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About
This clinical trial evaluates whether it is possible to use a single dose of ketamine in combination with talk therapy to treat moderate to severe demoralization in patients with stage 3 or 4 gastrointestinal (GI) cancers who take opioids for cancer-related pain. Advanced stage gastrointestinal (GI) cancer patients often suffer from high rates of psychosocial distress and pain. Symptoms of anxiety are highly prevalent among gastrointestinal (GI) cancers patients. While opioid analgesia (pain reliever) succeeds in managing some symptoms, chronic opioid therapy is associated with significant adverse effects, underscoring a need to identify alternative interventions in the treatment of cancer associated pain. GI cancer patients frequently suffer from existential distress, and demoralization is a form of existential distress that is common among people with serious medical illnesses. Demoralization is characterized by poor coping with stressful events, and a loss of meaning and purpose in life. Talk therapy is a form of psychological treatment during which patients discuss problems, thoughts, and feelings. Ketamine has demonstrated efficacy for the treatment of depression, suicidality, and pain in non-cancer patients. This study may help researchers learn whether ketamine and talk therapy combined may improve psychosocial distress and pain, as well as decreases opioid analgesic use in patients with advanced GI cancer who take opioids for cancer-related pain.
Full description
PRIMARY OUTCOMES:
I. To assess the feasibility of Meaning and Purpose therapy combined with oral ketamine (K-MaP) in demoralized participants.
SECONDARY OUTCOMES:
I. To characterize the preliminary safety and tolerability of K-MaP in demoralized participants with stage 3 or 4 gastrointestinal (GI) cancers.
II. To assess the magnitude and durability of improvement from randomization in psychosocial distress.
III. To assess the magnitude and durability of improvement from randomization in pain.
IV. To assess the magnitude of change from randomization in opioid analgesic use.
V. To assess the magnitude and durability of change from randomization in interoceptive awareness
EXPLORATORY OBJECTIVES:
I. To assess how the participant's subjective experiences with ketamine may be related to clinical outcomes.
II. To assess how participants' stage of cancer may be related to clinical outcomes.
III. To assess how the participants' changes in measures of cardiac interoception following receipt of ketamine may be related to subjective experiences with ketamine and clinical outcomes.
OUTLINE:
Adult participants with advanced stage GI cancers receiving care at the Helen Diller Family Comprehensive Cancer Center (HDFCCC) will be randomized in a 1:1 ratio to one of two double-blinded conditions consisting of a single drug treatment and several therapy sessions. Participants will be followed up to 35 days (+/-2 days) after ketamine administration.
Enrollment
Sex
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Volunteers
Inclusion criteria
Must have a diagnosis of a stage 3 or 4 primary GI (i.e., pancreatic, colorectal, hepatocellular, biliary, and gastro-esophageal) cancer.
Must be willing to sign the informed consent form (ICF) and follow the study procedures as outlined in the ICF for the duration of the study.
Must be 18 years or older.
Must speak English and/or Spanish
Must have a Palliative Performance Score (PPS) v. 2.0 greater than or equal to 40%.
Must be able to swallow liquid oral medication.
Clinically significant moderate to severe demoralization as assessed by the Demoralization Scale-II (DS-II).
Must discontinue the following medications and refrain from taking following medications for the duration of study participation (participants who require these medications will be taken off study):
Female-born participants of child-bearing potential with male-born partners must use highly effective contraception for at least 1 month prior to ketamine administration (on day 0) and agree to use such a method for an additional 2 months after ketamine administration.
Male-born participants with female-born partners of child-bearing potential must use highly effective contraception for at least 1 month prior to ketamine administration and agree to use such a method for an additional 2 months after ketamine administration. Note: Highly effective contraception include:
Must agree to the following life-style considerations:
Note: Input will be obtained from the participant's regular clinical providers on appropriate pain management for the participant during the study, particularly in the case of analgesics associated with adverse reactions of concern with ketamine (e.g., tramadol and any opioid may increase risk of respiratory depression from ketamine).
Exclusion criteria
Has a known allergic or severe reactions to the non-psychoactive components of liquid ketamine.
Has received treatment with another investigational drug or intervention within 1 month of signing Informed Consent Form (ICF).
Is deemed by clinical judgment of the study investigators to be unsafe for undergoing the intervention.
Recent use of ketamine for non-anesthesia purposes.
Frequent use of ketamine over lifetime.
Has a history of intra-cerebral hemorrhage.
Has cognitive impairment sufficient to impede the ability to complete study tasks.
Has had delirium/encephalopathy within 3 months of signing ICF.
Has a history of intracranial hemorrhage.
Has had a stroke (embolic) within 12 months of signing ICF.
Has had a seizure within 6 months of signing ICF.
Currently has an intracranial mass (e.g., primary tumor or brain metastasis).
Has an advanced stage of a neurologic disease that puts participants at elevated risk for psychosis (e.g., Parkinson or Huntington disease).
Has a history of a primary psychotic disorder or primary bipolar disorder I or II (determined by Quick Structured Clinical Interview for Diagnostic and Statistical Manual version 5 Disorders (QuickSCID-5)).
Has a history of dissociative disorder.
Recent active suicidal ideation. Note: This does not include requesting medical aid in dying.
Is currently receiving electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS) or similar somatic therapies.
Has baseline hypertension (≥150 SBP or ≥90 DBP), after repeated measurements. Note: Participants with hypertension that has been controlled by medication down to <150 Systolic blood pressure (SBP) and <90 diastolic blood pressure (DBP) will be allowed participate.
Has a history of aneurysmal vascular disease or dissection (including thoracic and abdominal aorta, intracranial and peripheral arterial vessels) or arteriovenous malformation.
Has had cardiac arrest within 12 months of signing ICF.
Has had a myocardial infarction within 12 months of signing ICF.
Has QT Corrected for Heart Rate using Fridericia's Formula (QTcf) >480msec on 12-lead EKG. Note: Participants may qualify for the study if corrected QT Interval (QTc) 480-500 msec on one EKG, but then <=480 msec on repeat EKG taken >1 day later. If QT-prolonging medications are started or increased in dose after enrollment and prior to ketamine administration, a repeat EKG must be done >12-hours after this change in order to assure continued safe enrollment in the trial.
Has clinically significant arrhythmia defined as
Has symptomatic congestive heart failure (NYHA Class II-IV)
Has severe obstructive intracardiac abnormalities (e.g., aortic stenosis)
Has any current condition where physical activity is associated with palpitations, anginal pain or syncope.
Is unable to protect their own airway due to dysphagia, difficulty swallowing or a neurologic disease resulting in a risk of aspiration.
Has a history of flash pulmonary edema within 12 months of signing ICF.
Has a diagnosis of moderate or severe pulmonary hypertension.
Needs supplemental oxygen (intermittent or continuous).
Has current intractable nausea/vomiting/diarrhea.
Meets the following laboratory parameters:
Is currently pregnant or breastfeeding.
Has insulin-dependent diabetes with diabetes-related hospitalization within 6 months of signing ICF.
Primary purpose
Allocation
Interventional model
Masking
1 participants in 2 patient groups
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Central trial contact
Zoe Lopez-Meraz
Data sourced from clinicaltrials.gov
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