Study to Evaluate the Safety of Colchicine

NCT05335148 | Unknown Phase 1 DMC FDA Drug

• 2 other identifiers: 032112Pro2022000357
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

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 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.

Conditions

Radiation Therapy

Keywords

Radiation therapy; Dermatitis; Low-dose colchicine

Outcome Measures

Primary Outcomes (1)

• 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)

  10 weeks

Secondary Outcomes (1)

• Erythema - Common Toxicity Criteria for Adverse Events (CTCAE)

  10 weeks

Other Outcomes (2)

• Health-Related Quality-of-Life - Questionnaire

  10 weeks

• Health-Related Quality-of-Life - Quality of Life Questionnaire

  10 weeks

Study Arms (2)

Standard of care arm - placebo colchicine pill

NO INTERVENTION

The standard of care arm will receive a placebo colchicine pill once a day

Experimental arm - oral colchicine once a day

EXPERIMENTAL

The experimental arm will receive 0.6 mg of oral colchicine once a day

Drug: oral colchicine(0.6 mg) once a day

Interventions

oral colchicine(0.6 mg) once a day DRUG

The standard of care arm will receive a placebo colchicine pill once a day

Experimental arm - oral colchicine once a day

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (3)

RWJBarnabas Health - Cooperman Barnabas

Livingston, New Jersey, 07039, United States

RECRUITING

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08901, United States

RECRUITING

Rutgers, The State University of New Jersey Board Contact:

New Brunswick, New Jersey, 08901, United States

RECRUITING

MeSH Terms

Conditions

Dermatitis

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Study Officials

• Bruce Haffty, MD

  Rutgers Cancer Institute of New Jersey

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bruce Haffty, MD

CONTACT

732-235-5203; hafftybg@cinj.rutgers.edu

Naomi Schlesinger

CONTACT

732-235-7217; schlesna@rwjms.rutgers.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Vice Chancellor Cancer Programs Professor and Chairman Department of Radiation Oncology

Model Details: Perform a phase I study for evaluating the safety of oral colchicine in preventing and treating radiation-induced dermatitis among head and neck cancer patients.

Study Record Dates

• First Submitted: April 13, 2022
• First Posted: April 19, 2022
• Study Start: May 10, 2022
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: November 9, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)