Back to resultsKetamine for Preventing Depression in Patients Undergoing Treatment for Pancreatic or Head and Neck Cancers
Primary Purpose
Head and Neck Cancer, Pancreatic Cancer, Depression
Status
Withdrawn
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ketamine
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Head and Neck Cancer focused on measuring Ketamine, Prevention of depression
Eligibility Criteria
Inclusion Criteria:
- 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.
- 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.
- 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.
Exclusion Criteria:
- 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).
Sites / Locations
- Cedars-Sinai Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Ketamine
Placebo
Arm Description
oral ketamine 0.5 mg/kg mixed with syrup
oral placebo (syrup)
Outcomes
Primary Outcome Measures
Proportion of patients pre-screened that were potentially eligible for study participation.
Proportion of patients that were potentially eligible who were approached.
Proportion of approached patients that decline study participation and why.
Proportion of approached patients that agreed to participate.
Proportion of approached that were randomized.
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.
Proportion of patients that are evaluable
Subjects with a baseline and one post-baseline visit are evaluable and will be included in the analyses.
Secondary Outcome Measures
Treatment-related adverse events
Adverse Events rated as possibly/probably related to study treatment
Patient-reported tolerability questionnaire (FIBSER)
Treatment expectancy and satisfaction as measured by the credibility/expectancy questionnaire (CEQ).
Full Information
NCT ID
NCT02442739
First Posted
May 7, 2015
Last Updated
November 2, 2018
Sponsor
Cedars-Sinai Medical Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT02442739
Brief Title
Ketamine for Preventing Depression in Patients Undergoing Treatment for Pancreatic or Head and Neck Cancers
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Withdrawn
Why Stopped
PI voluntary closure due to low accrual
Study Start Date
August 15, 2016 (Actual)
Primary Completion Date
November 3, 2017 (Actual)
Study Completion Date
November 3, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cedars-Sinai Medical Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer, Pancreatic Cancer, Depression
Keywords
Ketamine, Prevention of depression
7. Study Design
Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ketamine
Arm Type
Experimental
Arm Description
oral ketamine 0.5 mg/kg mixed with syrup
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
oral placebo (syrup)
Intervention Type
Drug
Intervention Name(s)
Ketamine
Other Intervention Name(s)
Ketalar
Intervention Description
Ketamine 0.5 mg/kg mixed with syrup will be given by mouth once a week for 12 weeks.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo syrup will be given by mouth once a week for 12 weeks.
Primary Outcome Measure Information:
Title
Proportion of patients pre-screened that were potentially eligible for study participation.
Time Frame
36 months
Title
Proportion of patients that were potentially eligible who were approached.
Time Frame
36 months
Title
Proportion of approached patients that decline study participation and why.
Time Frame
36 months
Title
Proportion of approached patients that agreed to participate.
Time Frame
36 months
Title
Proportion of approached that were randomized.
Time Frame
36 months
Title
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
Title
Proportion of patients that are evaluable
Description
Subjects with a baseline and one post-baseline visit are evaluable and will be included in the analyses.
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Treatment-related adverse events
Description
Adverse Events rated as possibly/probably related to study treatment
Time Frame
4 months
Title
Patient-reported tolerability questionnaire (FIBSER)
Time Frame
4 months
Title
Treatment expectancy and satisfaction as measured by the credibility/expectancy questionnaire (CEQ).
Time Frame
4 months
Other Pre-specified Outcome Measures:
Title
Incidence of new onset mild, moderate, or severe depressive symptoms as assessed by questionnaire (QIDS-SR-16)
Time Frame
4 months
Title
Depression-free survival
Time Frame
4 months
Title
Severity of cancer-related pain as assessed by a visual analog scale (VAS)
Time Frame
4 months
Title
Anxiety and depressive symptoms as assessed by questionnaire (HADS)
Time Frame
4 months
Title
Quality of life as assessed by questionnaire (UW-QOL)
Time Frame
4 months
Title
Suicide risk and ideation as assessed by questionnaire (SRA)
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
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.
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.
Exclusion Criteria:
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott Irwin, MD, PhD
Organizational Affiliation
Cedars-Sinal Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Ketamine for Preventing Depression in Patients Undergoing Treatment for Pancreatic or Head and Neck Cancers
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