A Phase 1 interventional study of oral colchicine(0.6 mg) once a day in Radiation Therapy, sponsored by Rutgers, The State University of New Jersey. Active, not recruiting at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-20.
Sponsored by Rutgers, The State University of New Jersey · Phase 1, Interventional, and Treatment
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.
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.
1,435 studies on the registry are indexed under Dermatitis; 131 are open to participants now.
This study's planned enrollment of 30 is below the median of 64 across 1,131 interventional studies indexed under Dermatitis.
Browse Dermatitis studies →Rutgers, The State University of New Jersey is the lead sponsor of 496 studies on the registry; 130 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 30 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
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
Exclusion Criteria:
The standard of care arm will receive a placebo colchicine pill 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
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)
Time frame: 10 weeks
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.
Time frame: 10 weeks
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)
Time frame: 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.
Time frame: 10 weeks
Plan to share: No
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This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Rutgers, The State University of New Jersey