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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
Capable of signing a written informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 weeks
Awards & highlights

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.

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.Check my eligibility
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.See study design
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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I am able to understand and sign the consent form.
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I am scheduled for high-dose radiation or combined treatment to my head or neck.
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I am 8 years or older and have a confirmed diagnosis of head and neck cancer.
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I am fully active or restricted in physically strenuous activity but can do light work.
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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.

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

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

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
426 Previous Clinical Trials
64,165 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: Experimental arm - oral colchicine once a day, Standard of care arm - placebo colchicine pill
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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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)."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
How old are they?
18 - 65
What site did they apply to?
Robert Wood Johnson University Hospital
What portion of applicants met pre-screening criteria?
Met criteria
~2 spots leftby Jun 2024