Feasibility Study of Oral Ketamine Versus Placebo for the Treatment of Anxiety in Patients With Pancreatic Cancer
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorCedars-Sinai Medical Center
About this trial
This is a prospective, single center, double blind, randomized, crossover feasibility study of oral ketamine versus placebo for the treatment of anxiety in patients with pancreatic cancer currently receiving or within 12 weeks of receiving cancer targeted therapy. The primary objective is to determine the feasibility of enrolling subjects and treatment adherence. The secondary objectives are to describe the safety and tolerability. Exploratory objectives are to assess the effect of ketamine/placebo on Depression, Anxiety, Physical Function, Pain Interference, Pain Intensity, Fatigue, Sleep Disturbance, and Ability to Participate in Social Roles and Activities as measured by PROMIS Anxiety Short Form 7a and the PROMIS-29 Profile v2.1 of Patient Reported Outcomes, as well as changes in circulatory inflammatory cytokines, blood glutamine levels, and other biomarkers of anxiety and/or depression.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Ability to understand and the willingness to sign a written informed consent.
Participant has been diagnosed with pancreatic cancer.
Receiving or within twelve weeks of having received cancer targeted treatment, including surgery, radiation, chemotherapy, immunotherapy, or other cancer targeted therapy.
Age ≥ 18 years.
Disqualifiers
Initial cancer diagnosis ≤6 weeks prior to Day 0.
Meets MINI International Neuropsychiatric Interview (MINI Plus), criteria for diagnoses of schizophrenia, bipolar illness, delirium or psychosis.
Scores ≥ 10 on the Suicidal Risk Assessment (SRA).
History of allergic reactions or hypersensitivity to ketamine.
Trial design
Design model
Crossover
Treatments tested in this trial
Ketamine
DrugWeekly oral administration of 0.5mg/kg ketamine for 4 weeks, followed by weekly oral administration of placebo for 4 weeks (separated by a washout period of 2 weeks).
Placebo
DrugWeekly oral administration of 0.5mg/kg ketamine for 4 weeks, followed by weekly oral administration of placebo for 4 weeks (separated by a washout period of 2 weeks).
Placebo
DrugWeekly oral administration of placebo for 4 weeks, followed by weekly oral administration of 0.5mg/kg ketamine for 4 weeks (separated by a washout period of 2 weeks).
Ketamine
DrugWeekly oral administration of placebo for 4 weeks, followed by weekly oral administration of 0.5mg/kg ketamine for 4 weeks (separated by a washout period of 2 weeks).
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Arm A: Ketamine Followed by PlaceboExperimental treatment 2 interventions
Group B: Arm B: Placebo Followed by KetamineExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Feasibility of enrolling subjects which will be measured by the proportion of patients dropping out of study for any reason prior to the end of treatment visit.
The following will be collected as part of this feasibility measurement: * Reasons for dropout. * 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 completing study through End of Treatment visit and each follow-up visit.
Time frame
2 monthsSecondary outcomes
1
To investigate the safety of oral ketamine in patients with pancreatic cancer and anxiety, which will be assessed by the number of adverse events related to study treatment per CTCAE v.5.
Th number of adverse events related to study treatment assessed per CTCAE v.5.
Time frame
3 months2
To investigate the tolerability of oral ketamine in patients with pancreatic cancer and anxiety, which will be measured by patient-reported Ketamine Adverse Symptom Checklist and Impact scores.
This is a self-report tool that provides patient rating (none, mild, moderate, severe) of 33 potential side effects of ketamine. The Adverse Symptom Checklist (ASC) is scored 0 (none), mild (1), moderate (2), and severe (3 points). This scale also asks patients to quantify side effect interference in daily activities, also scored the same way (Min value 0, Max Value 3). Therefore, the total score for the ASC has Min value 0, Max 102 where total higher scores mean a worse outcome. The ASC responses will be dichotomized (frequency: 0%-25% vs \>25%; intensity: none, mild vs moderate, or greater; burden: none to mild impairment vs moderate or greater impairment) and will be descriptively summarized by each treatment arm at each assessment time point.
Time frame
3 monthsSponsors and contacts
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Source ClinicalTrials.gov