Influence of Different Light Dose on the Adverse Effect of Swallowing for Esophageal Carcinoma

Not Applicable

• Conditions: Esophagus Cancer
• Interventions: Combination Product: single irradiation; Combination Product: Double irradiation

• Registration Number: NCT05174117
• Lead Sponsor: The First Affiliated Hospital of Henan University of Science and Technology

Brief Summary

The purpose of this experiment is to study the alleviating effects and side effects of different laser irradiation doses on esophageal stricture of esophageal cancer in order to find the appropriate dose of light.

Detailed Description

Background: Photodynamic therapy (PDT) is one of the effective means for the control of esophageal stenosis in advanced esophageal cancer, among which the dose intensity of laser irradiation is one of the factors affecting the efficacy. This study aims to pursue the appropriate dose of light.

Aim: To compare the efficacy and safety of two groups of different laser irradiation doses for advanced esophageal cancer and esophageal stricture.

Methods: Fifty-seven patients were recruited for this study and randomly divided into two groups: single irradiation group and reirradiation group.Single irradiation group: 46-48h irradiation after photosensitizer injection: power density: 200mW·cm-2, irradiation time: 900s, volume density: 180 J·cm-2;Double irradiation group: 46-48h, 72h after photosensitizer injection, divided into two irradiation times: power density: 200mW·cm-2, irradiation time: 900s, volume density: 180 J·cm-2;Power density: 200mW·cm-2, irradiation time: 300s, volume density: 60 J·cm-2.

Primary endpoints: ORR rates at 1 and 3 months, the quality of life

Study Timeline

• Status Verified: 2021-12
• Study First Submitted: 2021-12-21
• Study First Submitted QC: 2021-12-29
• Last Update Submitted: 2021-12-29
• Study First Posted: 2021-12-30
• Last Update Posted: 2021-12-30
• Study Start: 2022-01-01
• Primary Completion: 2022-12-31
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

• esophagus cancer
• 18-80 years old
• grade 3-4 dysphagia （Stoller classification）
• Non-eradicative second-line treatment

Exclusion Criteria

• Ulcerative tumor
• Esophageal stenosis caused by radiotherapy
• Survival is less than 3 months
• Patients known to be allergic to photosensitizers

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
single irradiation group	single irradiation	46-48h irradiation after photosensitizer injection: power density: 200mW·cm-2, irradiation time: 900s, volume density: 180 J·cm-2
Double irradiation group	Double irradiation	46-48h, 72h after photosensitizer injection, divided into two irradiation times: power density: 200mW·cm-2, irradiation time: 900s, volume density: 180 J·cm-2;Power density: 200mW·cm-2, irradiation time: 300s, volume density: 60 J·cm-2.

Primary Outcome Measures

Name	Time	Method
1 month objective response rate	1 month after photodynamic irradiation	Grade 3-4 dysphagia accounted
3 month objective response rate	3 month after photodynamic irradiation	Grade 3-4 dysphagia accounted

Secondary Outcome Measures

Name	Time	Method
3 month Quality of Life score	3 month after photodynamic irradiation

Trial Locations

Locations (1)

The First Affiliated Hospital and Clinical Medicine of Henan University of Science and Technology; 🇨🇳 Luoyang, Henan, China