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WithdrawnEarly Phase 1

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

NCT02442739 · Cedars-Sinai Medical Center

Closed to entry
Status
Not accepting participants
Early Phase 1
Phase
Target enrolment
1
Study sites
1 US states

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Proportion of patients pre-screened that were potentially eligible for study participation.

    Measured over 36 months

  • Proportion of patients that were potentially eligible who were approached.

    Measured over 36 months

  • Proportion of approached patients that decline study participation and why.

    Measured over 36 months

  • Proportion of approached patients that agreed to participate.

    Measured over 36 months

  • Proportion of approached that were randomized.

    Measured over 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.

    Measured over 36 months

  • Proportion of patients that are evaluable

    Measured over 36 months

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: 1. Ability to understand and the willingness to sign a written informed consent. 2. Stage -II-IV epidermoid cancer of the head and neck OR stage III-IV pancreatic cancer, with prognosis of at least three months, per oncologist. 3. Within two weeks of starting or from having started, curative intent therapy for head and neck cancer. 4. Age ≥ 18 years. 5. Adequate liver function as defined by: * ALT \< 5 X institutional upper limit of normal (ULN) * AST \< 5 X institutional ULN * Total bilirubin \< 5 X institutional ULN 6. Both men and women of all races and ethnic groups are eligible for this trial. 7. Use of antidepressants is permitted if dose has been the same for at least 12 weeks prior to study entry if patient still DOES NOT meet exclusion criteria #3. 8. Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform the study team and her treating physician immediately. Urine pregnancy testing will be done throughout the trial for women of childbearing potential. 9. Must read and understand English fluently. Exclusion Criteria: 1. Receiving another investigational agent on a clinical trial that prohibits participation in other studies of investigational agents. 2. Meets Mini International Neuropsychiatric interview (MINI) criteria for major depression, schizophrenia, bipolar illness, delirium or psychosis. 3. Has moderate to severe depression according to both the Quick Inventory of Depressive Symptomatology-Self Rated 16 (QIDS-SR-16) score of ≥ 11 AND a Hospital Anxiety and Depression Scale (HADS) Depression subscale score of ≥ 8. 4. Has Suicidal Risk Assessment (SRA) scores ≥ 6. 5. Use of monoamine oxidase inhibitors within 14 days of study entry. 6. Diagnosed with melanoma or lymphoma cancer of the head and neck. 7. Diagnosed with Stage I or II pancreatic cancer or with anticipated survival of less than three months. 8. History of allergic reactions or hypersensitivity to ketamine. 9. Severe cardiac insufficiency (NYHA III or IV), with uncontrolled and/or unstable cardiac or coronary artery disease. 10. History of significant tachyarrhythmia, severe angina, or myocardial ischemia 11. Poorly controlled hypertension (Systolic Blood Pressure \> 180 mmHG or Diastolic Blood Pressure \> 100 mmHG), with or without antihypertensives. 12. If a woman is or becomes pregnant or is nursing at any time before or during the treatment period, she will be excluded from the study. 13. Score of ≥ 8 on the WHO Alcohol Use Disorders Identification Test (AUDIT, sensitivity of 0.8).

Where

1 study site

FacilityCityRegionCountry
Cedars-Sinai Medical CenterLos AngelesCaliforniaUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT02442739 on ClinicalTrials.gov →

Last updated in the registry 2018-11-06. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits