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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 belowSelect...
My cancer is a type of throat or mouth cancer that has not spread widely.
Select...
My cancer is in the head or neck area and not beyond stage 3.
Select...
I am 8 years or older and have a confirmed head and neck cancer diagnosis.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
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:Select...
I have skin issues like rashes or open wounds where I will be treated.
Select...
My kidney function is reduced, with a GFR less than 55 ml/min.
Select...
I have had radiation therapy to my head or neck.
Select...
My cancer has spread to distant parts of my body or has come back in the same area.
Select...
I am currently taking cetuximab or similar drugs to enhance radiation therapy.
Select...
My liver is severely ill or my liver enzyme levels are high.
Select...
I am currently taking colchicine for a condition like gout or FMF.
Select...
I am taking high doses of pain relievers like ibuprofen.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 weeks
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is a type of throat or mouth cancer that has not spread widely.I am able to understand and sign the consent form.You are allergic to or cannot tolerate colchicine.I have skin issues like rashes or open wounds where I will be treated.My cancer is in the head or neck area and not beyond stage 3.My kidney function is reduced, with a GFR less than 55 ml/min.I have had radiation therapy to my head or neck.My cancer has spread to distant parts of my body or has come back in the same area.I am currently taking cetuximab or similar drugs to enhance radiation therapy.I am 8 years or older and have a confirmed head and neck cancer diagnosis.I am fully active or restricted in physically strenuous activity but can do light work.My liver is severely ill or my liver enzyme levels are high.I am currently taking colchicine for a condition like gout or FMF.You have known allergies or skin diseases that affect your whole body, even if they don't directly affect the areas being treated.I am taking high doses of pain relievers like ibuprofen.I am planning to undergo intensive radiotherapy or combined treatment for my head or neck cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of care arm - placebo colchicine pill
- Group 2: Experimental arm - oral colchicine once a day
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.