Monitoring Radiation Induced Cardiac Damage by Blood Markers

Completed

• Conditions: Radiation Induced Cardiac Damage

• Registration Number: NCT02481778
• Lead Sponsor: University Medical Center Groningen

Brief Summary

Rationale:

Radiation induced cardiac toxicity after treatment for intrathoracic tumours is a clinically relevant problem. So far, no clinical prediction models exist for cardiac toxicity. In particular, the relationship between radiation dose parameters and the risk of cardiac toxicity remains to be determined.

Clinical prediction models for cardiac toxicity are difficult to obtain, e.g. due to long latency time. Therefore, objective surrogate markers, for cardiac toxicity such as NT pro BNP and hs-TNT, as obtained during and after treatment may be of great value.

Objective:

The main objective to find a correlation between the rise in NT pro BNP level and the radiation dose given to the heart.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-05-11
• Study First Submitted QC: 2015-06-22
• Study First Posted: 2015-06-25
• Study Start: 2015-09-08
• Primary Completion: 2020-08
• Study Completion: 2020-08
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-26
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

• Histologically proven oesophageal- or lung cancer (adeno-, or squamous cell carcinoma or other NSCLC type)
• Older than 18 years
• Written informed consent

Exclusion Criteria

• Prior radiotherapy to the chest including radiotherapy for breast cancer
• Patients treated with palliative intent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in percentage of rise of the level of NT pro BNP after radiotherapy	At 1 year after end of radiation therapy

Secondary Outcome Measures

Name	Time	Method
Change in percentage of rise of hs-TNT during or after treatment	At day 1 start radiation therapy and at last day of radiation therapy (an expected average of 5 weeks after start of radiation therapy) and at 4 weeks, 6 months, 1 and 2 years after end of radiation therapy.
Cardiac events	After start treatment up to 2 years after end of radiation therapy.	A new diagnosis of: heart failure, myocardial infarction or a newly diagnosed rhythm disorder will be scored as a cardiac event. Myocardial ischaemia requiring intervention and changes in cardiac medication in case of deterioration of known heart failure will be analysed by a cardiologist to decide whether or not to score this as an event. Events will be scored according the CTCAE 4.2 criteria.

Trial Locations

Locations (1)

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands