NCT04530097

Radiofrequency Ablation Combined With Melatonin in the Treatment of Stage IA NSCLC

A Prospective, Double-blind, Randomized Controlled Study of Radiofrequency Ablation Combined With Melatonin in the Treatment of Stage IA NSCLC

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 260 (estimated)
• Sponsor: Shanghai 10th People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

Based on the recommendations of the guidelines, as well as the previous animal studies and clinical studies of our team, we designed and carried out prospective, randomized controlled, double-blind clinical studies to further expand the sample size to verify the efficacy of radiofrequency ablation combined with melatonin in the treatment of stage IA NSCLC. It is hoped that this combined treatment plan can delay the recurrence of lung cancer after RFA and prolong the survival time of patients.

Detailed description

OBJECTIVES: To verify the efficacy of radiofrequency ablation combined with melatonin in the treatment of stage IA non-small cell lung cancer, and explore new directions for the prevention and treatment of early stage non-small cell lung cancer. OUTLINE: This is a Prospective, double-blind, randomized controlled study. Using the same admission criteria, it is planned to enroll 260 patients, who will be randomly assigned 1:1. The experimental group: radiofrequency ablation combined with melatonin, and the control group: radiofrequency ablation combined with placebo. Intervention group: Radiofrequency ablation was performed immediately after enrollment, and melatonin treatment was given for 6 months after 1 week after radiofrequency. Control group: Radiofrequency ablation was performed immediately after enrollment, and a placebo treatment program was given for 6 months after 1 week after radiofrequency.

Conditions

• NSCLC and Theropy

Interventions

Type	Name	Description
PROCEDURE	RFA	Radiofrequency ablation was performed immediately after enrollment, and melatonin treatment was given for 6 months after 1 week after radiofrequency.

Timeline

• Start date: 2021-01-01
• Primary completion: 2022-09-30
• Completion: 2022-09-30
• First posted: 2020-08-28
• Last updated: 2020-08-28

Locations

1 site across 1 country: China