Radiation Therapy
Conditions
Keywords
Radiation therapy, Dermatitis, Low-dose colchicine
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.
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 RT, each subject will be receiving either the standard of care or low-dose oral colchicine (No randomization). There will be a comparison of the proportion of radiation-induced dermatitis in the two study arms. The individuals in the standard of care arm will receive a placebo colchicine pill once a day. Those who are in the experimental arm will receive 0.6 mg of oral colchicine once a day. The primary endpoint is the safety and tolerability of oral colchicine. The proportions of grade 2-4 radiation-induced dermatitis at the end of Radiation therapy (RT) and at the first follow-up three-four weeks post-treatment in these two study arms are the secondary study endpoints. In addition, pain, erythema, and health-related quality-of-life will be evaluated. The study subjects will receive radiation therapy (RT) as scheduled and will meet with their clinicians for their follow-up visits.
Interventions
DRUGoral colchicine(0.6 mg) once a day
The standard of care arm will receive a placebo colchicine pill once a day
Sponsors
Rutgers, The State University of New Jersey
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain - Visual Analogue Scale (VAS) | 10 weeks | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Erythema - Common Toxicity Criteria for Adverse Events (CTCAE) | 10 weeks | The National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) scale defines acute skin reactions to radiation occurring within the 90 days after therapy. Grade 1: faint erythema or dry desquamation. Arising within the first two to four weeks of treatment, these reactions cause skin redness, warmth, and a rash-like appearance. The patient may complain that their skin feels tight or sensitive. Grade 2: moderate to brisk erythema; patchy, moist desquamation usually confined to skin folds or creases. Moderate edema, dryness, pruritus, and flaking of skin layers (dry desquamation) also may occur. Grade 3: moist desquamation in areas other than creases and skinfolds. Bleeding may arise from minor trauma, such as abrasion. Grade 4: life-threatening consequences, such as full-thickness skin ulcers, necrosis, and spontaneous bleeding. Grade 5: death. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORBruce Haffty, MD
Rutgers Cancer Institute of New Jersey
Outcome results
None listed