Acute Changes in Endothelial Function in Germ Cell Tumor Patients Treated With Cisplatin and Untreated Germ Cell Tumor Controls
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/4/2018 |
| Start Date: | October 11, 2011 |
| End Date: | October 2019 |
A Pilot Study Measuring Acute Changes in Endothelial Function in Germ Cell Tumor Patients Treated With Cisplatin and Untreated Germ Cell Tumor Controls
Cisplatin is one of the most common chemotherapy drugs used to treat many different cancers,
including germ cell tumors (GCT). Cisplatin is very effective in treating GCT, but there are
side effects. One of the possible long-term side effects of cisplatin is thought to be heart
disease. The way that cisplatin causes heart disease is not well understood. One possibility
is that cisplatin may damage the inside layer of blood vessels called the endothelium. The
purpose of this study is to measure changes in the endothelium that happen when patients with
GCT get cisplatin chemotherapy and to compare these changes with a group of patients not
receiving chemotherapy.
including germ cell tumors (GCT). Cisplatin is very effective in treating GCT, but there are
side effects. One of the possible long-term side effects of cisplatin is thought to be heart
disease. The way that cisplatin causes heart disease is not well understood. One possibility
is that cisplatin may damage the inside layer of blood vessels called the endothelium. The
purpose of this study is to measure changes in the endothelium that happen when patients with
GCT get cisplatin chemotherapy and to compare these changes with a group of patients not
receiving chemotherapy.
Inclusion Criteria:
Cisplatin-Based Chemotherapy Group
- Histologically-proven diagnosis of GCT
- Male
- Age ≥18
- No prior exposure to chemotherapy or radiation
- Planned to receive 3-4 cycles of cisplatin-based chemotherapy
Surgery-Only Group
- Histologically-proven diagnosis of GCT Male
- Age ≥18
- Surgical management of GCT performed less than 90 days before start of study (includes
orchiectomy and primary retroperitoneal lymph node dissection (RPLND))
- No prior exposure to chemotherapy or radiation
Exclusion Criteria:
Cisplatin-Based Chemotherapy Group
- Prior exposure to chemotherapy or radiation
- Known diagnosis or history of being diagnosed with vasculitis, autonomic dysfunction,
coronary artery disease, or collagen-vascular disease
Surgery-Only Group
- Prior exposure to chemotherapy or radiation
- Planned for non-surgical management with chemotherapy or radiation.
- Known diagnosis or history of being diagnosed with vasculitis, autonomic dysfunction,
coronary artery disease, or collagen-vascular disease.
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