M.D. Anderson Cancer Center
The goal of this clinical research study is to find out if low-dose colchicine (an anti-inflammatory drug) lowers the rate of radiation-related side effects to the carotid artery in patients who have completed radiation therapy for head and neck cancer.
Primary Objective: To evaluate whether low-dose colchicine (0.6 mg orally once daily for 24 months) reduces radiation-induced carotid vascular injury compared to placebo in survivors of head and neck cancer who have completed curative-intent radiotherapy, as assessed by a hierarchical composite endpoint analyzed using the win ratio method, comprising: (1) time to death; (2) time to TIA, CVA, or ischemic heart disease; (3) time to carotid artery stenosis \>50%; and (4) change in carotid intima-media thickness (CIMT) from pre-radiotherapy baseline to 24 months postrandomization. Secondary Obje…
Inclusion Criteria: * Adults aged ≥18 years. * Clinical diagnosis of head and neck cancer (HNC), including malignancies of the oral cavity, oropharynx, hypopharynx, larynx, nasopharynx, or salivary glands. * Receipt of curative-intent radiotherapy to the neck, completed ≤18 months prior to randomization. * No evidence of locoregional or distant disease recurrence, confirmed by standard-of-care imaging at 3-6 months post-RT completion as documented by the treating head and neck radiation oncologist. Participants must not be scheduled to receive additional cancerdirected systemic or radiation t…
0.6 mg given by mouth once daily for 24 months
Given by mouth once daily for 24 months
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