An Early Phase 1 interventional study of Ketamine and Placebo in Head and Neck Cancer, Pancreatic Cancer and Depression, sponsored by Cedars-Sinai Medical Center. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-11-06.
Sponsored by Cedars-Sinai Medical Center · Early Phase 1, Interventional, and Prevention
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.
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:
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.
2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.
Browse Head and Neck Neoplasms studies →Cedars-Sinai Medical Center is the lead sponsor of 442 studies on the registry; 109 are open to participants now.
Of its 62 completed or terminated interventional studies of FDA-regulated products, 47 (76%) have results posted.
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Adequate liver function as defined by:
Exclusion Criteria:
oral ketamine 0.5 mg/kg mixed with syrup
Drug: Ketamine
oral placebo (syrup)
Other: Placebo
Ketamine 0.5 mg/kg mixed with syrup will be given by mouth once a week for 12 weeks.
Also known as: Ketalar
Placebo syrup will be given by mouth once a week for 12 weeks.
Proportion of patients pre-screened that were potentially eligible for study participation.
Time frame: 36 months
Proportion of patients that were potentially eligible who were approached.
Time frame: 36 months
Proportion of approached patients that decline study participation and why.
Time frame: 36 months
Proportion of approached patients that agreed to participate.
Time frame: 36 months
Proportion of approached that were randomized.
Time frame: 36 months
Proportion of patients discontinuing prematurely from study treatment for any reason, including side effects attributed to ketamine or side effects attributed to placebo, documenting reasons for dropout.
Time frame: 36 months
Proportion of patients that are evaluable
Subjects with a baseline and one post-baseline visit are evaluable and will be included in the analyses.
Time frame: 36 months
Treatment-related adverse events
Adverse Events rated as possibly/probably related to study treatment
Time frame: 4 months
Patient-reported tolerability questionnaire (FIBSER)
Time frame: 4 months
Treatment expectancy and satisfaction as measured by the credibility/expectancy questionnaire (CEQ).
Time frame: 4 months
Incidence of new onset mild, moderate, or severe depressive symptoms as assessed by questionnaire (QIDS-SR-16)
Time frame: 4 months
Depression-free survival
Time frame: 4 months
Severity of cancer-related pain as assessed by a visual analog scale (VAS)
Time frame: 4 months
Anxiety and depressive symptoms as assessed by questionnaire (HADS)
Time frame: 4 months
Quality of life as assessed by questionnaire (UW-QOL)
Time frame: 4 months
Suicide risk and ideation as assessed by questionnaire (SRA)
Time frame: 4 months
This study is withdrawn, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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Cedars-Sinai Medical Center