Safety Study of Ketamine for Preventing Depression in Patients Undergoing Treatment for Head and Neck Cancer
Information source: University of California, San Diego
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Head and Neck Cancer; Depression
Intervention: Ketamine (Drug); Placebo (Other)
Phase: Phase 0
Status: Recruiting
Sponsored by: University of California, San Diego Official(s) and/or principal investigator(s): Scott A Irwin, MD, PhD, Principal Investigator, Affiliation: University of California, San Diego
Overall contact: Larissa K Low, Phone: (858) 822-5223, Email: llow@ucsd.edu
Summary
The primary purpose of this study is to see if it is safe to give patients with head and
neck cancer a low dose of the FDA approved anesthetic drug ketamine at the same time they
receive radiation, chemotherapy, and/or surgery 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.
The American Psychiatric Association has reported that up to about half of patients with
head and neck cancer develop depression which has many negative impacts on cancer care and
its outcomes. 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.
Clinical Details
Official title: Piloting a Randomized Feasibility Study of Oral Ketamine Versus Placebo for Prevention of Depression in Patients Undergoing Therapy for Head and Neck Cancer
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Proportion of patients approached for study participation that consented to participateProportion of eligible patients that participated
Secondary outcome: treatment-related adverse eventspatient-reported tolerability questionnaire (FIBSER)
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 cancer undergoing curative intent cancer therapy. Approximately 20 patients
with head and neck 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 16 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 six-month
follow-up period.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Ability to understand and the willingness to sign a written informed consent.
2. Stage III or IV epidermoid cancer of the head and neck.
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.
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 her treating physician immediately.
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 Quick Inventory of Depressive
Symptomatology-Self Rated 16 (QIDS-SR-16) scores of ≥ 11.
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. History of allergic reactions or hypersensitivity to ketamine.
8. Severe cardiac insufficiency (NYHA III or IV), with uncontrolled and/or unstable
cardiac or coronary artery disease.
9. History of significant tachyarrhythmia, severe angina, or myocardial ischemia
10. Poorly controlled hypertension (Systolic Blood Pressure > 180 mmHG or Diastolic Blood
Pressure > 1000 mmHG), with or without antihypertensives.
11. Pregnant or nursing.
Locations and Contacts
Larissa K Low, Phone: (858) 822-5223, Email: llow@ucsd.edu
University of California, San Diego Moores Cancer Center, La Jolla, California 92093, United States; Recruiting Larissa K Low, Phone: 858-822-5223, Email: llow@ucsd.edu Scott A Irwin, MD, PhD, Principal Investigator
Additional Information
Starting date: May 2015
Last updated: May 12, 2015
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