Evaluating colchicine for preventing skin issues from radiation therapy
Evaluate the Safety of Colchicine for Treatment and Prevention of Radiation-Induced Dermatitis
PHASE1 · Rutgers, The State University of New Jersey · NCT05335148
This study is testing if a low dose of colchicine can help prevent skin problems from radiation therapy in patients with head and neck cancer.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rutgers, The State University of New Jersey (other) |
| Drugs / interventions | cetuximab, radiation |
| Locations | 3 sites (Livingston, New Jersey and 2 other locations) |
| Trial ID | NCT05335148 on ClinicalTrials.gov |
What this trial studies
This phase I study aims to assess the safety and tolerability of low-dose oral colchicine in patients undergoing radiation therapy for head and neck cancer. Participants will take 0.6 mg of colchicine daily and will be monitored for the development of radiation-induced dermatitis compared to a placebo group. The study will also evaluate pain, skin redness, and quality of life during follow-up visits. The primary focus is on the safety of colchicine, while secondary endpoints include the incidence of dermatitis and overall patient well-being.
Who should consider this trial
Good fit: Ideal candidates are individuals aged eight or older with a confirmed diagnosis of head and neck cancer who are scheduled to receive radiation therapy.
Not a fit: Patients with allergies to colchicine, those currently receiving colchicine for other conditions, or individuals with severe kidney or liver issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new preventive treatment for radiation-induced dermatitis, improving patient comfort and quality of life during cancer treatment.
How similar studies have performed: While there is limited evidence on colchicine for this specific use, similar studies exploring treatments for radiation-induced dermatitis have shown promise, making this approach potentially beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Livingston, New Jersey and 2 other locations
- RWJBarnabas Health - Cooperman Barnabas — Livingston, New Jersey, United States (RECRUITING)
- Robert Wood Johnson University Hospital — New Brunswick, New Jersey, United States (RECRUITING)
- Rutgers, The State University of New Jersey Board Contact: — New Brunswick, New Jersey, United States (RECRUITING)
Study contacts
- Principal investigator: Bruce Haffty, MD — Rutgers Cancer Institute of New Jersey
- Study coordinator: Bruce Haffty, MD
- Email: hafftybg@cinj.rutgers.edu
- Phone: 732-235-5203
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Radiation Therapy, Radiation therapy, Dermatitis, Low-dose colchicine