NCT02442739

Ketamine for Preventing Depression in Patients Undergoing Treatment for Pancreatic or Head and Neck Cancers

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

• Status: Withdrawn
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Cedars-Sinai Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective, single center, double blind, randomized, two-arm feasibility study of oral ketamine versus placebo for the prevention of depression in non-depressed patients with head and neck or pancreatic cancer undergoing curative intent cancer therapy. Approximately 40 patients with head and neck cancer or pancreatic cancer about to undergo cancer therapy will be randomized 1:1 to receive study treatment with one of the following regimens: * Arm A: weekly oral administration of 0.5 mg/kg ketamine * Arm B: weekly oral administration of placebo Consenting patients will undergo screening procedures, and if eligible, a baseline interview and brief questionnaires regarding depression, mental and emotional health, and quality of life assessments. Study treatment will be administered for 12 weeks unless the patient experiences unacceptable toxicities, exhibits moderate to severe depressive symptoms, or withdraws consent. Patients on the placebo treatment arm will not be eligible to cross over to the ketamine arm at evidence of depression but will be removed from the study and treated with standard medical management for depression. Patients will be asked to complete psychosocial measurements every two weeks, before study medication/placebo administration, while on study treatment and monthly during a five-month follow-up period.

Conditions

• Head and Neck Cancer
• Pancreatic Cancer
• Depression

Interventions

Type	Name	Description
DRUG	Ketamine	Ketamine 0.5 mg/kg mixed with syrup will be given by mouth once a week for 12 weeks.
OTHER	Placebo	Placebo syrup will be given by mouth once a week for 12 weeks.

Timeline

• Start date: 2016-08-15
• Primary completion: 2017-11-03
• Completion: 2017-11-03
• First posted: 2015-05-13
• Last updated: 2018-11-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study