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| ID | Type | Description | Link |
|---|---|---|---|
| VR3689 | Other Identifier | Vanderbilt |
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Planned parent study never enrolled
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Some Akt inhibitors have produced functional cardiovascular effects such as marked hypotension that may limit their clinical benefit. There are no current data on whether this autonomic failure presents in humans at clinically used doses. We will test the hypothesis that Akt inhibition causes an acute decrease in sympathetic tone and lowers blood pressure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Melanoma | Patients with Melanoma that are enrolled in a clinical trial at the Vanderbilt Ingram Cancer Center (VICC) including an arm with an oral Akt inhibitor |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autonomic Function Tests | Behavioral | Patients will undergo Autonomic Function testing (AFT) before and 8 hours after Akt Inhibition therapy. AFT includes: Supine & standing heart rate & blood pressure, 10 minute head up tilt, cardiac output, sinus arrhythmia, hyperventilation, sustained handgrip, valsalva manuever, and cold pressor test. |
| Measure | Description | Time Frame |
|---|---|---|
| Drop in systolic blood pressure before and after Akt treatment | 8 hours |
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Inclusion Criteria:
Exclusion Criteria:
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Patients will have a diagnosis of Melanoma and be participating in a clinical trial with an arm using oral Akt therapy. Patients will be recruited from the Vanderbilt Ingram Cancer Center.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University | Nashville | Tennessee | 37232 | United States |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| D054970 | Pure Autonomic Failure |
| D007022 | Hypotension |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D016683 | Supine Position |
| ID | Term |
|---|---|
| D011187 | Posture |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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|
| supine and standing catecholamines | Other | patients will have blood drawn from supine and standing catecholamines. |
|
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D054969 | Primary Dysautonomias |
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |