Skin Rash Study Before Chemotherapy in Colorectal & Head and Neck Cancer Patients

University of Louisville (UOFL)

Status and phase

Completed

Phase 2

Conditions

Head and Neck Cancer

Colorectal Cancer

Treatments

Other: Moisturizer

Other: Sunscreen

Drug: Hydrocortisone 1% cream

Drug: Doxycycline

Drug: Medrol-dose pack (Steroid)

Drug: Clindamycin

Study type

Interventional

Funder types

Other

Identifiers

NCT01874860

BCC-OHN-GI-13

Details and patient eligibility

About

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.

Full 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.

Enrollment

24 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Prior cetuximab treatment within the 6 months of study initiation
Current treatment with tyrosine kinase inhibitors
Patients who are pregnant or incarcerated

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

24 participants in 2 patient groups

Extensive treatment group

Experimental group

Description:

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.

Treatment: