Ketamine-assisted Therapy for Advanced GI Cancer (NCT06077487) | Clinical Trial Compass
TerminatedPhase 4
Ketamine-assisted Therapy for Advanced GI Cancer
Stopped: Slow Accrual
United States1 participantsStarted 2024-05-17
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion Eligible Versus Screened Participants.
Timeframe: Up to 28 days
2
Proportion of Participants Who Complete Therapy
Timeframe: Up to 49 days
3
Frequency of Participant Responses to Intervention Acceptability
. 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):
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.