Radiation TherapyPhase 1NCT05335148
Study to Evaluate the Safety of Colchicine
A Phase 1 study testing oral colchicine(0.6 mg) once a day in people with Radiation Therapy, run by Rutgers, The State University of New Jersey at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiation Therapy
- What is being tested?
- oral colchicine(0.6 mg) once a day
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- 10 May 2022to 1 Jun 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
RWJBarnabas Health - Cooperman Barnabas
Livingston, New Jersey, 07039
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08901
Rutgers, The State University of New Jersey Board Contact:
New Brunswick, New Jersey, 08901
About this study
Official title: Evaluate the Safety of Colchicine for Treatment and Prevention of Radiation-Induced Dermatitis
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.
Read the 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.
- Conditions
- Radiation Therapy
- Being tested
- oral colchicine(0.6 mg) once a day
- Keywords
- Radiation therapy, Dermatitis, Low-dose colchicine
- Medical subject headings
- Dermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral colchicine(0.6 mg) once a dayDrug
The standard of care arm will receive a placebo colchicine pill once a day
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: oral colchicine(0.6 mg) once a day |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 10 weeks
Secondary outcomes (1)
Erythema - Common Toxicity Criteria for Adverse Events (CTCAE)
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.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start10 May 2022
- Primary completionJun 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation TherapyStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruce G Haffty, Rutgers, The State University of New Jersey
- Investigators
- Bruce Haffty, MD, Principal investigator, Rutgers Cancer Institute of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05335148
- Sponsor's protocol ID
- 032112
- Other IDs
- Pro2022000357
- Status last verified
- May 2026
- First submitted
- 13 Apr 2022
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Safety of Colchicine for Treatment and Prevention of Radiation-Induced Dermatitis
- ClinicalTrials.gov ID
- NCT05335148
- Acronym / sponsor ID
- 032112
- Conditions
- Radiation Therapy
- Keywords
- Radiation therapy, Dermatitis, Low-dose colchicine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 10 May 2022 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 19 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Drug: oral colchicine(0.6 mg) once a dayThe experimental arm will receive 0.6 mg of oral colchicine once a day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral colchicine(0.6 mg) once a dayThe standard of care arm will receive a placebo colchicine pill once a day | Drug | Experimental arm - oral colchicine once a day |
Primary outcome
Pain - Visual Analogue Scale (VAS)
Time frame: 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)
1 secondary outcome
Erythema - Common Toxicity Criteria for Adverse Events (CTCAE)
Time frame: 10 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce Haffty, MD principal investigator
Rutgers Cancer Institute of New Jersey
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing oral colchicine(0.6 mg) once a day in people with Radiation Therapy, run by Rutgers, The State University of New Jersey at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain - Visual Analogue Scale (VAS) (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.