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Early Specialized Cardiovascular Intervention Based on Impedance Cardiography in Locally Advanced Non-small Cell Lung Cancer Patients

Primary Purpose

Non-small Cell Lung Cancer, Cardiovascular Complication

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Multiple cardiovascular drugs related to "Golden Triangle"
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring Non-small Cell Lung Cancer, Cardiovascular Intervention, Impedance Cardiography, Cardiovascular Event

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. It is diagnosed as non-small cell lung cancer by pathological examination or cytological examination; it is assessed as locally advanced, unresectable stage III non-small cell lung cancer by imaging;
  2. Plan to receive radical radiotherapy and chemotherapy ± immunotherapy;
  3. Male or female between 18 and 75 years old;
  4. Life expectancy ≥ 12 weeks;
  5. The World Health Organization (WHO) PS score is 0 or 1;
  6. Organ and bone marrow function meet the following conditions: Forced expiratory volume per second (FEV1) ≥1000 ml; absolute neutrophil count ≥1.5×10^9/L; platelets ≥100×10^9/L; hemoglobin ≥90 g/L ; Serum creatinine clearance calculated according to the Cockcroft-Gault formula ≥50 mL/min (Cockcroft and Gault 1976); serum bilirubin ≤1.5 times the upper limit of normal (ULN); alanine aminotransferase and aspartate aminotransferase ≤2.5 times ULN;
  7. A signed informed consent form is required before proceeding with any step in the research;
  8. There is an abnormality in the initial cardiac output index.

Exclusion Criteria:

  1. PS score 2-4;
  2. Organ function impairment: FEV1 <1000ml; absolute neutrophil count <1.5×10^9/L; platelets <100×10^9/L; hemoglobin <90 g/ L; Serum creatinine clearance calculated according to Cockcroft-Gault formula <50 mL/min; serum bilirubin>1.5 times ULN; alanine aminotransferase and aspartate aminotransferase>2.5 times ULN;
  3. Unstable angina or myocardial infarction occurred in the past month;
  4. Arrhythmia that has not been controlled and can cause symptoms or abnormal hemodynamics;
  5. Active endocarditis;
  6. Symptomatic severe aortic stenosis;
  7. Heart failure that has not been controlled;
  8. Acute pulmonary embolism, pulmonary infarction or low thrombosis (artery or vein) formation;
  9. Suspected or confirmed aortic dissection;
  10. Uncontrolled bronchial asthma;
  11. Pulmonary edema;
  12. Fingertip blood oxygen saturation at rest ≤85%;
  13. Acute non-cardiopulmonary diseases (such as infection, renal failure, thyrotoxicosis, etc.) that may affect sports performance or aggravate due to exercise;
  14. Mental disorders make it impossible to cooperate.

Sites / Locations

  • Sun yat-sen University Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

The early intervention group

The control group

Arm Description

The early intervention group: evaluation and intervention based on impedance cardiography results at multiple timepoints. Specific intervention measures include: cardiovascular drug treatment: based on the increase and decrease of the "Golden Triangle" ACEI, perindopril tert-butyrate 4mg qd β receptor antagonist, metoprolol succinate 47.5mg qd Spironolactone 20mg qd Drugs to improve myocardial metabolism: trimetazidine hydrochloride 35 mg bid Other therapeutic drugs include: loop diuretics, ARNI, sinus node If current selection specific inhibitors, statins, antiplatelet aggregation and nitrate drugs, etc. Exercise intervention: exercise prescription based on the initial cardiopulmonary exercise test results.

This group will be under observation. When cardiovascular events (including ischemic cardiomyopathy, heart failure, arrhythmia requiring treatment, pericardial disease requiring treatment, valvular disease, etc.) happen, a cardiovascular specialist assessment and intervention will be given.

Outcomes

Primary Outcome Measures

Overall survival
It was calculated from the first day of treatment to the day of death.

Secondary Outcome Measures

Cumulative incidence of cardiotoxicity events
Cumulative incidence of ≥ Grade 3 cardiotoxicity events
Progression-free survival
From the first day of treatment to the day of progression or the day of death.

Full Information

First Posted
July 24, 2021
Last Updated
October 25, 2022
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT04980716
Brief Title
Early Specialized Cardiovascular Intervention Based on Impedance Cardiography in Locally Advanced Non-small Cell Lung Cancer Patients
Official Title
Early Specialized Cardiovascular Intervention Based on Impedance Cardiography in Locally Advanced Non-small Cell Lung Cancer Patients Who Receiving Radical Concurrent Chemoradiotherapy and Immunotherapy: a Prospective, Randomized Controlled, Multicenter Phase III Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
January 31, 2026 (Anticipated)
Study Completion Date
July 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This is a prospective, randomized, controlled, multi-center phase III clinical trial that intends to evaluate the role of early cardiovascular intervention based on impedance cardiography in patients with locally advanced non-small cell lung cancer receiving radical radiochemotherapy±immunotherapy.
Detailed Description
This is a prospective, randomized, controlled, multi-center phase III clinical trial that intends to evaluate the role of early cardiovascular intervention based on impedance cardiography in patients with locally advanced non-small cell lung cancer receiving radical radiochemotherapy±immunotherapy. The participants were 1:1 randomized to the intervention group and the control group. The intervention group will receive cardiovascular evaluation and intervention at multiple timepoints throughout treatment and follow-up, while the control group will be under observation unless severe cardiovascular events happen. The evaluation and intervention timepoints include: Before neoadjuvant therapy (no intervention time point for those who do not receive neoadjuvant therapy), before the first course of radiotherapy, 3-4 weeks after the first course of radiotherapy, 2 months after the second course of radiotherapy, 8 months after the second course of radiotherapy, 14 months after the second course of radiotherapy .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer, Cardiovascular Complication
Keywords
Non-small Cell Lung Cancer, Cardiovascular Intervention, Impedance Cardiography, Cardiovascular Event

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
524 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
The early intervention group
Arm Type
Experimental
Arm Description
The early intervention group: evaluation and intervention based on impedance cardiography results at multiple timepoints. Specific intervention measures include: cardiovascular drug treatment: based on the increase and decrease of the "Golden Triangle" ACEI, perindopril tert-butyrate 4mg qd β receptor antagonist, metoprolol succinate 47.5mg qd Spironolactone 20mg qd Drugs to improve myocardial metabolism: trimetazidine hydrochloride 35 mg bid Other therapeutic drugs include: loop diuretics, ARNI, sinus node If current selection specific inhibitors, statins, antiplatelet aggregation and nitrate drugs, etc. Exercise intervention: exercise prescription based on the initial cardiopulmonary exercise test results.
Arm Title
The control group
Arm Type
No Intervention
Arm Description
This group will be under observation. When cardiovascular events (including ischemic cardiomyopathy, heart failure, arrhythmia requiring treatment, pericardial disease requiring treatment, valvular disease, etc.) happen, a cardiovascular specialist assessment and intervention will be given.
Intervention Type
Drug
Intervention Name(s)
Multiple cardiovascular drugs related to "Golden Triangle"
Intervention Description
Based on impedance cardiography results at each timepoints, cardiovascular drug treatment and exercise plan will be given in the intervention group.
Primary Outcome Measure Information:
Title
Overall survival
Description
It was calculated from the first day of treatment to the day of death.
Time Frame
2-year
Secondary Outcome Measure Information:
Title
Cumulative incidence of cardiotoxicity events
Description
Cumulative incidence of ≥ Grade 3 cardiotoxicity events
Time Frame
2-year
Title
Progression-free survival
Description
From the first day of treatment to the day of progression or the day of death.
Time Frame
2-year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: It is diagnosed as non-small cell lung cancer by pathological examination or cytological examination; it is assessed as locally advanced, unresectable stage III non-small cell lung cancer by imaging; Plan to receive radical radiotherapy and chemotherapy ± immunotherapy; Male or female between 18 and 75 years old; Life expectancy ≥ 12 weeks; The World Health Organization (WHO) PS score is 0 or 1; Organ and bone marrow function meet the following conditions: Forced expiratory volume per second (FEV1) ≥1000 ml; absolute neutrophil count ≥1.5×10^9/L; platelets ≥100×10^9/L; hemoglobin ≥90 g/L ; Serum creatinine clearance calculated according to the Cockcroft-Gault formula ≥50 mL/min (Cockcroft and Gault 1976); serum bilirubin ≤1.5 times the upper limit of normal (ULN); alanine aminotransferase and aspartate aminotransferase ≤2.5 times ULN; A signed informed consent form is required before proceeding with any step in the research; There is an abnormality in the initial cardiac output index. Exclusion Criteria: PS score 2-4; Organ function impairment: FEV1 <1000ml; absolute neutrophil count <1.5×10^9/L; platelets <100×10^9/L; hemoglobin <90 g/ L; Serum creatinine clearance calculated according to Cockcroft-Gault formula <50 mL/min; serum bilirubin>1.5 times ULN; alanine aminotransferase and aspartate aminotransferase>2.5 times ULN; Unstable angina or myocardial infarction occurred in the past month; Arrhythmia that has not been controlled and can cause symptoms or abnormal hemodynamics; Active endocarditis; Symptomatic severe aortic stenosis; Heart failure that has not been controlled; Acute pulmonary embolism, pulmonary infarction or low thrombosis (artery or vein) formation; Suspected or confirmed aortic dissection; Uncontrolled bronchial asthma; Pulmonary edema; Fingertip blood oxygen saturation at rest ≤85%; Acute non-cardiopulmonary diseases (such as infection, renal failure, thyrotoxicosis, etc.) that may affect sports performance or aggravate due to exercise; Mental disorders make it impossible to cooperate.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bo Qiu
Phone
+862087343031
Email
qiubo@sysucc.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hui Liu, Professor
Organizational Affiliation
Sun yat-sen universtiy cancer center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bo Qiu, Professor
Phone
+862087343031

12. IPD Sharing Statement

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Early Specialized Cardiovascular Intervention Based on Impedance Cardiography in Locally Advanced Non-small Cell Lung Cancer Patients

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