2024-05-17
2025-01-31
2025-01-31
1
NCT06077487
University of California, San Francisco
University of California, San Francisco
INTERVENTIONAL
Ketamine-assisted Therapy for Advanced GI Cancer
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2023-10-05 | N/A | 2025-03-03 |
2023-10-05 | N/A | 2025-03-06 |
2023-10-11 | N/A | 2025-02 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Supportive Care
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
Triple
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Group A (K-MaP) Participants will receive 0.5mg/kg of Ketamine orally with an equivalent quantity of placebo via an intramuscular injection on Day 0/Visit 4 and receive Meaning and Purpose (MaP) therapy 4 times, twice before (between days -13 and -1) ketamine administrat | DRUG: Ketamine
BEHAVIORAL: Meaning and Purpose therapy
OTHER: Placebo
OTHER: Questionnaires
|
| EXPERIMENTAL: Group B (K-Map) Participants will receive 0.5mg/kg of Ketamine IM with a placebo oral solution on Day 0/Visit 4 and receive Meaning and Purpose (MaP) therapy 4 times, twice before (between days -13 and -1) ketamine administration, and twice afterward on days 3 (+/- 2 day | DRUG: Ketamine Injectable Product
BEHAVIORAL: Meaning and Purpose therapy
OTHER: Placebo
OTHER: Questionnaires
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Proportion eligible versus screened participants. | The rate of recruitment is defined as the proportion of eligible participants who participate compared to the number of total participants who were screened or signed consent but did not meet eligibility criteria will be reported. | Up to 28 days |
| Proportion of participants who complete therapy | Proportion of enrolled participants completing K-MaP intervention and all Demoralization Scale II (DS-II) assessments will be reported. | Up to 49 days |
| Frequency of participant responses to intervention acceptability | The participants will provide qualitative feedback on the acceptability of the intervention via a 20-minute interview with the study team upon study termination. Frequency of responses will be categorized and reported by arm. | 1 day |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Percentage of participants reporting treatment-emergent adverse events | The percentage of participants in each arm reporting treatment-related adverse events will be reported. Pre-determined criteria for assessment of tolerability to K-MaP include zero treatment-related serious adverse events, and all other adverse events will be assessed using Common Terminology Criteria for Adverse Events version 5.0. | Up to 49 days |
| Percentage of participants with clinically significant changes in blood pressure | At time of ketamine administration, participants blood pressure will be monitored for any clinically significant changes. The percentage of participants with a clinically significant change in blood pressure from pre-medication administration to end of study visit will be reported. | 1 day |
| Percentage of participants with clinically significant changes in heart rate | At time of ketamine administration, participants heart rate will be monitored for any clinically significant changes. The percentage of participants with a clinically significant change in heart rate from pre-medication administration to end of study visit will be reported. | 1 day |
| Mean scores on the Challenging Experience Questionnaire (CEQ) over time | The CEQ is a 26-item, self-reported measure of challenging experiences with psychedelics. The CEQ assesses seven factors: grief (5 items), fear (6 items), subjective experience of death (2 items), insanity (3 items), isolation (3 items), physical distress (5 items), and paranoia (2 items). Each of the 26 items is scored on a 5-point Likert scale (0 = "None; not at all" to 5 = "Extreme [more than ever before in my life]"). Participants are asked to rate each item based on the degree to which each item was experienced. A higher total CEQ score indicates greater psychologically adverse reactions to psilocybin. | 1 day |
| Mean clinician-rated scores on the Global Clinical impression of severity (CGI-S) over time | The CGI is a 3-item clinician-administered measure developed by the National Institute of Mental Health to assess clinical change in participants in psychopharmacology trials. This study will be using the Global Impression of Severity item ("Considering your total clinical experience with participants with demoralization, how would you rate this participant's level of demoralization at this time?"), on the scale from "1 = Normal, not at all demoralized" to "7 = Among the most extremely demoralized participants" to assess change in demoralization. | Up to 49 days |
| Mean clinician-rated scores on the Demoralization Interview (DI) over time | The DI is a clinician-rated measure of demoralization which consists of 14-items designed from items of the Demoralization Scale II. The items measure events that occurred over the past 2 weeks, which are scored on a 3-point scale ranging from 0 to 2. Scores are calculated by adding each item score, for a total score range of 0 to 28. Higher scores indicate a greater degree of demoralization. | Up to 49 days |
| Mean clinician-rated scores on the GRID-Hamilton Depression Rating Scale (GRID-HAMD) over time | The 6-item Hamilton Depression Rating Scale (HAMD-6) is a validated, brief, clinician-rated measure of the core symptoms of major depression. With permission from authors (the International Society for Central Nervous System Drug Development (ISCDD)) a modified, 6-items version of the HAMD-6 in the GRID-HAMD format to will be used by clinicians to create a brief, responsive and reliable measure of core depression symptoms of participants. Responses on the items will range from 0=absent; 1=mild; 2=moderate; 3=severe; 4=incapacitating and scores will be summed to create a total score. The higher the total score the more severe the depression symptoms of the participant. | Up to 49 days |
| Proportion of participants with reported demoralization based on the Diagnostic Criteria in Psychosomatic Research (DCPR) Demoralization scale. | The DCPR is a structured, clinician-administered, interview regarding various psychosomatic conditions and will be administered to participants over the course of the study. Clinicians will record the rates of demoralization as present or not per participant | Up to 49 days |
| Mean scores on the Demoralization Scale II (DS-II) over time | The DS-II is a measure of demoralization which consists of 16-items designed from items of the Demoralization Scale II. The items measure events that occurred over the past 2 weeks, which are scored on a 3-point scale ranging from 0 to 2. Scores are calculated by adding each item score, for a total score range of 0 to 32. Higher scores indicate a greater degree of demoralization. | Up to 49 days |
| Mean scores on the Patient Health Questionnaire 9 (PHQ-9) over time | The Patient Health Questionnaire-9 (PHQ-9) is used to measure depression symptoms. The total Patient Health Questionnaire-9 (PHQ-9) score is calculated by combining the responses of the participant on questions addressing how bothered the participant has been by various problems over the past 2 weeks. Each of the 9 items is scored on a scale of 0 ("Not bothered at all") to 4 ("Nearly every day"). A total score of 5-9='Mild Depression Symptoms", 10-14="Minor Depression, Major Depression (mild), or Dysthymia", 15-19="Major Depression, moderately severe", and >20="Major Depression". | Up to 49 days |
| Mean scores on the Generalized Anxiety Disorder 7 (GAD-7) over time | The GAD-7 is a seven-item instrument that is used to measure or assess the severity of generalized anxiety disorder. The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of "not at all," "several days," "more than half the days," and "nearly every day," respectively, and then adding together the scores for the seven questions. Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively. When used as a screening tool, further evaluation is recommended when the score is 10 or greater. | Up to 49 days |
| Mean scores on the Functional Assessment of Chronic Illness Therapy Palliative Care, 14 Item Version (FACIT-Pal-14) (FACIT-Pal-14) over time | The FACIT-Pal-14 is a 14-item, self-report measure of quality of life in palliative care participants. The measure has a 7-day recall period with responses to items which fall on a 5-point Likert scale, with scores ranging from 0 = "Not at all" to 4 = "Very much". Scores are summed to create a total score of 0 to 56, with higher scores indicating a greater quality of life. | Up to 49 days |
| Mean scores on the Brief-Pain Inventory Short Form (BPI-SF) over time | The BPI-SF is a 9-item questionnaire used to assess the severity of pain and the impact of pain on activities of daily living over a recall period of 24 hours. Pain severity is assessed across four sub-scales; 'worst pain', 'least pain', 'average pain' and 'current pain'. A pain score for each subscale is presented separately. Scales are rated on a scale of 0 to 10 (0 = no pain; 10 = pain as bad as one can imagine). A composite score for pain severity is calculated as the mean of the four severity items. Question 9 comprises a 7-item interference scale. Questions assess the level to which pain interferes with general activity, walking, work, mood, enjoyment of life, relations with others and sleep on a scale of 0 to 10 (0 = does not interfere; 10 = completely interferes). Mean interference score will be calculated as an average of the seven subparts of question 9 where at least four of the seven items are completed. | Up to 49 days |
| Proportion of participants reporting any use of opioids | Using the Morphine Milligram Equivalents (MME) calculation, participants cumulative daily dose of opioids will be calculated for the past 24 hours at each study visit. The proportion of participants with any reported opioid use at any of the study visits will be reported. | Up to 49 days |
| Mean scores on the Multidimensional Assessment of Interoceptive Awareness, Version 2 (MAIA-2) | The MAIA-2 is a validated a widely used questionnaire to measure interoceptive awareness. This measure consists of 37-items using a 6-point Likert scale (0 = "Never" to 5 = "Always"). The MAIA-2 has demonstrated good internal consistency and reliability for the evaluation of clinical mind-body interventions, with higher scores indicating increased awareness. | Up to 49 days |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
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