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

NCT ID: NCT04530097

Last Updated: 2020-08-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2022-09-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

RFA+MLT

Radiofrequency ablation was performed immediately after enrollment, and melatonin treatment was given for 6 months after 1 week after radiofrequency.

Group Type: EXPERIMENTAL

RFA

Intervention Type: PROCEDURE

Radiofrequency ablation was performed immediately after enrollment, and melatonin treatment was given for 6 months after 1 week after radiofrequency.

RFA

Radiofrequency ablation was performed immediately after enrollment, and a placebo treatment program was given for 6 months after 1 week after radiofrequency.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

RFA

Radiofrequency ablation was performed immediately after enrollment, and melatonin treatment was given for 6 months after 1 week after radiofrequency.

Intervention Type: PROCEDURE

Other Intervention Names

MLT

Eligibility Criteria

Inclusion Criteria

• (1) Patients can understand and voluntarily join this study, sign an informed consent form, and have good compliance.

(2) Patients with peripheral early lung cancer who cannot tolerate surgery with poor cardiopulmonary function; (3) Patients with peripheral early-stage lung cancer who cannot tolerate surgery; (4) Patients with peripheral early lung cancer who are unwilling to undergo surgery; (5) The tumor is more than 1.0 cm away from large blood vessels or larger bronchi.

(6) Age ≥18 years old and ≤85 years old; (7) ECOG PS score: 0-2 points; (8) Good coagulation function, platelet count ≥100×10^9/L, INR and PT≤1.5 times ULN; if the subject is receiving anticoagulation therapy, as long as the PT is within the intended use range of anticoagulation drugs; (9) Females of childbearing age should agree to use contraceptive measures (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months after the end of the study; serum or urine pregnancy test within 7 days before study entry Negative, and must be a non-lactating patient; men should agree to patients who must use contraception during the study period and within 6 months after the end of the study period.

Exclusion Criteria

• (1) Those with severe comorbidities, infection period, and immunocompromised persons; (2) Patients who are judged to seriously affect survival or cannot tolerate thoracoscopic surgery in pre-assessment; (3) Patients who have contraindications to radiofrequency ablation and cannot complete the treatment; (4) Merge other organ/system tumors. (5) At present, patients with long-term oral hormones and autoimmune diseases (6) Various bleeding diseases, acute infectious diseases, fever, women during pregnancy, (7) Recovery period after heart surgery or stent implantation. (8) Those who are difficult to cooperate to complete the baseline test; those who cannot take drugs regularly;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shanghai 10th People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ming Li

Associate senior doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shanghai 10th People's Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Facility Contacts

Li Ming, M.D.

Role: primary

mlid163@163.com

13391358760

Other Identifiers

2020KT128

Identifier Type: -

Identifier Source: org_study_id