Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
30 participants
INTERVENTIONAL
2022-05-10
2024-06-01
Brief Summary
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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.
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Detailed Description
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The study subjects will receive radiation therapy (RT) as scheduled and will meet with their clinicians for their follow-up visits.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard of care arm - placebo colchicine pill
The standard of care arm will receive a placebo colchicine pill once a day
No interventions assigned to this group
Experimental arm - oral colchicine once a day
The experimental arm will receive 0.6 mg of oral colchicine once a day
oral colchicine(0.6 mg) once a day
The standard of care arm will receive a placebo colchicine pill once a day
Interventions
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oral colchicine(0.6 mg) once a day
The standard of care arm will receive a placebo colchicine pill once a day
Eligibility Criteria
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Inclusion Criteria
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
* 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.
18 Years
ALL
No
Sponsors
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Rutgers, The State University of New Jersey
OTHER
Responsible Party
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Bruce G Haffty
Associate Vice Chancellor Cancer Programs Professor and Chairman Department of Radiation Oncology
Principal Investigators
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Bruce Haffty, MD
Role: PRINCIPAL_INVESTIGATOR
Rutgers Cancer Institute of New Jersey
Locations
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RWJBarnabas Health - Cooperman Barnabas
Livingston, New Jersey, United States
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States
Rutgers, The State University of New Jersey Board Contact:
New Brunswick, New Jersey, United States
Countries
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Central Contacts
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Facility Contacts
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Bruce Haffty, MD
Role: primary
Other Identifiers
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Pro2022000357
Identifier Type: OTHER
Identifier Source: secondary_id
032112
Identifier Type: -
Identifier Source: org_study_id
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