Investigating Cardiovascular Adverse Events Related to Cancer Treatment

Launched by UNIVERSITY MEDICAL CENTER GRONINGEN · Jun 22, 2017

Keywords

ClinConnect Summary

This clinical trial is studying the severe heart and lung problems that can occur in some patients after receiving certain cancer treatments, specifically drugs like cisplatin, anthracyclines, bleomycin, and trastuzumab. Researchers want to understand why some people experience extreme side effects while others do not. By examining cells derived from patients, they hope to learn more about these serious reactions and potentially identify the long-term heart issues that many cancer survivors may face.

To be eligible for this study, participants should be between 18 and 50 years old and have been treated for cancer with the intent to cure it. They also need to have experienced severe side effects from one of the mentioned treatments, but must have completed their cancer treatment and be free from severe toxicity for a certain period afterward. If you join the study, you can expect to undergo some tests and possibly a skin biopsy, which is a small procedure to collect skin samples. This research is vital as it may help improve future cancer treatments and better protect patients' heart health.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• In order to be eligible to participate in this study, a subject must meet all of these criteria:
• • 1. any proven cancer treated with curative intent;
• • 2. age ≥ 18 and ≤ 50 years;
• • 3. able to comply with the protocol;
• • 4. signed written informed consent.
• There are specific inclusion criteria for every subject group:
• • severe toxicity during 1 to 3 cycles of anthracyclines;
• • ≥ 3 months after end of cancer treatment which included the maximum tolerable dose of anthracyclines without (severe) toxicity;
• • severe toxicity within 1 to 6 cycles of trastuzumab;
• • ≥ 3 months after end of cancer treatment which included a year of trastuzumab without (severe) toxicity.
• • severe toxicity during 1 to 3 cycles of cisplatin;
• • ≥ 1 year after end of cancer treatment which included high-dose cisplatin without toxicity;
• • severe toxicity during 1 to 3 cycles of bleomycin;
• • ≥ 1 year after end of cancer treatment which included high-dose bleomycin without toxicity.
• • Severe toxicity is defined as any of grade 3 - 4 toxicity according to CTCAE 4.03.
• A potential subject who meets any of the following exclusion criteria will be excluded from participation in this study:
• • 1. history of cardiovascular disease prior to start of cancer treatment, as evidenced by any of the following: symptomatic or treated cardiovascular disease prior to start of cancer treatment; LVEF \< 55% at any performed MUGA scan or echocardiography prior to start of cancer treatment;
• • 2. any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol, or insufficient understanding of the Dutch language;
• • 3. any contraindication for skin biopsy, including: extensive skin disorder precluding biopsy of unaffected skin; known allergy to local anaesthetics; use of anticoagulants and INR \> 3;
• • 4. pregnant or lactating female.
• Furthermore, there are specific exclusion criteria for the control groups:
• • 5. history of cardiovascular disease during or after cancer treatment, as evidenced by any of the following: any symptomatic or treated cardiovascular disease; LVEF \< 55% at any performed MUGA scan or echocardiography.