A Ph2, Colchicine For Inflammatory Carotid Injury And Disease Evolution After Radiotherapy

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT07856719
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Colchicine — DRUG
    0.6 mg given by mouth once daily for 24 months
  • Placebo — OTHER
    Given by mouth once daily for 24 months

Study Details

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.

Key Dates

First listed
Oct 5, 2026
Start date
Mar 1, 2027
Status verified
Sep 2026
Primary completion
Jul 1, 2032
Completion
Jul 1, 2034

Study Design

Enrollment
250 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Double- blind Treatment with Colchicine or Placebo
    Treatment will be administeredon an outpatient basis

Primary Outcome Measure

Safety and Adverse Events (AEs) [ Time Frame: Through study completion; an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UT MD AndersonHoustonTexas77030
Efstratios Koutroumpakis, MD
[email protected]
713-563-5439
Efstratios Koutroumpakis, MD (PRINCIPAL_INVESTIGATOR)

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By condition
Head and neck cancer
By specialty
OncologyENT
By research site
UT MD Anderson· Houston, TX

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