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Alkaloid

Low-Dose Colchicine for Radiation Therapy Side Effects

Phase 1
Recruiting
Led By Bruce Haffty, MD
Research Sponsored by Rutgers, The State University of New Jersey
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Stage 1-3 HNC pathologically confirmed diagnosis of squamous cell carcinoma of the oropharynx, larynx, hypopharynx, nasopharyngeal, or oral cavity
o Stage 1-3 HNC pathologically confirmed diagnosis of squamous cell carcinoma of the oropharynx, larynx, hypopharynx, nasopharyngeal, or oral cavity
Must not have
Pre-existing skin rashes, ulcerations, or open wounds in the treatment area
Estimated glomerular filtration rate (GFR) < 55 ml/min since colchicine should not be given
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial is studying a medication called low-dose colchicine to see if it can prevent or reduce skin problems caused by radiation therapy in patients with head and neck cancer.

Who is the study for?
This trial is for adults (18+) with head and neck cancer (HNC) who are in good physical condition, about to receive radiation therapy, and can consent to the study. It's not for those with severe kidney or liver disease, previous head/neck radiation, certain skin conditions in the treatment area, pregnant or breastfeeding women, current colchicine users, or anyone taking drugs that might interfere with the study.
What is being tested?
The trial tests if a low dose of oral colchicine (0.6 mg daily) can prevent or treat skin issues caused by radiation therapy in patients with HNC. Participants will take a quick daily pill and answer survey questions during follow-up visits to assess effectiveness.
What are the potential side effects?
Colchicine may cause side effects like digestive upset (nausea/vomiting), diarrhea, fatigue, muscle pain/weakness. Rarely it could lead to serious blood disorders or muscle damage especially at higher doses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is a type of throat or mouth cancer that has not spread widely.
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My cancer is in the head or neck area and not beyond stage 3.
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I am 8 years or older and have a confirmed head and neck cancer diagnosis.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I am planning to undergo intensive radiotherapy or combined treatment for my head or neck cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have skin issues like rashes or open wounds where I will be treated.
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My kidney function is reduced, with a GFR less than 55 ml/min.
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I have had radiation therapy to my head or neck.
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My cancer has spread to distant parts of my body or has come back in the same area.
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I am currently taking cetuximab or similar drugs to enhance radiation therapy.
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My liver is severely ill or my liver enzyme levels are high.
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I am currently taking colchicine for a condition like gout or FMF.
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I am taking high doses of pain relievers like ibuprofen.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Pain - Visual Analogue Scale (VAS)
Secondary study objectives
Erythema - Common Toxicity Criteria for Adverse Events (CTCAE)
Other study objectives
Health-Related Quality-of-Life - Quality of Life Questionnaire
Health-Related Quality-of-Life - Questionnaire

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental arm - oral colchicine once a dayExperimental Treatment1 Intervention
The experimental arm will receive 0.6 mg of oral colchicine once a day
Group II: Standard of care arm - placebo colchicine pillActive Control1 Intervention
The standard of care arm will receive a placebo colchicine pill once a day

Find a Location

Who is running the clinical trial?

Rutgers, The State University of New JerseyLead Sponsor
452 Previous Clinical Trials
69,482 Total Patients Enrolled
1 Trials studying Radiation Therapy
156 Patients Enrolled for Radiation Therapy
Bruce Haffty, MDPrincipal InvestigatorRutgers Cancer Institute of New Jersey
3 Previous Clinical Trials
469 Total Patients Enrolled

Media Library

Colchicine (Alkaloid) Clinical Trial Eligibility Overview. Trial Name: NCT05335148 — Phase 1
Radiation Therapy Research Study Groups: Standard of care arm - placebo colchicine pill, Experimental arm - oral colchicine once a day
Radiation Therapy Clinical Trial 2023: Colchicine Highlights & Side Effects. Trial Name: NCT05335148 — Phase 1
Colchicine (Alkaloid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05335148 — Phase 1
~8 spots leftby Dec 2025
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