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

November 29, 2022 updated by: Rebecca Redman, University of Louisville

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • James Graham Brown Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Change from Baseline, week 3, week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life (QOL)
Time Frame: Change from Baseline, week 3, week 8
Estimate and compare the quality of life (QOL) between the extensive treatment group and standard treatment group.
Change from Baseline, week 3, week 8
Adherence to treatment regimen
Time Frame: Change in adherence from baseline to week 8
Estimate and compare adherence rate in Extensive Treatment Group and Standard Treatment Group
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)
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.
Surival Follow up (6 months, 12 months, 18 months, and 24 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Louisville

Collaborators

James Graham Brown Cancer Center

Investigators

  • Principal Investigator: Rebecca A. Redman, MD, James Graham Brown Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2013

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

June 6, 2013

First Submitted That Met QC Criteria

June 10, 2013

First Posted (Estimate)

June 11, 2013

Study Record Updates

Last Update Posted (Actual)

December 1, 2022

Last Update Submitted That Met QC Criteria

November 29, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCC-OHN-GI-13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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