NCT06077487

Ketamine-assisted Therapy for Advanced GI Cancer

Pilot Study of Ketamine-assisted Talk Therapy for Demoralization in Advanced GI Cancer

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Brian Anderson, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Pancreatic Ductal Adenocarcinoma
• Pain, Acute
• Gastrointestinal Cancers
• Demoralization

Interventions

Type	Name	Description
DRUG	Ketamine	Given orally (PO)
DRUG	Ketamine Injectable Product	Given intramuscularly (IM)
BEHAVIORAL	Meaning and Purpose therapy	In-person sessions
OTHER	Placebo	Given PO or IM
OTHER	Questionnaires	Questionnaires will be given over the course of the study

Timeline

• Start date: 2024-05-17
• Primary completion: 2025-01-31
• Completion: 2025-01-31
• First posted: 2023-10-11
• Last updated: 2025-05-21
• Results posted: 2025-05-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study