Ketamine for Preventing Depression in Patients Undergoing Treatment for Pancreatic or Head and Neck Cancers
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02442739|
Recruitment Status : Withdrawn (PI voluntary closure due to low accrual)
First Posted : May 13, 2015
Last Update Posted : November 6, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer Pancreatic Cancer Depression||Drug: Ketamine Other: Placebo||Early Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Actual Study Start Date :||August 15, 2016|
|Actual Primary Completion Date :||November 3, 2017|
|Actual Study Completion Date :||November 3, 2017|
oral ketamine 0.5 mg/kg mixed with syrup
Ketamine 0.5 mg/kg mixed with syrup will be given by mouth once a week for 12 weeks.
Other Name: Ketalar
Placebo Comparator: Placebo
oral placebo (syrup)
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 [ Time Frame: 36 months ]Subjects with a baseline and one post-baseline visit are evaluable and will be included in the analyses.
- Treatment-related adverse events [ Time Frame: 4 months ]Adverse Events rated as possibly/probably related to study treatment
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02442739
|United States, California|
|Cedars-Sinai Medical Center|
|Los Angeles, California, United States, 90048|
|Principal Investigator:||Scott Irwin, MD, PhD||Cedars-Sinal Medical Center|