Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT05086250
EARLY_PHASE1

Feasibility Study of Oral Ketamine Versus Placebo for the Treatment of Anxiety in Patients With Pancreatic Cancer

Sponsor: Cedars-Sinai Medical Center

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2022-10-20

Completion Date

2026-12

Last Updated

2026-01-07

Healthy Volunteers

No

Interventions

DRUG

Ketamine

Weekly 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).

DRUG

Placebo

Weekly 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).

DRUG

Placebo

Weekly 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).

DRUG

Ketamine

Weekly 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).

Locations (1)

Cedars-Sinai Medical Center

Los Angeles, California, United States