Study to Evaluate the Safety of Colchicine

Evaluate the Safety of Colchicine for Treatment and Prevention of Radiation-Induced Dermatitis

Currently, there are no approved medications for the prevention and treatment of radiation-induced dermatitis, or skin discoloration/burning due to radiation therapy, because there is little evidence to guide treatment.

The purpose of the research is to better understand the factors associated with radiation-induced dermatitis and to explore the efficacy of low-dose colchicine in reducing the proportion of patients with radiation-induced dermatitis who undergo radiation treatment for head and neck cancer. If you take part in the research, you will be asked to take 0.6 mg once a day by mouth. The participants time in the study will take less than a minute a day to take the pill and 20 minutes to complete survey questions during follow-up visits.

Study Overview

• Status: Active, not recruiting
• Conditions: Radiation Therapy
• Intervention / Treatment: Drug: oral colchicine(0.6 mg) once a day

Detailed Description

A phase I study for evaluating the safety of oral colchicine in preventing and treating radiation-induced dermatitis among head and neck cancer patients who will receive RT for HNC. Prior to receiving RT, each subject will be receiving either the standard of care or low-dose oral colchicine (No randomization). There will be a comparison of the proportion of radiation-induced dermatitis in the two study arms. The individuals in the standard of care arm will receive a placebo colchicine pill once a day. Those who are in the experimental arm will receive 0.6 mg of oral colchicine once a day. The primary endpoint is the safety and tolerability of oral colchicine. The proportions of grade 2-4 radiation-induced dermatitis at the end of Radiation therapy (RT) and at the first follow-up three-four weeks post-treatment in these two study arms are the secondary study endpoints. In addition, pain, erythema, and health-related quality-of-life will be evaluated.

The study subjects will receive radiation therapy (RT) as scheduled and will meet with their clinicians for their follow-up visits.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Livingston, New Jersey, United States, 07039
      • RWJBarnabas Health - Cooperman Barnabas
    • New Brunswick, New Jersey, United States, 08901
      • Robert Wood Johnson University Hospital
    • New Brunswick, New Jersey, United States, 08901
      • Rutgers, The State University of New Jersey Board Contact:

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Eight years or older with HNC diagnosis confirmed histologically

  o Stage 1-3 HNC pathologically confirmed diagnosis of squamous cell carcinoma of the oropharynx, larynx, hypopharynx, nasopharyngeal, or oral cavity

• Plan to receive radiotherapy (>60 Gy), chemo-irradiation or bio-radiation either as primary or as a post-operative treatment to the head and neck region
• Eastern Cooperative Oncology Group Performance Status (ECOGPS) performance status 0 or 1
• Comply with the study protocol
• Capable of signing a written informed consent

Exclusion Criteria:

• An allergy, intolerance, or contraindication to colchicine
• Current treatment with colchicine for medical conditions, e.g. gout and Familial Mediterranean Fever (FMF)
• Estimated glomerular filtration rate (GFR) < 55 ml/min since colchicine should not be given
• Severe liver disease or current aminotransferase levels of more than 1.5 times the upper limit of the normal range
• Previous irradiation to the head and/or neck region
• Distant metastatic disease or locally recurrent disease
• Pre-existing skin rashes, ulcerations, or open wounds in the treatment area
• Known allergic and other systemic skin diseases even when not directly affecting irradiated fields
• Substance abuse, medical conditions, and/or social issues that would limit conduct or follow-up in the research study, in the opinion of the investigator
• Any condition that is unstable or could affect the safety of the patient and their compliance in the study as judged by the investigator
• Using high doses of non-steroidal anti-inflammatory drugs
• Pregnant and lactating women
• Psychiatric illness that would prevent the patient from giving informed consent
• Taking cetuximab or other radiosensitizing agents.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of care arm - placebo colchicine pill; The standard of care arm will receive a placebo colchicine pill once a day
Experimental: Experimental arm - oral colchicine once a day; The experimental arm will receive 0.6 mg of oral colchicine once a day	Drug: oral colchicine(0.6 mg) once a day; The standard of care arm will receive a placebo colchicine pill once a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain - Visual Analogue Scale (VAS)	Pain (within radiation fields): assessed before radiotherapy, weekly during radiotherapy, and at the end of treatment with the visual analogue scale (VAS) (from 0 = no pain to 100 = maximum pain)	10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Erythema - Common Toxicity Criteria for Adverse Events (CTCAE)	The National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) scale defines acute skin reactions to radiation occurring within the 90 days after therapy. Grade 1: faint erythema or dry desquamation. Arising within the first two to four weeks of treatment, these reactions cause skin redness, warmth, and a rash-like appearance. The patient may complain that their skin feels tight or sensitive. Grade 2: moderate to brisk erythema; patchy, moist desquamation usually confined to skin folds or creases. Moderate edema, dryness, pruritus, and flaking of skin layers (dry desquamation) also may occur. Grade 3: moist desquamation in areas other than creases and skinfolds. Bleeding may arise from minor trauma, such as abrasion. Grade 4: life-threatening consequences, such as full-thickness skin ulcers, necrosis, and spontaneous bleeding. Grade 5: death.	10 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health-Related Quality-of-Life - Questionnaire	Health-related quality of life (HRQOL) measured before, during, and after Radiation therapy, with a validated HRQOL questionnaire, European Organization for Research and Treatment of Cancer (EORTC)	10 weeks
Health-Related Quality-of-Life - Quality of Life Questionnaire	Treatment of Cancer European Organization for Research and Treatment of Cancer (EORTC). A validated questionnaire developed to assess the quality of life of cancer patients. Quality of Life Questionnaire Core Module (QLQ-C30) version- 3.	10 weeks

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Investigators: Principal Investigator: Bruce Haffty, MD, Rutgers Cancer Institute of New Jersey

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: April 13, 2022
• First Submitted That Met QC Criteria: April 13, 2022
• First Posted (Actual): April 19, 2022

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Radiation therapy; Dermatitis; Low-dose colchicine
• Additional Relevant MeSH Terms: Skin Diseases; Skin and Connective Tissue Diseases; Dermatitis; Heterocyclic Compounds; Alkaloids; Colchicine
• Other Study ID Numbers: 032112; Pro2022000357 (Other Identifier: Rutgers, The State University of New Jersey)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No