Colorectal CancerPhase 2NCT01874860
Skin Rash Study Before Chemotherapy in Colorectal & Head and Neck Cancer Patients
A Phase 2 study testing Doxycycline, Hydrocortisone 1% cream and Sunscreen in people with Colorectal Cancer and Head and Neck Cancer, run by University of Louisville at 1 site in United States.
Trial summary
The purpose of this study is to determine if using preventive treatments such as Doxycycline (an anti-biotic) capsules, sunscreen with SPF 30, Hydrocortisone 1% cream and a moisturizer will help to reduce the incidence and severity of the skin rash associated with Cetuximab (Erbitux®) when compared to receiving… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Head and Neck Cancer
- What is being tested?
- Doxycycline, Hydrocortisone 1% cream and Sunscreen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Jul 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Age greater than or equal to 18 years
- Diagnosis of colorectal or head and neck cancer
- Receipt of at least one dose of cetuximab during the study time period
Who cannot join
- Prior cetuximab treatment within the 6 months of study initiation
- Current treatment with tyrosine kinase inhibitors
- Patients who are pregnant or incarcerated
Trial locations and contacts
1 site in 1 country.
United States1 site
James Graham Brown Cancer Center
Louisville, Kentucky, 40202
About this study
Official title: Preemptive Therapy Study of Cetuximab(Erbitux®)Induced Skin Rash Using Doxycycline, Sunscreen, Hydrocortisone and Moisturizer in Colorectal and Head and Neck Cancer Patients
The purpose of this study is to determine if using preventive treatments such as Doxycycline (an anti-biotic) capsules, sunscreen with SPF 30, Hydrocortisone 1% cream and a moisturizer will help to reduce the incidence and severity of the skin rash associated with Cetuximab (Erbitux®) when compared to receiving standard care for the treatment of skin rash.
Read the detailed description
Of the 100 subjects who will participate in this study, 50 will be in the extensive treatment group and 50 will be in the standard care group. Subjects in the extensive treatment group will use Doxycycline capsule, 100 mg, taken twice daily, sunscreen SPF 30 or higher, moisturizer applied to the face, hands, feet, neck, back, and chest each morning after sunscreen, hydrocortisone 1% cream applied to the face, hands, feet, neck, back, and chest each evening.
Subjects will start taking the capsule and applying the creams three days prior to beginning cetuximab therapy. They will continue this regimen of taking the capsule and applying the creams for 8 weeks. If they develop severe skin rash as a result of cetuximab therapy, the study doctor may decide to reduce the amount of the dose of cetuximab that they receive or prescribe other medicines according to standard treatment recommendations, just as he/she would if the subject was not participating in this study. Subjects will be monitored at enrollment, 3 weeks into cetuximab treatment and at the end of cetuximab treatment for adherence, side effects and quality of life.
The standard care group will not receive preventive treatment, but they will be allowed to use sunscreen and moisturizer if desired. They, too, will be monitored at enrollment, 3 weeks into cetuximab treatment and at the end of cetuximab treatment for adherence, side effects and quality of life.
If a subject is assigned to this group and they develop a severe skin rash, the study doctor will treat their rash according to standard treatment recommendations, which may include Hydrocortisone 1% cream, Doxycycline capsules or other medications.
There will be a follow-Up period for both extensive treatment and standard care groups. At 6 months, 12 months, 18 months and 24 months, after the end of the subject's 8 week study treatment period, they will be contacted by telephone or discussed during their routine clinic visit.
- Conditions
- Colorectal Cancer, Head and Neck Cancer
- Being tested
- Doxycycline, Hydrocortisone 1% cream, Sunscreen, Moisturizer, Clindamycin
- Medical subject headings
- Colorectal Neoplasms, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxycyclineDrug
Doxycycline capsule, 100 mg, taken twice daily
Hydrocortisone 1% creamDrug
Applied to the face, hands, feet, neck, back, and chest each evening (Topical cream)
SunscreenOther
Also called SPF 30 or higher sunscreen
Applied to exposed skin areas at least 30 minutes before going outdoors each morning.
MoisturizerOther
Also called Any frangrance-free moisturizer will do
Applied to the face, hands, feet, neck, back, and chest each morning after sunscreen
ClindamycinDrug
Also called Clindamycin 1 % gel
Recommended for daily use if rash returns (Topical cream)
Medrol-dose pack (Steroid)Drug
Also called Medrol-dose pack
Patients will receive a Medrol dose-pack while continuing the extensive treatment regimen.
| Study group | Role | What they receive |
|---|---|---|
| Extensive treatment group | Experimental | Doxycycline capsule, 100 mg, taken twice daily; sunscreen SPF 30 or higher applied to exposed skin areas at least 30 minutes before going outdoors each morning; moisturizer applied to the face, hands, feet, neck, back, and chest each morning after sunscreen; Hydrocortisone 1% topical cream applied to the face, hands, feet, neck, back, and chest each evening.
For patients with grade 1 rash, hydrocortisone 1% cream and clindamycin 1% gel (tetracycline antibiotic) are recommended for daily use.
For patients with grade 2 rash, hydrocortisone cream and doxycycline 100mg twice daily or minocycline (tetracycline antibiotic) 100mg once daily is recommended.
For patients with grade 3 rash, systemic steroid therapy (a Medrol dose-pack) will be added to the grade 2 treatment. Receives: Drug: Doxycycline; Drug: Hydrocortisone 1% cream; Other: Sunscreen; Other: Moisturizer; Drug: Clindamycin; Drug: Medrol-dose pack (Steroid) |
| Standard care group | Experimental | Patient will not receive preventive treatment but will be allowed to use sunscreen and moisturizer if desired. Receives: Other: Sunscreen; Other: Moisturizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Rash
Evaluate the incidence of cetuximab-induced rash, Compare the severity of cetuximab-induced rash between the extensive treatment group (ETG) and the standard care group (SCG).
Measured: Change from Baseline, week 3, week 8
Secondary outcomes (3)
Quality of Life (QOL)
Estimate and compare the quality of life (QOL) between the extensive treatment group and standard treatment group.
Measured: Change from Baseline, week 3, week 8
Adherence to treatment regimen
Estimate and compare adherence rate in Extensive Treatment Group and Standard Treatment Group
Measured: Change in adherence from baseline to week 8
Progression Free Survival
Estimate and compare Progression-Free Survival (PFS) in extensive treatment group and standard treatment group. Survival follow-ups will be at 6 months, 12 months, 18 months, and 24 months post treatment.
Measured: Surival Follow up (6 months, 12 months, 18 months, and 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2013 (estimated)
- Study startAug 2013
- Primary completionJul 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Collaborators
- James Graham Brown Cancer Center
- Responsible party
- Principal investigator, Rebecca Redman, University of Louisville
- Investigators
- Rebecca A. Redman, MD, Principal investigator, James Graham Brown Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01874860
- Sponsor's protocol ID
- BCC-OHN-GI-13
- Status last verified
- Nov 2022
- First submitted
- 6 Jun 2013
- Last updated
- 1 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preemptive Therapy Study of Cetuximab(Erbitux®)Induced Skin Rash Using Doxycycline, Sunscreen, Hydrocortisone and Moisturizer in Colorectal and Head and Neck Cancer Patients
- ClinicalTrials.gov ID
- NCT01874860
- Acronym / sponsor ID
- BCC-OHN-GI-13
- Conditions
- Colorectal Cancer, Head and Neck Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Collaborators
- James Graham Brown Cancer Center
- Study start
- Aug 2013 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 11 Jun 2013 (estimated)
- 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.
The purpose of this study is to determine if using preventive treatments such as Doxycycline (an anti-biotic) capsules, sunscreen with SPF 30, Hydrocortisone 1% cream and a moisturizer will help to reduce the incidence and severity of the skin rash associated with Cetuximab (Erbitux®) when compared to receiving standard care for the treatment of skin rash.
Detailed description
Of the 100 subjects who will participate in this study, 50 will be in the extensive treatment group and 50 will be in the standard care group. Subjects in the extensive treatment group will use Doxycycline capsule, 100 mg, taken twice daily, sunscreen SPF 30 or higher, moisturizer applied to the face, hands, feet, neck, back, and chest each morning after sunscreen, hydrocortisone 1% cream applied to the face, hands, feet, neck, back, and chest each evening.
Subjects will start taking the capsule and applying the creams three days prior to beginning cetuximab therapy. They will continue this regimen of taking the capsule and applying the creams for 8 weeks. If they develop severe skin rash as a result of cetuximab therapy, the study doctor may decide to reduce the amount of the dose of cetuximab that they receive or prescribe other medicines according to standard treatment recommendations, just as he/she would if the subject was not participating in this study. Subjects will be monitored at enrollment, 3 weeks into cetuximab treatment and at the end of cetuximab treatment for adherence, side effects and quality of life.
The standard care group will not receive preventive treatment, but they will be allowed to use sunscreen and moisturizer if desired. They, too, will be monitored at enrollment, 3 weeks into cetuximab treatment and at the end of cetuximab treatment for adherence, side effects and quality of life.
If a subject is assigned to this group and they develop a severe skin rash, the study doctor will treat their rash according to standard treatment recommendations, which may include Hydrocortisone 1% cream, Doxycycline capsules or other medications.
There will be a follow-Up period for both extensive treatment and standard care groups. At 6 months, 12 months, 18 months and 24 months, after the end of the subject's 8 week study treatment period, they will be contacted by telephone or discussed during their routine clinic visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extensive treatment group | Experimental | Drug: Doxycycline, Drug: Hydrocortisone 1% cream, Other: Sunscreen, Other: Moisturizer, Drug: Clindamycin, Drug: Medrol-dose pack (Steroid)Doxycycline capsule, 100 mg, taken twice daily; sunscreen SPF 30 or higher applied to exposed skin areas at least 30 minutes before going outdoors each morning; moisturizer applied to the face, hands, feet, neck, back, and chest each morning after sunscreen; Hydrocortisone 1% topical cream applied to the face, hands, feet, neck, back, and chest each evening. For patients with grade 1 rash, hydrocortisone 1% cream and clindamycin 1% gel (tetracycline antibiotic) are recommended for daily use. For patients with grade 2 rash, hydrocortisone cream and doxycycline 100mg twice daily or minocycline (tetracycline antibiotic) 100mg once daily is recommended. For patients with grade 3 rash, systemic steroid therapy (a Medrol dose-pack) will be added to the grade 2 treatment. |
| Standard care group | Experimental | Other: Sunscreen, Other: MoisturizerPatient will not receive preventive treatment but will be allowed to use sunscreen and moisturizer if desired. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age greater than or equal to 18 years
- Diagnosis of colorectal or head and neck cancer
- Receipt of at least one dose of cetuximab during the study time period
Key exclusion criteria (3 listed)
- Prior cetuximab treatment within the 6 months of study initiation
- Current treatment with tyrosine kinase inhibitors
- Patients who are pregnant or incarcerated
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 |
|---|---|---|
| DoxycyclineDoxycycline capsule, 100 mg, taken twice daily | Drug | Extensive treatment group |
| Hydrocortisone 1% creamApplied to the face, hands, feet, neck, back, and chest each evening (Topical cream) | Drug | Extensive treatment group |
| SunscreenAlso: SPF 30 or higher sunscreenApplied to exposed skin areas at least 30 minutes before going outdoors each morning. | Other | Extensive treatment group, Standard care group |
| MoisturizerAlso: Any frangrance-free moisturizer will doApplied to the face, hands, feet, neck, back, and chest each morning after sunscreen | Other | Extensive treatment group, Standard care group |
| ClindamycinAlso: Clindamycin 1 % gelRecommended for daily use if rash returns (Topical cream) | Drug | Extensive treatment group |
| Medrol-dose pack (Steroid)Also: Medrol-dose packPatients will receive a Medrol dose-pack while continuing the extensive treatment regimen. | Drug | Extensive treatment group |
Primary outcome
Incidence of Rash
Time frame: Change from Baseline, week 3, week 8
Evaluate the incidence of cetuximab-induced rash, Compare the severity of cetuximab-induced rash between the extensive treatment group (ETG) and the standard care group (SCG).
3 secondary outcomes
Quality of Life (QOL)
Time frame: Change from Baseline, week 3, week 8
Adherence to treatment regimen
Time frame: Change in adherence from baseline to week 8
Progression Free Survival
Time frame: Surival Follow up (6 months, 12 months, 18 months, and 24 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2022.
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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.
Rebecca A. Redman, MD principal investigator
James Graham Brown Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Doxycycline, Hydrocortisone 1% cream and Sunscreen in people with Colorectal Cancer and Head and Neck Cancer, run by University of Louisville at 1 site 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 1 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of Rash (time frame: Change from Baseline, week 3, week 8). 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 1 Dec 2022.