Last updated: November 8, 2023
Sponsor: Rutgers, The State University of New Jersey
Overall Status: Active - Recruiting
Phase
1
Condition
Cancer Treatment
Treatment
oral colchicine(0.6 mg) once a day
Clinical Study ID
NCT05335148
032112
Pro2022000357
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Eight years or older with HNC diagnosis confirmed histologically o Stage 1-3 HNC pathologically confirmed diagnosis of squamous cell carcinoma of theoropharynx, larynx, hypopharynx, nasopharyngeal, or oral cavity
- Plan to receive radiotherapy (>60 Gy), chemo-irradiation or bio-radiation either asprimary 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
Exclusion Criteria:
- An allergy, intolerance, or contraindication to colchicine
- Current treatment with colchicine for medical conditions, e.g. gout and FamilialMediterranean Fever (FMF)
- Estimated glomerular filtration rate (GFR) < 55 ml/min since colchicine should not begiven
- Severe liver disease or current aminotransferase levels of more than 1.5 times theupper 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 affectingirradiated fields
- Substance abuse, medical conditions, and/or social issues that would limit conduct orfollow-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 theircompliance 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 Design
Total Participants: 30
Treatment Group(s): 1
Primary Treatment: oral colchicine(0.6 mg) once a day
Phase: 1
Study Start date:
May 10, 2022
Estimated Completion Date:
June 01, 2024
Study Description
Connect with a study center
RWJBarnabas Health - Cooperman Barnabas
Livingston, New Jersey 07039
United StatesActive - Recruiting
Robert Wood Johnson University Hospital
New Brunswick, New Jersey 08901
United StatesActive - Recruiting
Rutgers, The State University of New Jersey Board Contact:
New Brunswick, New Jersey 08901
United StatesActive - Recruiting
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