Autonomic Phenotype Before and After Akt Inhibition

NCT01593579 | Withdrawn

• 2 other identifiers: 120390VR3689
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diagnosis of Melanoma

Keywords

melanoma; autonomic failure; hypotension; akt therapy

Outcome Measures

Primary Outcomes (1)

• Drop in systolic blood pressure before and after Akt treatment

  8 hours

Study Arms (1)

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

Behavioral: Autonomic Function Tests; Other: supine and standing catecholamines

Interventions

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.

Patients with Melanoma

supine and standing catecholamines OTHER

patients will have blood drawn from supine and standing catecholamines.

Patients with Melanoma

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• Diagnosed with melanoma with a BRAF mutation and relapse following therapy with a BRAF inhibitor
• Enrolled in a clinical trial through the Vanderbilt Ingram Cancer Center (VICC) including an arm with an oral Akt inhibitor
• Able and willing to provide informed consent

You may not qualify if:

• Factors which in the investigator's opinion would prevent the participant from completing the protocol, including poor compliance during previous studies or an unpredictable schedule
• Unable to give informed consent

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Melanoma; Pure Autonomic Failure; Hypotension

Interventions

Supine Position

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 4, 2012
• First Posted: May 8, 2012
• Study Start: May 1, 2012
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2016
• Last Updated: December 23, 2014

Record last verified: 2014-12

Locations

US (1)