Study of DCA (Dichloroacetate) in Combination With Cisplatin and Definitive Radiation in Head and Neck Carcinoma
Status:
Completed
Trial end date:
2020-06-01
Target enrollment:
Participant gender:
Summary
This will be a randomized masked placebo-controlled single-center study to evaluate the
effects of Dichloroacetate (DCA) versus placebo given in combination with Cisplatin and
radiation treatment in patients with Stage III-IV Squamous Cell Carcinoma of the Head and
Neck (SCCHN). Fifty subjects will be enrolled and randomly assigned on a 1:1 ratio to DCA or
matching placebo given with standard of care treatment consisting of Cisplatin and radiation
treatment.
Patients will receive DCA/placebo PO or per G-tube twice a day for 8 weeks. The first 6
patients of the total study population will represent a safety lead-in cohort. The results of
the safety lead-in of DCA/placebo in combination with Cisplatin and radiation therapy will be
evaluated after the 6th patient has completed 8 weeks of therapy. Recruitment of patients
will be withheld during safety data analysis.