This phase III trial tests the effect of ketamine on reducing chronic (long term) pain after mastectomy (surgery to remove the breast). Ketamine is an US Food and Drug Administration (FDA) approved, non-opioid drug that has been safely used clinically over the last 50 years. Ketamine is commonly used as a general anesthetic (medication that helps patients sleep during surgery) and, at low-doses (< 1 mg/kg, similar to the doses in this study), is used as an analgesic (medication that helps reduce pain). Giving ketamine during or after surgery may help with better pain control, improved mood, function, and decrease use of opioids.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05037123.
PRIMARY OBJECTIVE:
I. To determine the effectiveness of continuous ketamine infusion and single-dose ketamine to reduce pain at the surgical site at 3 months compared to placebo.
SECONDARY OBJECTIVES:
I. To determine the effectiveness of single-dose vs continuous ketamine versus (vs) placebo on reducing pain severity and pain interference at multiple time points within 12 months after surgery.
II. To determine the effectiveness of single-dose vs continuous ketamine vs placebo on reducing the incidence of post-mastectomy pain syndrome (PMPS).
III. To determine the effectiveness of single-dose vs continuous ketamine vs placebo on pain in the surgical site (chest wall, axilla, and/or arm).
IV. To determine the effect of single-dose vs continuous ketamine vs placebo on anxiety and depressed mood.
TERTIARY/EXPLORATORY OBJECTIVES:
I. To determine the effectiveness of single-dose vs continuous ketamine vs placebo on reducing pain at multiple time points after receiving treatment.
II. To determine the effect of single-dose vs continuous ketamine vs placebo on neuropathic symptoms.
III. To determine the effect of single-dose vs continuous ketamine vs placebo on fatigue.
IV. To determine the effect of single-dose vs continuous ketamine vs placebo on sleep quality and duration.
V. To determine the effect of single-dose vs continuous ketamine vs placebo on physical function.
VI. To determine the effect of single-dose vs continuous ketamine vs placebo on opioid use.
VII. To screen participants for any tobacco, alcohol, and perception drug abuse behaviors throughout the course of the trial.
VIII. To determine the effect of single-dose vs continuous ketamine vs placebo on anxiety and depressed mood.
OUTLINE: Patients are randomized to 1 of 3 arms.
ARM I: Patients receive ketamine intravenously (IV) infusion during surgery and over 2 hours after surgery. Patients also receive saline IV once after surgery.
ARM II: Patients receive saline IV infusion during surgery and over 2 hours after surgery. Patients also receive ketamine IV once after surgery.
ARM III: Patients receive saline IV infusion during surgery and over 2 hours after surgery. Patients also receive saline IV once after surgery.
After completion of study treatment, patients are followed up at 1 and 7 days, and then 1, 3, 6, and 12 months.
Trial PhasePhase III
Trial Typesupportive care
Lead OrganizationLaura and Isaac Perlmutter Cancer Center at NYU Langone
Principal InvestigatorJing Wang
