This randomized phase II trial studies how well giving ketamine hydrochloride works in reducing pain in patients with mucositis undergoing chemoradiation or radiation therapy for head and neck cancer. Ketamine hydrochloride may lessen the side effects of treatment for head and neck cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT01653327.
PRIMARY OBJECTIVES:
I. To determine the reduction in pain score by ketamine mouthwash (ketamine hydrochloride) compared to placebo in head and neck cancer patients with refractory mucositis.
SECONDARY OBJECTIVES:
I. To describe the duration of analgesia and adverse effects associated with ketamine and placebo.
OUTLINE: Patients are randomized to 1 of 2 treatment groups.
GROUP A: Patients receive ketamine hydrochloride mouthwash on days 1 and 5 and placebo mouthwash on day 3.
GROUP B: Patients receive placebo mouthwash on days 1 and 5 and ketamine hydrochloride mouthwash on day 3.
In both groups, treatment continues for up to 6 weeks.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationDartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Principal InvestigatorThomas Horton Davis