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

  • STATUS
    Recruiting
  • End date
    Aug 25, 2022
  • participants needed
    100
  • sponsor
    University of Louisville
Updated on 25 January 2021
cetuximab
erbitux

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.

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.

Details
Condition Colorectal Cancer, Rectal disorder, head and neck cancer, Colon Cancer Screening, Rectal Disorders, Colon cancer; rectal cancer, colorectal neoplasm, colorectal cancers, cancer of the head and neck, cancer, colorectal, colorectal tumor, tumors, colorectal
Treatment Clindamycin, doxycycline, Sunscreen, Hydrocortisone 1% cream, Moisturizer, Medrol-dose pack (Steroid)
Clinical Study IdentifierNCT01874860
SponsorUniversity of Louisville
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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