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

Sponsor

University of Louisville (Other)

Overall Status

Recruiting

CT.gov ID

NCT01874860

Collaborator

James Graham Brown Cancer Center (Other)

100

Enrollment

Location

Arms

108

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer Head and Neck Cancer	Drug: Doxycycline Drug: Hydrocortisone 1% cream Other: Sunscreen Other: Moisturizer Drug: Clindamycin Drug: Medrol-dose pack (Steroid)	Phase 2

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

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Aug 1, 2013

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Aug 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Extensive treatment group 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.	Drug: Doxycycline Doxycycline capsule, 100 mg, taken twice daily Drug: Hydrocortisone 1% cream Applied to the face, hands, feet, neck, back, and chest each evening (Topical cream) Other: Sunscreen Applied to exposed skin areas at least 30 minutes before going outdoors each morning. Other Names: SPF 30 or higher sunscreen Other: Moisturizer Applied to the face, hands, feet, neck, back, and chest each morning after sunscreen Other Names: Any frangrance-free moisturizer will do Drug: Clindamycin Recommended for daily use if rash returns (Topical cream) Other Names: Clindamycin 1 % gel Drug: Medrol-dose pack (Steroid) Patients will receive a Medrol dose-pack while continuing the extensive treatment regimen. Other Names: Medrol-dose pack
Experimental: Standard care group Patient will not receive preventive treatment but will be allowed to use sunscreen and moisturizer if desired.	Other: Sunscreen Applied to exposed skin areas at least 30 minutes before going outdoors each morning. Other Names: SPF 30 or higher sunscreen Other: Moisturizer Applied to the face, hands, feet, neck, back, and chest each morning after sunscreen Other Names: Any frangrance-free moisturizer will do

Arm

Intervention/Treatment

Experimental: Extensive treatment group

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.

Drug: Doxycycline

Doxycycline capsule, 100 mg, taken twice daily

Drug: Hydrocortisone 1% cream

Applied to the face, hands, feet, neck, back, and chest each evening (Topical cream)

Other: Sunscreen

Applied to exposed skin areas at least 30 minutes before going outdoors each morning.

Other Names:

SPF 30 or higher sunscreen

Other: Moisturizer

Applied to the face, hands, feet, neck, back, and chest each morning after sunscreen

Other Names:

Any frangrance-free moisturizer will do

Drug: Clindamycin

Recommended for daily use if rash returns (Topical cream)

Other Names:

Clindamycin 1 % gel

Drug: Medrol-dose pack (Steroid)

Patients will receive a Medrol dose-pack while continuing the extensive treatment regimen.

Other Names:

Medrol-dose pack

Experimental: Standard care group

Patient will not receive preventive treatment but will be allowed to use sunscreen and moisturizer if desired.

Other: Sunscreen

Applied to exposed skin areas at least 30 minutes before going outdoors each morning.

Other Names:

SPF 30 or higher sunscreen

Other: Moisturizer

Applied to the face, hands, feet, neck, back, and chest each morning after sunscreen

Other Names:

Any frangrance-free moisturizer will do

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.