Status:
UNKNOWN
Study to Evaluate the Safety of Colchicine
Lead Sponsor:
Rutgers, The State University of New Jersey
Conditions:
Radiation Therapy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 ...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05335148
Start Date
May 10 2022
End Date
June 1 2024
Last Update
November 9 2023
Active Locations (3)
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1
RWJBarnabas Health - Cooperman Barnabas
Livingston, New Jersey, United States, 07039
2
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States, 08901
3
Rutgers, The State University of New Jersey Board Contact:
New Brunswick, New Jersey, United States, 08901