Acute Changes in Endothelial Function in Germ Cell Tumor Patients Treated With Cisplatin and Untreated Germ Cell Tumor Controls

Germ Cell Cancer Clinical Trial

Official title:

A Pilot Study Measuring Acute Changes in Endothelial Function in Germ Cell Tumor Patients Treated With Cisplatin and Untreated Germ Cell Tumor Controls

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01453660
• Other study ID #: 11-140
• Status: Active, not recruiting
• Start date: October 11, 2011
• Est. completion date: October 2024

Study information

• Verified date: November 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 44
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Germ Cell Cancer
• Neoplasms, Germ Cell and Embryonal

Intervention

Other:
• Endo-PAT2000 testing
Endo-PAT2000 testing is done six times during the study. Baseline Assessment Time 1 Cycle 1, Day 1 (Pre-chemotherapy)Time 2 Cycle 1, Day 1 (After 1st dose of cisplatin), Time 3 Cycle 1, Day 2 (Before second cisplatin dose of cycle 1), Time 4 Cycle 1, Day 5 (After last cisplatin dose of cycle 1), End-of-Study Assessment Time 5 (14-34 weeks from Time 1; e.g., 1-12 weeks following completion of the last cycle of first-line chemotherapy) Long-Term Follow Up Assessment Time 6 (24-30 months from Time 1)
• Endo-PAT2000 testing
Time 1: A baseline assessment will be performed in the fasting state including Endo-PAT2000, vital signs, waist circumference, fasting blood draw, & urine sample. This will be considered Day 1 of the study for this group of patients. Time 2 (2-5 hours from Time 1): Two to five hours after Time 1, patients will undergo assessment of blood pressure & heart rate, including orthostatics & Endo-PAT2000 testing. Time 5 -- End of Study visit (14-34 weeks from Time 1): At a time point 14 to 34 weeks later than Time 1 patients will undergo study testing in the fasting state. This includes Endo-PAT2000 testing, vital signs including orthostatics, waist circumference, fasting blood draw, & urine sample. The Surgery-Only Group will not have any assessment at Time 3 (Day 2) or Time 4 (Day 5) due to logistical concerns. Long-Term Follow Up Assessment Time 6 (24-30 months following Time 1)

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure the endothelial reactivity (PAT-RH) in both groups	The Endo-PAT quantifies the endothelium-mediated changes in vascular tone, elicited by a 5-minute occlusion of the brachial artery (using a standard BP cuff).	15 minutes
Secondary	Identify sociodemographic	(age, race/ethnicity)	2 years
Secondary	Identify comorbid health conditions	Other laboratory studies being assessed in this trial will include lipid profile, testosterone, LH, FSH, and hemoglobin A1C. These tests are being evaluated to determine if there are concurrent comorbidities	2 years
Secondary	Measure PAT-RH index	at Time 6 (Long-Term Follow Up Assessment) in the Cisplatin-Based Chemotherapy Group and evaluate long term changes in PATRH index.	2 years

External Links

•   Memorial Sloan Kettering Cancer Center