional support in patients with concurrent chemoradiotherapy for esophageal squamous cell carcinoma - Intensive nutritional support therapy for esophageal squamous cell carcinoma during periradiotherapy

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300073316

Enrollment

Unknown

Registered

2023-07-06

Start date

2023-07-07

Completion date

Unknown

Last updated

2023-07-10

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

Conditions

Carcinoma of esophagus

Interventions

Observation group:Intensive nutritional support

Control group:five-step nutritional support

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: ? Patients with unresectable locally advanced esophageal squamous cell carcinoma confirmed by pathology in our hospital or confirmed by consultation with pathology obtained from other hospitals; ? All patients signed informed consent; ? The general condition is good, ECOG score =2; ? Age 18-80 years old; (5) The functions of heart, lung, liver, kidney and bone marrow are basically normal, and there are no contraindications of radiotherapy and chemotherapy; ? Can eat a semi-liquid or liquid diet; ? Good patient compliance.

Exclusion criteria

Exclusion criteria: ? Received radiation therapy or chemotherapy in the past; ? Previous or concurrent with other malignant tumors; ? Severe impairment of intestinal function or intolerance of enteral nutrition; (4) Serious medical disease or infection; ? Major organ failure; ? Mental abnormalities, serious cognitive impairment and inability to cooperate.

Design outcomes

Primary

Measure	Time frame
Anti-tumor short-term efficacy(ORR);	—

Secondary

Measure	Time frame
Nutritional status index(Body weight, hemoglobin, serum albumin, lymphocytes, PG-SGA score);Therapeutic side effects (incidence of 3 degrees and above myelosuppression, 3 degrees and above radiation esophagitis, 3 degrees and above radiation pneumonia);Quality of life score(QLQ-C30);Survival situation(PFS);	—

Countries

China

Contacts

Public ContactFanjun Meng

Jieyang People's Hospital

1220561512@qq.com+86 139 0275 2590

Outcome results

None listed

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