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

NCT02442739 | Withdrawn Early Phase 1 DMC FDA Drug

• 2 other identifiers: IIT2015-22-IRWIN-KETPREVE1R21CA197023-01A1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer; Pancreatic Cancer; Depression

Keywords

Ketamine; Prevention of depression

Outcome Measures

Primary Outcomes (7)

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

  36 months

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

  36 months

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

  36 months

• Proportion of approached patients that agreed to participate.

  36 months

• Proportion of approached that were randomized.

  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.

  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.

  36 months

Secondary Outcomes (3)

• Treatment-related adverse events

  4 months

• Patient-reported tolerability questionnaire (FIBSER)

  4 months

• Treatment expectancy and satisfaction as measured by the credibility/expectancy questionnaire (CEQ).

  4 months

Other Outcomes (6)

• Incidence of new onset mild, moderate, or severe depressive symptoms as assessed by questionnaire (QIDS-SR-16)

  4 months

• Depression-free survival

  4 months

• Severity of cancer-related pain as assessed by a visual analog scale (VAS)

  4 months

Study Arms (2)

Ketamine

EXPERIMENTAL

oral ketamine 0.5 mg/kg mixed with syrup

Drug: Ketamine

Placebo

PLACEBO COMPARATOR

oral placebo (syrup)

Other: Placebo

Interventions

Ketamine DRUG

Ketamine 0.5 mg/kg mixed with syrup will be given by mouth once a week for 12 weeks.

Also known as: Ketalar

Ketamine

Placebo OTHER

Placebo syrup will be given by mouth once a week for 12 weeks.

Placebo

Eligibility Criteria

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

You may qualify if:

• Ability to understand and the willingness to sign a written informed consent.
• 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.
• Within two weeks of starting or from having started, curative intent therapy for head and neck cancer.
• Age ≥ 18 years.
• 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
• Both men and women of all races and ethnic groups are eligible for this trial.

You may not qualify if:

• 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.
• Must read and understand English fluently.
• Receiving another investigational agent on a clinical trial that prohibits participation in other studies of investigational agents.
• Meets Mini International Neuropsychiatric interview (MINI) criteria for major depression, schizophrenia, bipolar illness, delirium or psychosis.
• 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.
• Has Suicidal Risk Assessment (SRA) scores ≥ 6.
• Use of monoamine oxidase inhibitors within 14 days of study entry.
• Diagnosed with melanoma or lymphoma cancer of the head and neck.
• Diagnosed with Stage I or II pancreatic cancer or with anticipated survival of less than three months.
• History of allergic reactions or hypersensitivity to ketamine.
• Severe cardiac insufficiency (NYHA III or IV), with uncontrolled and/or unstable cardiac or coronary artery disease.
• History of significant tachyarrhythmia, severe angina, or myocardial ischemia
• Poorly controlled hypertension (Systolic Blood Pressure \> 180 mmHG or Diastolic Blood Pressure \> 100 mmHG), with or without antihypertensives.
• 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.
• Score of ≥ 8 on the WHO Alcohol Use Disorders Identification Test (AUDIT, sensitivity of 0.8).

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Pancreatic Neoplasms; Depression

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Scott Irwin, MD, PhD

  Cedars-Sinal Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Psychiatry & Behavioral Neurosciences

Study Record Dates

• First Submitted: May 7, 2015
• First Posted: May 13, 2015
• Study Start: August 15, 2016
• Primary Completion: November 3, 2017
• Study Completion: November 3, 2017
• Last Updated: November 6, 2018

Record last verified: 2018-11

Locations

US (1)