Colorectal Cancer, Head and Neck Cancer
Conditions
Brief 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 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.
Interventions
DRUGDoxycycline
Doxycycline capsule, 100 mg, taken twice daily
Applied to the face, hands, feet, neck, back, and chest each evening (Topical cream)
OTHERSunscreen
Applied to exposed skin areas at least 30 minutes before going outdoors each morning.
OTHERMoisturizer
Applied to the face, hands, feet, neck, back, and chest each morning after sunscreen
DRUGClindamycin
Recommended for daily use if rash returns (Topical cream)
DRUGMedrol-dose pack (Steroid)
Patients will receive a Medrol dose-pack while continuing the extensive treatment regimen.
Sponsors
James Graham Brown Cancer Center
University of Louisville
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age greater than or equal to 18 years 2. Diagnosis of colorectal or head and neck cancer 3. Receipt of at least one dose of cetuximab during the study time period
Exclusion criteria
1. Prior cetuximab treatment within the 6 months of study initiation 2. Current treatment with tyrosine kinase inhibitors 3. Patients who are pregnant or incarcerated
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Rash | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life (QOL) | Change from Baseline, week 3, week 8 | Estimate and compare the quality of life (QOL) between the extensive treatment group and standard treatment group. |
| Adherence to treatment regimen | Change in adherence from baseline to week 8 | Estimate and compare adherence rate in Extensive Treatment Group and Standard Treatment Group |
| Progression Free Survival | Surival Follow up (6 months, 12 months, 18 months, and 24 months) | 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. |
Countries
United States
Outcome results
None listed