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.
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 therapy during the study period.
Palliative or non-curative intent radiotherapy.
Known carotid artery stenosis ≥50% at baseline screening.
Prior history of radiotherapy to the neck (other than the qualifying course of RT for this study), carotid artery dissection, or prior carotid revascularization (endarterectomy or stenting).
Known hypersensitivity or prior intolerance to colchicine.
Single group
Colchicine
Drug0.6 mg given by mouth once daily for 24 months
Placebo
Other interventionGiven by mouth once daily for 24 months
Safety and Adverse Events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 6.0
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This trial is not recruiting at the moment. You can still explore other options:
