Ketamine molecule:

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Ketamine Clinical Trials

A Randomized, Double Blind, Feasibility Study of Oral Ketamine Versus Placebo for Prevention of Depression in Patients Undergoing Treatment for Pancreatic or Head and Neck Cancers

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Id: NCT02442739

Organisation Name: Cedars-Sinai Medical Center

Overal Status: Withdrawn

Start Date: August 15, 2016

Last Update: November 6, 2018

Lead Sponsor: Cedars-Sinai Medical Center

Brief Summary: The primary purpose of this study is to see if it is safe to give patients with pancreatic or head and neck cancer a low dose of the FDA approved anesthetic drug ketamine at the same time they receive radiation and/or chemotherapy for their cancer treatment to prevent depression and its effects. Researchers would also like to see if giving ketamine at the same time as cancer treatment is practical and reasonably acceptable to the patient.

New onset depression is highly frequent in those with head and neck cancer, and depression has many negative consequences for outcomes in those patients. Depression has been known to have greater incidence in pancreatic cancer patients than in patients with other malignancies.

Therefore, investigators would also like to see if giving patients ketamine during their routine cancer treatment will prevent the onset of depression and its negative effects on cancer treatment outcomes, and also help with anxiety, pain, and quality of life. The study will also use a placebo to compare to the good and/or bad effects of ketamine. A placebo is not an active drug and it will be look the same as ketamine, as a liquid to be taken by mouth.

Ketamine is approved by the U.S. Food and Drug Administration (FDA) as a general anesthetic by itself for some diagnostic and surgical procedures or combined with other general anesthetic agents. It has also been shown to reduce cancer pain. Ketamine is considered experimental in this study because it is not approved by the FDA for the prevention of depression.

  • Head and Neck Cancer
  • Pancreatic Cancer
  • Depression

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