This phase II trial test whether escitalopram working in preventing or reducing depression and improving quality of life in patients with pancreatic cancer that has not spread to other parts of the body (localized) or that has spread to nearby tissue or lymph nodes (locally advanced). Escitalopram is a drug that works by increasing the amount of a chemical called serotonin in the brain. Having more serotonin may help decrease the symptoms of depression and anxiety. Giving escitalopram may help prevent or reduce depression symptoms and improve quality of life and cancer survival in patients with localized or locally advanced pancreatic cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05289830.
PRIMARY OBJECTIVE:
I. To obtain preliminary evidence of the efficacy of daily escitalopram oxalate (escitalopram) in reducing depression in patients with localized pancreatic or periampullary cancer receiving neoadjuvant therapy.
SECONDARY OBJECTIVES:
I. To determine depression rates in patients with resected pancreatic cancer at baseline and at 12 weeks.
II. To determine if daily escitalopram improves the quality of life in patients with localized pancreatic and periampullary cancer.
III. To determine if daily escitalopram improves survival in patients with resected pancreatic cancer.
IV. Study tissues and serum to determine if molecular markers of the serotonintryptophan-kynurenine pathway are associated with depression scores.
V. Study tissues and serum to determine if molecular markers of the serotonintryptophan-kynurenine pathway are associated with the efficacy of anti-depressants in patients with pancreatic cancer.
VI. Test for an association between tryptophan intermediates and immune profile in tumors and blood of patients with pancreatic cancer.
EXPLORATORY OBJECTIVE:
I. Examine the impact of IDO2 polymorphisms in depression rates and response to antidepressants.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive escitalopram oxalate orally (PO) once daily (QD) for 12 weeks in the absence of unacceptable toxicity.
ARM II: Patients receive placebo PO QD for 12 weeks in the absence of unacceptable toxicity.
After completion of study treatment, patients are followed up at week 25 and then every 12 weeks for 3 years.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationCase Comprehensive Cancer Center
Principal InvestigatorJordan Michael Winter
