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Low-Dose Colchicine for Radiation Therapy Side Effects
Study 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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- 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 am scheduled for high-dose radiation or combined treatment to my head or neck.I am 8 years or older and have a confirmed diagnosis of head and neck cancer.I have skin issues like rashes or open wounds where I will be treated.I am fully active or restricted in physically strenuous activity but can do light work.I can sign a consent form.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.
- Group 1: Experimental arm - oral colchicine once a day
- Group 2: Standard of care arm - placebo colchicine pill
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
How many people are taking part in this experiment at most?
"That is correct. The listing on clinicaltrials.gov affirms that this study, which was first publicized on May 10th 2022, has an ongoing recruitment process. They are looking for 30 individuals total from 2 different locations."
What is the FDA's official stance on oral colchicine(0.6 mg) once a day?
"While Phase 1 trials offer limited data supporting a medication's safety and efficacy, our team believes that oral colchicine is safe to use (scoring a 1 on our scale)."
Are there any spaces available for new participants in this experiment?
"The most up-to-date information on clinicaltrials.gov reveals that this study is still recruiting patients. This trial was originally posted on May 10th, 2022 and has since undergone one edit on October 18th, 20222."
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What portion of applicants met pre-screening criteria?
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